Paroxetine - Congenital, Prenatal & Neonatal Adverse Rections

This table shows all Adverse Drug Reactions reported to the FDA's Adverse Event Reporting System between 2004 and the 2nd Quarter of 2008 where the listed psychiatric drug was identified as the Primary Suspect Drug (FDA's term) deemed responsible for causing or inducing these reactions and where one or more of the Adverse Reactions reported for the Case described a congenital, prenatal or neonatal condition. Where no Age, Date of Event or Indication (the condition being treated) are shown, none were present in the FDA records.

Reported By: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR (Individual Safety Report).

The Oxford English Dictionary defines a poison as "a substance that causes death or harm when introduced into or absorbed by a living organism."  This psychiatric drug fits that definition.


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Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 3793986 4766220 09/09/2005 Paxil Agitation Neonatal, Apathy, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypertonia Neonatal, Irritability, Lethargy, Neonatal Disorder, Premature Baby
F 3794136 4393737 07/09/2004 Paroxetine CN Abortion Spontaneous, Overdose
M 3964349 4766214 09/09/2005 Paxil Bleeding Time Prolonged, Blood PH Decreased, Clonus, Convulsion Neonatal, CSF Protein Increased, Drug Exposure During Pregnancy, Eye Movement Disorder, High-Pitched Crying, Hypertonia Neonatal, Lumbar Puncture Abnormal, Neonatal Disorder, Red Blood Cells CSF Positive, Subarachnoid Haemorrhage
F 4003901 4282182 01/30/2004 Paxil CN Anxiety Abdominal Discomfort, Abdominal Pain Upper, Abortion Spontaneous, Aggression, Agitation, Anaemia, Anger, Anxiety, Blood Pressure Systolic Decreased, Cellulitis, Confusional State, Convulsion, Dehydration, Dependence, Dizziness, Drug Dependence, Drug Tolerance, Drug Withdrawal Syndrome, Gastroenteritis, Influenza, Insomnia, Motor Dysfunction, Nausea, Nightmare, Oedema Peripheral, Ovarian Cyst, Pharyngitis, Pharyngolaryngeal Pain, Pulmonary Congestion, Pyrexia, Rash, Sensory Disturbance, Suicidal Ideation, Throat Tightness, Tremor, Uterine Leiomyoma, Vaginitis, Viral Infection, Vision Blurred, Vomiting
M 4006550 5333652 06/08/2002 05/24/2007 08/21/2002 Paxil LW Cardiogenic Shock, Coronary Artery Dilatation, Dilatation Ventricular, Disseminated Intravascular Coagulation, Drug Exposure During Pregnancy, Hypotension, Mitral Valve Stenosis, Premature Labour, Respiratory Distress, Sepsis, Tricuspid Valve Disease, Tricuspid Valve Incompetence
M 4006550 5443342 06/08/2002 09/05/2007 08/21/2002 Paxil LW Cardiac Failure, Cardiogenic Shock, Coronary Artery Dilatation, Dilatation Ventricular, Disseminated Intravascular Coagulation, Drug Exposure During Pregnancy, Heart Disease Congenital, Hypotension, Mitral Valve Stenosis, Premature Labour, Respiratory Distress, Sepsis, Tricuspid Valve Disease, Tricuspid Valve Incompetence
M 4006550 5557523 06/08/2002 12/14/2007 08/21/2002 Paxil MD Anxiety Atrial Septal Defect, Bradycardia, Cardiac Failure, Cardiac Failure Congestive, Cardiac Murmur, Cardiac Valve Disease, Cardiogenic Shock, Cardiomegaly, Coagulopathy, Congenital Heart Valve Disorder, Coronary Artery Dilatation, Dilatation Ventricular, Disseminated Intravascular Coagulation, Drug Exposure During Pregnancy, Eating Disorder, Failure To Thrive, Haemodynamic Instability, Heart Disease Congenital, Hypochloraemia, Hyponatraemia, Hypotension, Metabolic Acidosis, Mitral Valve Stenosis, Multi-Organ Failure, Premature Labour, Pulmonary Hypertension, Pulmonary Hypoplasia, Pulmonary Oedema, Pyrexia, Renal Failure, Respiratory Distress, Respiratory Failure, Right Atrial Dilatation, Sepsis, Septic Shock, Supraventricular Tachycardia, Tachypnoea, Tricuspid Valve Disease, Tricuspid Valve Incompetence, White Blood Cell Count Increased
M 4006550 5669383 06/08/2002 03/17/2008 08/21/2002 Paxil MD Anxiety Atrial Septal Defect, Bradycardia, Cardiac Failure, Cardiac Failure Congestive, Cardiac Murmur, Cardiac Valve Disease, Cardiogenic Shock, Cardiomegaly, Coagulopathy, Congenital Heart Valve Disorder, Coronary Artery Dilatation, Dilatation Ventricular, Disseminated Intravascular Coagulation, Drug Exposure During Pregnancy, Eating Disorder, Failure To Thrive, Haemodynamic Instability, Heart Disease Congenital, Hypochloraemia, Hyponatraemia, Hypotension, Metabolic Acidosis, Mitral Valve Stenosis, Multi-Organ Failure, Premature Labour, Pulmonary Hypertension, Pulmonary Hypoplasia, Pulmonary Oedema, Pyrexia, Renal Failure, Respiratory Distress, Respiratory Failure, Right Atrial Dilatation, Sepsis, Septic Shock, Supraventricular Tachycardia, Tachypnoea, Tricuspid Valve Disease, Tricuspid Valve Incompetence, White Blood Cell Count Increased
M 4040749 4766221 09/09/2005 Paxil Agitation Neonatal, Alpha Haemolytic Streptococcal Infection, Apgar Score Low, Blood Sodium Decreased, Caesarean Section, C-Reactive Protein Increased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Distress Syndrome, Hypertonia Neonatal, Hypoglycaemia Neonatal, Opisthotonus, Salivary Hypersecretion
M 4056679 4266737 12/06/2003 01/08/2004 Paxil MD Apnoea, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia
M 4056679 5232536 12/06/2003 02/07/2007 Paxil MD Apnoea, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypotonia, Irritability, Respiratory Disorder Neonatal
M 4056679 5234443 12/06/2003 02/09/2007 Paxil MD Borderline Personality Disorder Agitation Neonatal, Apnoea, Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypotonia, Irritability, Neonatal Asphyxia, Neonatal Disorder, Respiratory Disorder Neonatal, Tremor, Vomiting
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 4067215 4275509 01/21/2004 Paxil CR CN Abortion Spontaneous
M 4072534 4279472 03/01/2003 01/27/2004 Deroxat MD Aspiration, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Foetal Distress Syndrome, Neonatal Aspiration
4072539 4279481 01/01/2003 01/27/2004 Deroxat MD Drug Exposure During Pregnancy, Hypotonia, Neonatal Disorder, Tremor
F 4072539 4380602 01/01/2003 06/18/2004 Deroxat MD Depression Developmental Coordination Disorder, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypersomnia, Hypotonia, Poor Weight Gain Neonatal, Tremor
M 4074188 4277001 01/09/2004 Paxil Atrophy, Convulsion Neonatal, Dilatation Ventricular, Epilepsy, Eye Movement Disorder, Fontanelle Bulging, Hypotonia, Intraventricular Haemorrhage Neonatal, Lethargy, Maternal Drugs Affecting Foetus, Neonatal Apnoeic Attack, Neonatal Disorder, Nervous System Disorder
M 4075542 4282216 01/14/2004 01/30/2004 Paxil MD Caesarean Section, Drug Exposure During Pregnancy, Respiratory Acidosis, Respiratory Depression
M 4075542 4300378 01/14/2004 02/20/2004 Paxil MD Neurosis Drug Exposure During Pregnancy, Neonatal Respiratory Acidosis, Neonatal Respiratory Depression, Respiratory Depression
M 4075542 4334495 01/14/2004 04/07/2004 Paxil MD Neurosis Caesarean Section, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus, Neonatal Respiratory Depression, Respiratory Acidosis, Respiratory Depression
4075543 4282217 01/30/2004 Deroxat CN Depression Drug Exposure During Pregnancy, Heart Disease Congenital
4075543 4284155 02/03/2004 Deroxat CN Depression Drug Exposure During Pregnancy, Heart Disease Congenital
4077960 4283575 06/18/2001 02/02/2004 Seroxat PH Convulsion, Convulsion Neonatal, Dilatation Ventricular, Epilepsy, Eye Movement Disorder, Fontanelle Bulging, Hypotonia, Hypotonia Neonatal, Intraventricular Haemorrhage Neonatal, Joint Hyperextension, Lethargy, Maternal Drugs Affecting Foetus, Neonatal Apnoeic Attack, Nervous System Disorder, Respiratory Disorder, Respiratory Disorder Neonatal, Visual Evoked Potentials Abnormal, Vomiting
M 4077963 4283581 02/02/2004 Paroxetine CN Apnoea, Convulsion, Convulsion Neonatal, Dilatation Ventricular, Eye Movement Disorder, Fontanelle Bulging, Hypotonia, Hypotonia Neonatal, Intraventricular Haemorrhage, Irritability, Joint Hyperextension, Lethargy, Maternal Drugs Affecting Foetus, Neonatal Apnoeic Attack, Nervous System Disorder, Visual Evoked Potentials Abnormal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 4079774 4285118 11/01/2003 02/04/2004 Deroxat CN Abdominal Wall Anomaly, Abortion Induced, Anorectal Disorder, Chromosome Abnormality, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Urinary Tract Malformation
F 4079774 4286742 11/01/2003 02/06/2004 Deroxat CN Abdominal Wall Anomaly, Abortion Induced, Anorectal Disorder, Bladder Disorder, Chromosome Abnormality, Congenital Anomaly, Drug Exposure During Pregnancy, Urinary Tract Malformation
F 4079774 4288616 11/01/2003 02/09/2004 Deroxat CN Abdominal Wall Anomaly, Abortion Induced, Anorectal Disorder, Chromosome Abnormality, Congenital Bladder Anomaly, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus, Urinary Tract Malformation
M 4081503 4286733 01/20/2004 02/06/2004 Paxil CN Developmental Delay, Drug Exposure During Pregnancy, Poland's Syndrome, Syndactyly, Vascular Anomaly
M 4081503 4313517 01/20/2004 03/08/2004 Paxil CN Anxiety Developmental Delay, Drug Exposure During Pregnancy, Poland's Syndrome, Syndactyly, Vascular Anomaly
F 4082921 4287711 09/02/2003 02/09/2004 Paxil CN Dizziness, Drug Exposure During Pregnancy
F 4083397 4288226 08/01/2003 02/09/2004 Paxil CN Dizziness, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
F 4083555 4391411 03/01/2003 07/07/2004 Paxil CN Ill-Defined Disorder Abortion Spontaneous, Arthralgia, Asthenia, Blood Disorder, Dehydration, Diarrhoea, Disturbance In Attention, Loss of Libido, Muscle Cramp, Weight Increased
F 4083585 4288417 01/01/2003 02/09/2004 Paxil CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
F 4083599 4288431 09/01/2003 02/09/2004 Paxil CN Drug Exposure During Pregnancy, Paraesthesia
F 4084914 4290779 01/01/1997 02/11/2004 Paxil CN Depression Agitation, Crying, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Dyspepsia, Feeling Abnormal, Hyperhidrosis, Irritability, Nausea, Paraesthesia, Restlessness
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 4085403 4291320 02/11/2004 Paxil CN Panic Attack Drug Exposure During Pregnancy, Excitability, Nausea, Sexual Dysfunction, Weight Decreased
F 4085412 4291329 02/11/2004 Paxil CN Abortion Spontaneous, Drug Exposure During Pregnancy
F 4086463 4292825 02/12/2004 Paxil CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
F 4086463 4295495 02/16/2004 Paxil CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
F 4086463 4574523 02/08/2005 Paxil LW Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
F 4086463 4603917 01/01/1996 03/10/2005 Paxil MD Anxiety Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Scar, Umbilical Cord Around Neck
F 4086463 4615118 01/01/1996 03/22/2005 Paxil MD Anxiety Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Scar, Umbilical Cord Around Neck
F 4095781 4305184 02/26/2004 Paxil LW Drug Use for Unknown Indication Abortion Spontaneous, Aggression, Agitation, Anxiety, Complications of Maternal Exposure To Therapeutic Drugs, Confusional State, Disability, Disturbance In Attention, Dizziness, Drug Withdrawal Syndrome, Fatigue, Headache, Lethargy, Maternal Drugs Affecting Foetus, Memory Impairment, Migraine, Nervousness, Nightmare, Paraesthesia, Performance Status Decreased, Sleep Disorder, Suicidal Ideation, Tremor
F 4099149 4308397 03/01/2004 Paroxetine CN Bradycardia, Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Electroencephalogram Abnormal, Encephalopathy Neonatal, Hypopnoea, Hypotonia
M 4099617 4309147 03/02/2004 Paxil LW Drug Use for Unknown Indication Abortion Spontaneous, Aggression, Agitation, Disability, Dizziness, Drug Withdrawal Syndrome, Nausea, Paraesthesia, Performance Status Decreased, Suicidal Ideation, Tremor, Vertigo, Vomiting
F 4099661 4309223 03/02/2004 Paxil LW Drug Use for Unknown Indication Abdominal Pain, Abortion Spontaneous, Aggression, Agitation, Asthenia, Disability, Disturbance In Attention, Drug Withdrawal Syndrome, Fatigue, Hyperhidrosis, Influenza, Memory Impairment, Nausea, Nightmare, Performance Status Decreased, Sleep Disorder, Vomiting
F 4099698 4309280 03/02/2004 Paxil LW Drug Use for Unknown Indication Aggression, Agitation, Anxiety, Confusional State, Disturbance In Attention, Dizziness, Drug Withdrawal Syndrome, Fatigue, Headache, Hyperhidrosis, Lethargy, Memory Impairment, Migraine, Nausea, Nervousness, Nightmare, Paraesthesia, Sleep Disorder, Suicidal Ideation, Tremor, Vertigo, Vomiting
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 4099700 4309284 03/02/2004 Paxil LW Drug Use for Unknown Indication Abdominal Pain, Abortion Spontaneous, Aggression, Agitation, Anxiety, Asthenia, Confusional State, Diarrhoea, Disturbance In Attention, Dizziness, Drug Withdrawal Syndrome, Fatigue, Headache, Hyperhidrosis, Influenza, Lethargy, Memory Impairment, Migraine, Nervousness, Nightmare, Paraesthesia, Performance Status Decreased, Sleep Disorder, Tremor, Vertigo
F 4099708 4309291 03/02/2004 Paxil LW Drug Use for Unknown Indication Abdominal Pain, Abortion Spontaneous, Aggression, Agitation, Anxiety, Asthenia, Confusional State, Diarrhoea, Disability, Disturbance In Attention, Dizziness, Drug Withdrawal Syndrome, Fatigue, Headache, Hyperhidrosis, Influenza, Lethargy, Memory Impairment, Migraine, Nausea, Nervousness, Nightmare, Performance Status Decreased, Self Mutilation, Sleep Disorder, Suicidal Ideation, Vertigo, Vomiting
4101620 4312322 10/17/2000 03/05/2004 Deroxat CN Depression Cardiac Failure, Circulatory Failure Neonatal, Cystic Fibrosis Pancreatic, Drug Exposure During Pregnancy, Encephalopathy, Encephalopathy Neonatal, Enterocolitis, Facial Dysmorphism, Mitral Valve Incompetence, Neonatal Cardiac Failure, Neonatal Hypotension, Premature Baby, Renal Failure Acute, Renal Failure Neonatal
M 4102558 4313537 01/28/2004 03/08/2004 Paxil MD Neonatal Tachypnoea, Tremor
M 4102558 4317957 01/28/2004 03/16/2004 Paxil MD Congenital Atrial Septal Defect, Cyanosis, Cyanosis Neonatal, Drug Withdrawal Syndrome Neonatal, Ill-Defined Disorder, Intercostal Retraction, Maternal Drugs Affecting Foetus, Micrognathia, Muscle Rigidity, Neonatal Asphyxia, Neonatal Tachypnoea, Respiratory Acidosis, Tremor, Tremor Neonatal
M 4102558 4322094 01/28/2004 03/23/2004 Paxil MD Congenital Atrial Septal Defect, Cyanosis, Foetal Valproate Syndrome, Intercostal Retraction, Irritability, Maternal Drugs Affecting Foetus, Micrognathia, Muscle Rigidity, Neonatal Asphyxia, Neonatal Tachypnoea, Respiratory Acidosis, Tremor, Tricuspid Valve Incompetence
M 4102558 4328191 01/28/2004 03/31/2004 Paxil MD Apgar Score Low, Asphyxia, Congenital Atrial Septal Defect, Cyanosis, Drug Withdrawal Syndrome, Hypertonia, Intercostal Retraction, Irritability, Maternal Drugs Affecting Foetus, Micrognathia, Neonatal Asphyxia, Neonatal Tachypnoea, Nervous System Disorder, Respiratory Acidosis, Tremor, Tricuspid Valve Incompetence
4103141 4314395 01/01/2004 03/09/2004 Paxil CR CN Drug Use for Unknown Indication Convulsion, Depressed Level of Consciousness, Drug Exposure During Pregnancy
4103141 4327133 01/01/2004 03/30/2004 Paxil CR CN Generalised Anxiety Disorder Coma Neonatal, Convulsion, Convulsion Neonatal, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Grand Mal Convulsion
F 4107867 4317639 03/15/2004 Paxil CN Congenital Anomaly, Drug Exposure During Pregnancy
F 4113493 4323406 02/19/2004 03/25/2004 Paroxetine PH Drug Abuser, Drug Exposure During Pregnancy
F 4113493 4336672 02/19/2004 04/12/2004 Paroxetine PH Complications of Maternal Exposure To Therapeutic Drugs, Drug Abuser, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 4114645 4324810 03/02/2004 03/26/2004 Deroxat CN Depression Agitation, Disturbance In Attention, Drug Exposure During Pregnancy, Dyskinesia, Electroencephalogram Abnormal, Hypertonia, Hypotonia Neonatal, Oculogyration, Sleep Disorder, Tremor Neonatal
F 4115281 4323335 03/24/2004 Paxil CN Abortion Spontaneous, Anger, Anxiety, Crying, Depression, Drug Dependence, Drug Withdrawal Syndrome, Feeling Abnormal, Migraine, Movement Disorder, Panic Attack, Self-Injurious Ideation, Suicidal Ideation
F 4116474 4324665 03/25/2004 Paxil CN Panic Attack Complications of Maternal Exposure To Therapeutic Drugs, Depression, Feeling of Despair, Post-Traumatic Stress Disorder, Self-Injurious Ideation
4121621 4334511 04/07/2004 Paroxetine CN Obsessive-Compulsive Disorder Drug Exposure During Pregnancy, Ureteric Stenosis
F 4127239 4338039 04/07/2004 Paxil Blood Lactic Acid Increased, Bradycardia Neonatal, Clonus, Convulsion Neonatal, Cyanosis Neonatal, Drug Withdrawal Syndrome Neonatal, Hypertonia, Hypopnoea, Hypotonia, Maternal Drugs Affecting Foetus
F 4127239 4766207 09/09/2005 Paxil Blood Lactic Acid Increased, Blood PH Decreased, Bradycardia Neonatal, Carbon Dioxide Increased, Clonus, Convulsion Neonatal, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Electroencephalogram Abnormal, Hypertonia Neonatal, Hypopnoea, Hypotonia Neonatal, Neonatal Disorder
4133264 4350943 04/30/2004 Paroxetine CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Jittery, Gastric Disorder, Hypertonia, Hypoglycaemia, Opisthotonus, Salivary Hypersecretion
F 4148180 4365356 05/25/2004 Paxil Agitation, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Disorder, Neonatal Respiratory Distress Syndrome
F 4163157 4388714 07/01/2004 Paxil CR CN Depression Dizziness, Drug Exposure During Pregnancy, Headache, Insomnia, Paraesthesia, Suicidal Ideation, Tinnitus
F 4166129 4404186 07/19/2004 Paroxetine CN Anxiety, Drug Exposure During Pregnancy Bradycardia Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy, Electroencephalogram Abnormal, Hypopnoea, Hypotonia Neonatal, Respiratory Disorder Neonatal
4167763 4396310 07/13/2004 Seroxat PH Drug Use for Unknown Indication Cerebrovascular Accident, Convulsion, Drug Exposure During Pregnancy
F 4167763 4421011 06/29/2004 08/09/2004 Paroxetine PH Depression Cerebrovascular Accident, Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy, Nervous System Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
4169493 4399522 07/16/2004 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
4169493 4415220 03/26/2004 08/04/2004 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
F 4172755 4403570 07/21/2004 Paxil CR CN Panic Disorder Condition Aggravated, Drug Exposure During Pregnancy, Intentional Overdose, Overdose, Panic Reaction, Therapeutic Response Decreased
4177456 4409929 07/28/2004 Paroxetine CN Ill-Defined Disorder Drug Exposure During Pregnancy, Foetal Growth Retardation
F 4181710 4415240 07/14/2004 08/04/2004 Paxil MD Drug Exposure During Pregnancy, Feeding Problem In Newborn, Hypothermia
F 4181710 4426823 07/14/2004 08/16/2004 Paxil MD Drug Exposure During Pregnancy, Feeding Problem In Newborn, Hypothermia
F 4181710 4449933 07/14/2004 09/15/2004 Paxil MD Drug Exposure During Pregnancy, Feeding Problem In Newborn, Hypothermia, Hypothermia Neonatal, Poor Sucking Reflex
F 4184595 4418253 08/09/2004 Paxil CR CN Ill-Defined Disorder Dizziness, Drug Exposure During Pregnancy
F 4184646 4418305 08/09/2004 Paxil CN Anxiety Crying, Depression, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Irritability, Mood Swings
M 4184674 4418334 08/09/2004 Paxil CR CN Ill-Defined Disorder Drug Exposure During Pregnancy, Tremor
F 4184800 4418456 08/09/2004 Paxil CR CN Drug Use for Unknown Indication Dizziness, Drug Exposure During Pregnancy
F 4184997 4418647 12/01/2003 08/09/2004 Paxil CN Ill-Defined Disorder Dizziness, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 4185182 4418832 08/09/2004 Paxil CN Anxiety Weight Increased
F 4185182 4908400 02/10/2006 Paxil CR CN Anxiety Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Malaise, Vomiting, Weight Increased
F 4185588 4419232 08/09/2004 Paxil CN Anxiety Drug Exposure During Pregnancy
F 4185639 4419282 08/09/2004 Paxil CN Ill-Defined Disorder Drug Withdrawal Syndrome
F 4185639 4574567 02/08/2005 Paxil CN Drug Use for Unknown Indication Drug Withdrawal Syndrome
F 4185639 4740024 01/01/2004 08/10/2005 Paxil CN Anxiety Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
F 4185882 4419530 08/09/2004 Paxil CN Ill-Defined Disorder Drug Withdrawal Syndrome
F 4186010 4419659 08/09/2004 Paxil CN Depression Drug Exposure During Pregnancy, Growth Retardation
F 4186011 4419660 08/09/2004 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Headache, Medication Error, Night Sweats
M 4186283 4419958 10/01/2003 08/09/2004 Paroxetine CN Post-Traumatic Stress Disorder Crying, Drug Exposure During Pregnancy, Dyspnoea, Gastrooesophageal Reflux Disease, Hair Plucking, Insomnia
F 4186499 4420227 08/09/2004 Paxil CN Drug Use for Unknown Indication Drug Withdrawal Syndrome
F 4186645 4420388 08/09/2004 Paxil CN Ill-Defined Disorder Drug Exposure During Pregnancy, Feeling Abnormal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 4186885 4420644 08/09/2004 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy
4213357 4455978 09/06/2004 09/22/2004 Paxil PH Hypertonia, Respiratory Acidosis, Respiratory Depression
4213357 4463249 09/06/2004 09/30/2004 Paxil PH Drug Exposure During Pregnancy, Hypotonia, Hypotonia Neonatal, Neonatal Disorder, Neonatal Respiratory Acidosis, Neonatal Respiratory Depression, Premature Baby, Respiratory Acidosis, Respiratory Depression
F 4213357 4489955 09/06/2004 11/01/2004 Paxil PH Drug Exposure During Pregnancy, Hypotonia, Respiratory Acidosis, Respiratory Depression
F 4218467 4462265 08/29/2004 09/29/2004 Paroxetine MD Hyperventilation Drug Exposure During Pregnancy, Dyspnoea, Respiratory Disorder
F 4218468 4462269 08/29/2004 09/29/2004 Paroxetine MD Hyperventilation Drug Exposure During Pregnancy, Dyspnoea, Respiratory Disorder
M 4219264 4463268 06/29/2004 09/30/2004 Paroxetine CN Areflexia, Bradycardia, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Respiratory Depression, Pallor, Restlessness
M 4219264 4466336 06/29/2004 10/05/2004 Paroxetine CN Abnormal Faeces, Bradycardia, Bradycardia Neonatal, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder, Neonatal Respiratory Depression, Pallor, Premature Baby, Restlessness, Tremor, Tremor Neonatal
M 4219267 4463271 09/21/2004 09/30/2004 Paxil MD Affective Disorder Respiratory Depression
M 4219267 4490681 09/21/2004 11/02/2004 Paxil MD Affective Disorder Drug Exposure During Pregnancy, Respiratory Depression, Tremor
M 4219267 4514055 09/21/2004 11/30/2004 Paxil MD Affective Disorder Caesarean Section, Crying, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Hypocalcaemia, Respiratory Depression, Somnolence, Tremor
M 4219267 4526656 09/21/2004 12/14/2004 Paxil MD Affective Disorder Crying, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Hypocalcaemia, Respiratory Depression, Somnolence, Tremor
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 4219271 4463275 06/29/2004 09/30/2004 Paroxetine CN Areflexia, Bradycardia, Bradycardia Neonatal, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Respiratory Depression, Pallor, Restlessness
M 4219271 4466340 06/29/2004 10/05/2004 Paroxetine CN Areflexia, Bradycardia, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Apnoeic Attack, Neonatal Respiratory Depression, Oxygen Saturation Decreased, Pallor, Premature Baby, Restlessness, Unresponsive To Pain Stimuli
F 4220100 4464221 08/04/2004 10/01/2004 Deroxat CN Agitation, Drug Exposure During Pregnancy, High-Pitched Crying, Hypertonia, Respiratory Distress, Somnolence Neonatal, Tachypnoea, Tremor
F 4220100 4554759 08/04/2004 01/18/2005 Deroxat CN Agitation, Apgar Score Low, Apnoeic Attack, Chest X-Ray Abnormal, Drug Exposure During Pregnancy, High-Pitched Crying, Hypertonia, Neonatal Respiratory Distress Syndrome, Respiratory Distress, Somnolence Neonatal, Tachypnoea, Tremor
F 5654406 4488092 03/23/2004 10/28/2004 Paroxetine MD Depression Cytomegalovirus Infection, Drug Exposure During Pregnancy, Intra-Uterine Death
F 5656761 4490682 07/06/2004 11/02/2004 Paxil MD Affective Disorder Abortion Threatened
F 5661746 4496859 10/23/2004 11/09/2004 Paxil MD Asthenia
F 5661746 4510457 10/23/2004 11/24/2004 Paxil MD Asthenia, Drug Exposure During Pregnancy
F 5670527 4477489 10/18/2004 Paxil CN Ill-Defined Disorder Congenital Eye Disorder, Drug Exposure During Pregnancy
M 5671641 4482475 08/27/2004 10/22/2004 Paroxetine CN Drug Use for Unknown Indication Blepharophimosis, Congenital Hyperextension of Spine, Drug Exposure During Pregnancy, Ear Malformation, Facial Dysmorphism, Hypertelorism of Orbit, Hypertonia, Irritability, Neck Deformity
F 5674212 4502320 11/16/2004 03/16/2004 Aropax MD Cerebral Haemorrhage, Cytomegalovirus Infection, Foetal Growth Retardation, Placental Disorder
M 5676753 4504603 06/29/2004 11/18/2004 Seroxat MD Drug Exposure During Pregnancy, Uv Light Therapy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5677772 4505736 11/19/2004 Paxil CN Panic Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Malaise, Premature Labour
F 5677773 4505737 11/19/2004 Paxil CN Panic Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Malaise, Premature Labour
5684264 4512340 11/29/2004 Seroxat MD Drug Use for Unknown Indication Agitation, Drug Exposure During Pregnancy, Respiratory Arrest
M 5692010 4522365 08/29/2004 12/09/2004 Deroxat CN Depression Drug Exposure During Pregnancy, Dyskinesia, Foetal Growth Retardation, Hyperventilation, Hypoxia, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Tremor
F 5696679 4529024 12/16/2004 Seroxat LW Completed Suicide, Emotional Disorder, Ill-Defined Disorder
F 5696679 4647834 01/01/2001 04/28/2005 Paroxetine MD Anger, Disturbance In Attention, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hallucination (Auditory), Ill-Defined Disorder, Intentional Misuse, Irritability, Loss of Libido, Memory Impairment, Obsessive-Compulsive Disorder, Overdose, Panic Attack, Polydipsia, Suicidal Ideation
F 5696679 5088731 01/01/2001 08/25/2006 Seroxat MD Anger, Anxiety, Depression, Disturbance In Attention, Drug Withdrawal Syndrome, Hallucination (Auditory), Ill-Defined Disorder, Intentional Overdose, Irritability, Loss of Libido, Memory Impairment, Obsessive-Compulsive Disorder, Overdose, Panic Attack, Polydipsia, Suicidal Ideation
F 5696679 5088790 01/01/2001 08/25/2006 Seroxat MD Anger, Disturbance In Attention, Hallucination (Auditory), Ill-Defined Disorder, Intentional Overdose, Irritability, Loss of Libido, Memory Impairment, Obsessive-Compulsive Disorder, Panic Attack, Polydipsia, Suicidal Ideation
F 5696679 5108122 01/01/2001 09/19/2006 Seroxat MD Anger, Disturbance In Attention, Hallucination (Auditory), Ill-Defined Disorder, Intentional Overdose, Irritability, Loss of Libido, Memory Impairment, Obsessive-Compulsive Disorder, Panic Attack, Polydipsia, Suicidal Ideation
F 5696706 4529051 12/16/2004 Seroxat LW Completed Suicide, Emotional Disorder, Ill-Defined Disorder
F 5696706 4807101 01/01/2002 10/24/2005 Seroxat MD Depression Caesarean Section, Completed Suicide, Crying, Depressed Mood, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Emotional Disorder, Ill-Defined Disorder, Overdose
F 5696706 5230612 01/01/2002 02/06/2007 Seroxat MD Depression Completed Suicide, Crying, Depressed Mood, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Emotional Disorder, Overdose
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5696707 4529052 12/16/2004 Seroxat LW Completed Suicide, Emotional Disorder, Ill-Defined Disorder
F 5696707 4744834 01/01/2001 08/15/2005 Seroxat MD Abortion, Anxiety, Drug Withdrawal Syndrome, Emotional Disorder, Hypomania, Insomnia, Intentional Misuse, Mood Swings, Psychomotor Hyperactivity, Suicidal Ideation, Weight Increased
F 5696735 4529080 12/16/2004 Seroxat LW Completed Suicide, Emotional Disorder, Ill-Defined Disorder
F 5696735 4744836 08/15/2005 Seroxat MD Abortion Induced, Apathy, Appetite Disorder, Completed Suicide, Emotional Distress, Ill-Defined Disorder, Irritability, Overdose, Tearfulness, Weight Fluctuation
F 5696735 5230635 02/06/2007 Seroxat MD Abortion Induced, Apathy, Appetite Disorder, Completed Suicide, Drug Withdrawal Syndrome, Emotional Distress, Irritability, Overdose, Tearfulness, Weight Fluctuation
F 5696819 4529173 12/16/2004 Seroxat LW Completed Suicide, Emotional Disorder, Ill-Defined Disorder
F 5696819 4646722 11/01/2001 04/27/2005 Seroxat MD Abortion Spontaneous, Drug Exposure During Pregnancy, Drug Intolerance, Ill-Defined Disorder, Overdose, Suicide Attempt
F 5696819 5230741 11/01/2001 02/06/2007 Seroxat MD Abortion Spontaneous, Drug Withdrawal Syndrome, Overdose, Suicide Attempt
F 5696929 4529287 12/16/2004 Seroxat LW Completed Suicide, Emotional Disorder, Ill-Defined Disorder
F 5696929 4668964 05/31/2002 05/23/2005 Paroxetine MD Abortion Induced, Decreased Interest, Depressed Mood, Depression, Disability, Disturbance In Attention, Ill-Defined Disorder, Intentional Self-Injury, Suicidal Ideation
F 5696929 5230897 05/31/2002 02/06/2007 Seroxat MD Depression Abortion Induced, Decreased Interest, Depressed Mood, Depression, Disability, Disturbance In Attention, Drug Withdrawal Syndrome, Intentional Self-Injury, Suicidal Ideation
F 5696929 5585537 05/31/2002 01/09/2008 Seroxat MD Depression Abortion Induced, Anxiety, Decreased Interest, Depressed Mood, Depression, Disability, Disturbance In Attention, Dizziness, Drug Withdrawal Syndrome, Headache, Insomnia, Intentional Self-Injury, Mood Swings, Suicidal Ideation, Visual Disturbance
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5697011 4529460 12/16/2004 Seroxat LW Completed Suicide, Emotional Disorder, Ill-Defined Disorder
F 5697011 4725960 01/01/1997 07/27/2005 Seroxat MD Depression Completed Suicide, Condition Aggravated, Drug Exposure During Pregnancy, Ill-Defined Disorder, Insomnia, Overdose
F 5697011 5230679 01/01/1997 02/06/2007 Seroxat MD Depression Completed Suicide, Condition Aggravated, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Insomnia, Overdose
5707528 4543624 01/03/2005 Seroxat MD Ill-Defined Disorder Drug Exposure During Pregnancy, Kidney Malformation, Urinary Tract Malformation
F 5709805 4541047 12/28/2004 Paxil Caesarean Section, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Gene Mutation Identification Test Positive, Hypoglycaemia Neonatal, Hypotonia Neonatal, Loose Stools, Meconium In Amniotic Fluid, Muscle Rigidity, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Serum Serotonin Increased, Tremor Neonatal
M 5711906 4543962 01/03/2005 Paroxetine MD Cerebral Atrophy Congenital, Cerebral Ventricle Dilatation, Congenital Neurological Disorder, Drug Exposure During Pregnancy, Epilepsy Congenital, Eye Movement Disorder, Fontanelle Bulging, Hypotonia Neonatal, Intraventricular Haemorrhage Neonatal, Lethargy, Neonatal Apnoeic Attack, Neonatal Disorder, Serum Serotonin Decreased, Stereotypic Movement Disorder, Visual Evoked Potentials Abnormal
F 5717961 4556050 12/27/2004 01/19/2005 Deroxat CN Drug Exposure During Pregnancy, Hypotonia, Hypotonia Neonatal, Neonatal Apnoeic Attack
F 5717961 4608834 12/27/2004 03/15/2005 Deroxat CN Drug Exposure During Pregnancy, Hypotonia, Hypotonia Neonatal, Hypoventilation, Hypoventilation Neonatal, Neonatal Apnoeic Attack
M 5718981 4557063 01/20/2005 Paxil CN Generalised Anxiety Disorder Autism, Drug Exposure During Pregnancy
5721077 4559543 01/01/2005 01/24/2005 Seroxat MD Congenital Bladder Anomaly, Drug Exposure During Pregnancy, Gastrointestinal Disorder Congenital, Gastrointestinal Motility Disorder
5721077 4562813 11/05/2004 01/27/2005 Seroxat MD Congenital Bladder Anomaly, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Gastrointestinal Disorder Congenital, Gastrointestinal Malformation, Gastrointestinal Motility Disorder
5721077 4617849 11/05/2004 03/24/2005 Paroxetine MD Congenital Bladder Anomaly, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Gastrointestinal Disorder Congenital, Gastrointestinal Malformation, Gastrointestinal Motility Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
5722373 4555636 01/18/2005 Paroxetine MD Drug Exposure During Pregnancy, Kidney Malformation, Renal Agenesis, Ultrasound Antenatal Screen Abnormal, Urinary Tract Malformation
5722373 4562770 01/21/2005 Paroxetine MD Congenital Anomaly, Drug Exposure During Pregnancy, Kidney Malformation, Single Functional Kidney, Urinary Tract Malformation
5722373 4562899 01/21/2005 Paroxetine MD Congenital Genitourinary Abnormality, Drug Exposure During Pregnancy, Kidney Malformation, Single Functional Kidney, Urinary Tract Malformation
F 5728405 4568289 01/01/2005 02/02/2005 Paxil CN Drug Use for Unknown Indication Abortion Spontaneous
F 5728413 4568300 12/20/2004 02/02/2005 Deroxat CN Ill-Defined Disorder Cardiomyopathy, Drug Exposure During Pregnancy, Ductus Arteriosus Premature Closure, Hypoxia, Pyelocaliectasis, Respiratory Distress, Ureteric Dilatation, Ventricular Hypertrophy, Ventricular Hypokinesia
F 5731951 4573189 02/08/2005 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
5731952 4573190 02/08/2005 Paxil CN Drug Use for Unknown Indication Dependence, Drug Exposure During Pregnancy
F 5732265 4573505 02/08/2005 Paxil CN Drug Use for Unknown Indication Anxiety, Drug Exposure During Pregnancy
F 5732328 4573567 02/08/2005 Paroxetine CN Panic Disorder Drug Exposure During Pregnancy, Panic Attack
F 5732332 4573571 02/08/2005 Paxil CN Anxiety Dependence, Dizziness, Drug Withdrawal Syndrome, Nausea, Paraesthesia, Tremor
5733061 4574604 02/08/2005 Paxil CN Convulsion, Drug Exposure During Pregnancy
F 5733153 4574704 06/09/2004 02/08/2005 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Menstrual Disorder, Menstruation Irregular
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5737099 4580234 01/01/2005 02/14/2005 Paxil OT Depression Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Pneumothorax
M 5742120 4587263 02/18/2005 Paroxetine CN Depression Anomaly of External Ear Congenital, Cataract, Chondrodystrophy, Congenital Musculoskeletal Anomaly, Cyanosis, Drug Exposure During Pregnancy, Facial Dysmorphism, Neck Deformity, Respiratory Arrest
F 5742122 4587265 02/18/2005 Aropax MD Drug Exposure During Pregnancy, Drug Interaction, Treatment Noncompliance
F 5751015 4598257 01/01/2003 03/04/2005 Paxil CN Anxiety Asthenia, Dizziness, Drug Exposure During Pregnancy, Gait Disturbance, Loss of Consciousness, Sleep Disorder
F 5759385 4610064 02/28/2005 03/16/2005 Paxil MD Affective Disorder Bradykinesia, Drug Exposure During Pregnancy, Eating Disorder
F 5759385 4626354 02/28/2005 04/04/2005 Paxil MD Bradykinesia, Eating Disorder
M 5767845 4622852 03/30/2005 Paxil MD Panic Disorder Drug Exposure During Pregnancy, Jaundice Neonatal
M 5768571 4624177 02/19/2005 03/31/2005 Deroxat CN Cerebral Haemorrhage, Drug Exposure During Pregnancy, Epilepsy, Hypotonia, Sleep Apnoea Syndrome, Subdural Haematoma
F 5769835 4626366 04/04/2005 Paroxetine CN Abortion Induced, Drug Exposure During Pregnancy
M 5770385 4627133 01/01/2001 04/05/2005 Paxil CN Congenital Absence of Bile Ducts, Drug Exposure During Pregnancy
F 5774750 4634085 04/13/2005 Paxil CR CN Abortion Spontaneous, Drug Exposure During Pregnancy
M 5777871 4638965 12/13/2004 04/19/2005 Paroxetine CN Drug Exposure During Pregnancy, Feeding Problem In Newborn
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5781777 4644176 04/01/2005 04/25/2005 Paroxetine MD Conjunctival Haemorrhage, Dermatitis Diaper, Diarrhoea Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Exanthem, Hypokinesia, Oblique Presentation, Oligodipsia, Polycythaemia, Somnolence Neonatal, Vomiting Neonatal, Weight Decreased
F 5787633 4651837 05/04/2005 Paxil CR CN Congenital Anomaly, Drug Exposure During Pregnancy
M 5787633 4682631 01/01/2005 06/06/2005 Paxil CR CN Congenital Anomaly, Congenital Ureteric Anomaly, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hydronephrosis, Kidney Malformation
5794176 4660471 05/12/2005 Paroxetine OT Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Tremor
F 5797228 4663541 05/17/2005 Paroxetine LW Completed Suicide, Ill-Defined Disorder
F 5797228 4766019 01/01/1999 09/12/2005 Seroxat MD Depression Abortion Induced, Completed Suicide, Depressed Mood, Drug Withdrawal Syndrome, Hyperhidrosis, Mood Swings, Somnolence, Suicidal Ideation, Weight Increased
F 5797228 5589674 01/01/1999 01/14/2008 Seroxat MD Depression Abortion Induced, Aggression, Agitation, Amnesia, Anxiety, Confusional State, Depressed Mood, Depression, Diarrhoea, Dizziness, Fatigue, Hyperhidrosis, Lethargy, Mood Swings, Nausea, Nightmare, Sleep Disorder, Somnolence, Suicidal Ideation, Tremor, Weight Increased, Withdrawal Syndrome
F 5801937 4668968 01/01/2004 05/23/2005 Paroxetine MD Abortion Induced, Asthenia, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Abnormal, Hyperemesis Gravidarum, Malaise
5810793 4680037 06/02/2005 Paroxetine CN Drug Exposure During Pregnancy, Drug Level Changed, Dyskinesia, Hypertonia, Opisthotonus
F 5814227 4685399 06/08/2005 Deroxat CN Abortion Induced, Congenital Nose Malformation, Drug Exposure During Pregnancy, Facial Dysmorphism, Micrognathia, Multiple Congenital Abnormalities, Oesophageal Atresia, Retrognathia
F 5815063 4679396 05/31/2005 Paxil MD Abortion Spontaneous, Agitation, Anorexia, Anxiety, Apathy, Contusion, Depressed Mood, Depression, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome, Dysphagia, Dyspnoea, Economic Problem, Feeling Abnormal, Flushing, Food Craving, Heart Rate Increased, Hyperventilation, Insomnia, Lethargy, Nausea, Night Sweats, Panic Attack, Paraesthesia, Restlessness, Suicidal Ideation, Tearfulness
F 5815063 5589645 10/01/2001 01/14/2008 Paroxetine MD Abortion Spontaneous, Agitation, Anxiety, Apathy, Confusional State, Decreased Appetite, Depressed Mood, Depression, Dizziness, Dysphagia, Dyspnoea, Flushing, Heart Rate Increased, Hyperventilation, Insomnia, Nausea, Night Sweats, Nightmare, Panic Attack, Paraesthesia, Restlessness, Sleep Disorder, Suicidal Ideation, Tearfulness, Withdrawal Syndrome
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5816453 4687912 06/10/2005 Paxil CN Stillbirth
5817453 4688819 06/13/2005 Paxil CN Ventricular Septal Defect
5819180 4690656 02/24/2005 06/15/2005 02/24/2005 Deroxat CN Drug Exposure During Pregnancy, Intra-Uterine Death
5820565 4692727 01/01/2005 06/17/2005 05/10/2005 Paxil CR CN Drug Exposure During Pregnancy, Foetal Growth Retardation
F 5820930 4693288 06/17/2005 Seroxat MD Abortion Induced, Drug Exposure During Pregnancy
F 5820930 4879772 01/13/2006 Seroxat MD Drug Use for Unknown Indication Drug Exposure Before Pregnancy
5824757 4690908 06/10/2005 Paroxetine Antidepressant Drug Level Increased, Drug Exposure During Pregnancy, Hypertonia Neonatal
F 5825255 4699310 10/01/2001 06/24/2005 Paroxetine MD Abortion Spontaneous, Agitation, Anxiety, Apathy, Decreased Appetite, Depressed Mood, Depression, Drug Withdrawal Syndrome, Dysphagia, Dyspnoea, Flushing, Heart Rate Increased, Hyperventilation, Nausea, Night Sweats, Panic Attack, Paraesthesia, Restlessness, Sleep Disorder, Suicidal Ideation, Tearfulness
M 5825264 4699327 06/24/2005 Paroxetine CN Drug Exposure During Pregnancy, Feeding Problem In Newborn, Hypoglycaemia, Hypoglycaemia Neonatal, Hypotonia, Hypotonia Neonatal, Lethargy, Motor Dysfunction, Respiratory Depth Decreased
F 5829517 4705389 06/27/2005 07/01/2005 Paxil CN Abortion Induced, Drug Exposure During Pregnancy, Laboratory Test Abnormal
5829518 4705390 06/27/2005 07/01/2005 06/27/2005 Paxil CN Amniotic Fluid Volume Decreased, Congenital Genitourinary Abnormality, Drug Exposure During Pregnancy, Renal Cyst
F 5829518 4735618 06/27/2005 08/05/2005 06/27/2005 Paxil CN Generalised Anxiety Disorder Abortion Induced, Amniotic Fluid Volume Decreased, Congenital Genitourinary Abnormality, Drug Exposure During Pregnancy, Renal Cyst
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5829521 4705393 06/29/2005 07/01/2005 Paroxetine CN Depression Drug Exposure During Pregnancy, Limb Malformation, Pharmaceutical Product Complaint
M 5829521 4710839 06/29/2005 07/11/2005 Paroxetine CN Depression Congenital Anomaly, Drug Exposure During Pregnancy, Limb Malformation, Pharmaceutical Product Complaint
M 5829521 4715985 06/29/2005 07/18/2005 Paroxetine CN Depression Limb Malformation, Pharmaceutical Product Complaint
F 5830390 4706464 02/11/2005 07/05/2005 Deroxat MD Panic Reaction Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Foetal Arrhythmia, Premature Baby
F 5831568 4707493 07/06/2005 Seroxat LW Aggression, Completed Suicide, Ill-Defined Disorder
F 5831568 5231061 05/01/2000 02/06/2007 Seroxat MD Aggression, Completed Suicide, Depression, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Poor Quality Sleep, Suicidal Ideation, Tearfulness
M 5835831 4707599 07/05/2005 Paroxetine Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hypoglycaemia Neonatal, Hypotonia Neonatal, Lethargy, Motor Dysfunction, Neonatal Disorder, Poor Sucking Reflex, Respiratory Disorder Neonatal
M 5835831 4766208 09/09/2005 Paxil Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hypoglycaemia Neonatal, Hypotonia Neonatal, Lethargy, Neonatal Disorder, Poor Sucking Reflex, Respiratory Disorder Neonatal
5838037 4715168 12/07/2004 07/15/2005 06/23/2005 Paroxetine CN Drug Use for Unknown Indication Death Neonatal, Drug Exposure During Pregnancy
M 5841906 4720735 07/14/2005 07/21/2005 Paxil MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
M 5841906 4725976 07/14/2005 07/27/2005 Paxil MD Caesarean Section, Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Jittery, Moaning, Somnolence, Tachypnoea
M 5841906 4762616 07/14/2005 09/07/2005 Paxil MD Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Jittery, Moaning, Somnolence, Tachypnoea
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5841906 4770833 07/14/2005 09/15/2005 Paxil MD Caesarean Section, Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeding Disorder Neonatal, Feeling Jittery, Moaning, Somnolence, Somnolence Neonatal, Tachypnoea
F 5844690 4723460 07/25/2005 Paxil CN Depression Anaemia, Drug Exposure During Pregnancy, Initial Insomnia, Overdose, Somnolence
M 5845596 4724769 07/17/2005 07/26/2005 Paxil MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
M 5845596 4742826 07/17/2005 08/11/2005 Paxil MD Cardiac Murmur, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Nausea, Oxygen Saturation Decreased, Persistent Foetal Circulation, Tremor
M 5845596 4794270 07/17/2005 10/11/2005 Paxil MD Cardiac Murmur, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Nausea, Oxygen Saturation Decreased, Persistent Foetal Circulation, Tremor
M 5851004 4732546 01/01/2005 08/03/2005 Deroxat MD Anotia, Aplasia, Drug Exposure During Pregnancy, Ear Malformation
M 5853915 4736891 05/01/2005 08/08/2005 Deroxat CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hyperbilirubinaemia, Hypertonia, Hypotonia, Insomnia, Poor Weight Gain Neonatal, Tension, Vomiting
F 5855642 4739132 01/01/2005 08/10/2005 Paxil CR MD Anxiety Disorder Blood Cholesterol Increased, Drug Exposure During Pregnancy
F 5855819 4739310 08/10/2005 Paxil CN Drug Use for Unknown Indication Dizziness, Drug Exposure During Pregnancy, Sensory Disturbance
5855866 4739356 08/10/2005 Paxil LW Drug Use for Unknown Indication Drug Withdrawal Syndrome
F 5855866 4904113 12/01/1993 02/08/2006 Paxil LW Depression Abortion Induced, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
5855952 4739442 01/26/2005 08/10/2005 Paxil CN Depression Drug Exposure During Pregnancy, Premature Baby
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5855995 4739457 08/10/2005 Paxil CN Depression Drug Exposure During Pregnancy, Mental Impairment, Pain
F 5856397 4739861 08/10/2005 Paxil CN Drug Use for Unknown Indication Abnormal Dreams, Agitation, Dizziness, Drug Exposure During Pregnancy, Fatigue
5857070 4740971 08/10/2005 Paxil CN Depression Drug Exposure During Pregnancy, Premature Labour
5857075 4740976 05/01/2005 08/10/2005 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Tremor
F 5857208 4741160 08/10/2005 Paxil LW Drug Use for Unknown Indication Drug Withdrawal Syndrome
F 5857208 4904101 05/24/2002 02/08/2006 Paxil LW Anxiety Abortion Spontaneous, Drug Withdrawal Syndrome
5857328 4741282 08/10/2005 Paxil CN Drug Use for Unknown Indication Convulsion, Drug Exposure During Pregnancy
F 5857340 4741296 11/13/2004 08/10/2005 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy
F 5857945 4742215 08/11/2005 Paxil CR CN Panic Disorder Anxiety, Fatigue
F 5857945 4908417 03/01/2005 02/10/2006 Paxil CR CN Panic Disorder Anxiety, Drug Exposure During Pregnancy, Fatigue
F 5859359 4686229 06/09/2005 Paxil CN Apgar Score Low, Drug Exposure During Pregnancy
M 5866751 4752340 01/27/2005 08/25/2005 Paroxetine CN Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Polyhydramnios, Poor Sucking Reflex
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
5877725 4768719 10/22/2003 09/14/2005 Paxil CR CN Depression Drug Exposure During Pregnancy, Heart Disease Congenital
5879891 4766219 06/18/2001 09/09/2005 Paxil Brain Scan Abnormal, Cerebral Atrophy, Cerebral Haematoma, Cerebral Haemorrhage Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy, Eye Movement Disorder, Fontanelle Bulging, Hypotonia Neonatal, Intracranial Pressure Increased, Intraventricular Haemorrhage Neonatal, Lethargy, Moaning, Movement Disorder, Neonatal Apnoeic Attack, Neonatal Disorder, Nervous System Disorder, Pupils Unequal, Respiratory Disorder, Ventricular Hypertrophy, Vomiting Neonatal
M 5879897 4766222 09/09/2005 Paxil Agitation Neonatal, Bradycardia Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Small for Dates Baby, Vomiting Neonatal
F 5879898 4766223 09/09/2005 Paxil Drug Exposure During Pregnancy, Intraventricular Haemorrhage Neonatal, Nervous System Disorder, Premature Baby, Subarachnoid Haemorrhage Neonatal
5879943 4766541 09/09/2005 Paxil Drug Dispensing Error, Drug Exposure During Pregnancy, Drug Interaction, Drug Withdrawal Syndrome Neonatal, Eye Movement Disorder, Feeding Disorder Neonatal, Feeling Jittery, Haematochezia, Hypothermia Neonatal, Irritability, Lethargy, Myoclonus, Necrotising Enterocolitis Neonatal, Neonatal Disorder, Pneumatosis Intestinalis, Somnolence
F 5879945 4766542 09/09/2005 Paxil Apgar Score Low, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypoglycaemia Neonatal, Hypotonia Neonatal, Irritability, Lethargy, Leukopenia Neonatal, Necrotising Enterocolitis Neonatal, Pneumatosis Intestinalis, Thrombocytopenia Neonatal, Vomiting Neonatal
M 5879946 4766543 09/09/2005 Paxil Chills, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hyperreflexia, Hypertonia Neonatal, Neonatal Disorder, Transient Tachypnoea of the Newborn
5879949 4766544 09/09/2005 Paxil Agitation Neonatal, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypoglycaemia Neonatal, Hyporeflexia, Hypotonia Neonatal, Lethargy
F 5882177 4773828 09/20/2005 Seroxat PH Drug Exposure During Pregnancy, Premature Baby
M 5886102 4779948 09/27/2005 Paroxetine MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Hypospadias
M 5886102 4804398 10/20/2005 Paroxetine MD Depression Drug Exposure During Pregnancy, Hypospadias
M 5886605 4778441 09/07/2005 09/23/2005 Paxil MD Depression Congenital Anomaly, Drug Exposure During Pregnancy, Hypospadias
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5889834 4785552 10/03/2005 Paxil CN Drug Use for Unknown Indication Abortion Spontaneous
M 5889836 4785554 10/03/2005 Paxil CN Depression Abnormal Behaviour, Apraxia, Drug Exposure During Pregnancy, Speech Disorder
F 5889837 4785555 10/03/2005 Paxil CN Drug Use for Unknown Indication Cardiac Disorder, Drug Exposure During Pregnancy, Heart Disease Congenital
5889850 4785588 10/03/2005 Deroxat MD Deformity Thorax, Drug Exposure During Pregnancy, Limb Malformation
5890618 4787003 10/04/2005 Seroxat MD Obsessive-Compulsive Disorder Atrial Septal Defect, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Sedation
F 5891476 4784378 07/13/2001 09/29/2005 07/13/2001 Paxil OT Depression Drug Exposure During Pregnancy, Placental Disorder, Small for Dates Baby, Stillbirth
5891649 4788620 10/05/2005 Paxil CN Drug Use for Unknown Indication Cardiovascular Disorder, Drug Exposure During Pregnancy, Hydrocephalus
F 5892354 4789790 10/06/2005 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Intra-Uterine Death, Placental Disorder, Umbilical Cord Abnormality, Umbilical Cord Vascular Disorder
M 5892400 4786675 08/19/1998 10/03/2005 Paxil CN Depression, Drug Withdrawal Syndrome Craniosynostosis, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyspnoea, Hyperacusis, Infantile Apnoeic Attack, Irritability, Neonatal Disorder, Pierre Robin Syndrome
M 5898843 4804436 01/01/2004 10/20/2005 Seroxat CN Drug Use for Unknown Indication Convulsion, Convulsion Neonatal, Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Eating Disorder, Ill-Defined Disorder, Learning Disability, Muscle Twitching, Neonatal Disorder, Retrognathia, Small for Dates Baby
F 5898845 4797300 10/13/2005 Seroxat CN Depression Anxiety, Chills, Cleft Palate, Congenital Anomaly, Drug Exposure During Pregnancy, Dyspnoea, Fatigue, Fear, Feeling Cold, Heart Disease Congenital, Hyperhidrosis, Insomnia, Pain, Palpitations, Self-Injurious Ideation, Sensory Disturbance, Suicidal Ideation
F 5898846 4797302 10/13/2005 Seroxat CN Cardiac Disorder, Cleft Palate, Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Hereditary Disorder, Palatal Disorder, Small for Dates Baby, Speech Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5901343 4795627 03/02/2001 10/07/2005 Paxil OT Anxiety, Depression, Post-Traumatic Stress Disorder Abortion Spontaneous, Blood Human Chorionic Gonadotropin Increased, Developmental Delay, Drug Exposure During Pregnancy, Thanatophoric Dwarfism
F 5902144 4800118 10/13/2005 10/17/2005 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Epilepsy
F 5902151 4800131 10/17/2005 Paroxetine CN Depression Convulsion, Drug Exposure During Pregnancy, Dyskinesia, Feeling Jittery, Hyperreflexia, Hypertonia Neonatal, Hypotonia, Infection, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Neonatal Tachycardia, Opisthotonus, Polycythaemia, Posturing, Psychomotor Hyperactivity, Pyrexia, Tremor
M 5903393 4801700 10/12/2005 10/18/2005 Paxil MD Drug Exposure During Pregnancy, Neonatal Asphyxia, Somnolence Neonatal
M 5903393 4820627 10/12/2005 11/04/2005 Paxil MD Drug Exposure During Pregnancy, Neonatal Asphyxia, Somnolence Neonatal
M 5903393 4842603 10/12/2005 12/01/2005 Paxil MD Drug Exposure During Pregnancy, Neonatal Asphyxia, Somnolence Neonatal
M 5903945 4810249 10/26/2005 Paroxetine CN Alpha Haemolytic Streptococcal Infection, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Foetal Distress Syndrome, Hypertonia, Hypoglycaemia, Inappropriate Antidiuretic Hormone Secretion, Opisthotonus, Salivary Hypersecretion
5906126 4805992 10/21/2005 Paxil OT Drug Use for Unknown Indication Drug Exposure During Pregnancy, Foetal Malformation
F 5907119 4807120 10/24/2005 Paxil MD Depression Antepartum Haemorrhage
M 5907462 4802122 02/08/2005 10/12/2005 Paroxetine Social Phobia Congenital Aortic Stenosis, Drug Exposure During Pregnancy
F 5907905 4808560 10/25/2005 Paxil CN Drug Use for Unknown Indication Abortion Spontaneous, Drug Exposure During Pregnancy
F 5907905 4819181 11/03/2005 Paxil CN Drug Use for Unknown Indication Abortion Spontaneous, Libido Decreased
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5915072 4815461 08/01/2005 10/28/2005 Paxil CN Post-Traumatic Stress Disorder Drug Exposure During Pregnancy, Suicide Attempt
F 5915416 4816997 01/01/2000 11/01/2005 Paxil CN Drug Use for Unknown Indication Abortion Spontaneous, Drug Exposure During Pregnancy
M 5916840 4819182 03/19/2005 11/03/2005 Paxil CN Depression Cleft Palate, Crying, Drug Exposure During Pregnancy, Insomnia
F 5916862 4819210 06/07/2005 11/03/2005 Deroxat CN Drug Exposure During Pregnancy, Hypercalcaemia, Premature Baby
5921221 4825796 09/25/2004 11/11/2005 Deroxat CN Obsessive-Compulsive Disorder Drug Exposure During Pregnancy, Hypoxia, Intra-Uterine Death
F 5922008 4827112 11/14/2005 Paroxetine CN Convulsion, Decreased Appetite, Drug Exposure During Pregnancy, Dyskinesia, Feeling Jittery, Hyperreflexia, Hypertonia, Intercostal Retraction, Opisthotonus, Polycythaemia, Pyrexia, Respiratory Distress, Serotonin Syndrome, Tachypnoea, Tremor
F 5926139 4832892 11/21/2005 Paroxetine CN Convulsion, Drug Exposure During Pregnancy, Dyskinesia, Dyskinesia Neonatal, Hyperexplexia, Hyperreflexia, Hypertonia, Hypertonia Neonatal, Neonatal Disorder, Opisthotonus, Posture Abnormal, Pyrexia, Respiratory Distress, Serotonin Syndrome, Tachypnoea
F 5932313 4841333 11/20/2005 11/30/2005 Paxil MD Panic Disorder Caesarean Section, Drug Exposure During Pregnancy, Premature Labour
M 5932314 4841334 11/20/2005 11/30/2005 Paxil MD Caesarean Section, Drug Exposure During Pregnancy, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby
M 5932314 4845323 11/20/2005 12/05/2005 Paxil MD Drug Exposure During Pregnancy, Dyspepsia, Gastrointestinal Hypomotility, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby, Tachypnoea
M 5932314 4865205 11/20/2005 12/23/2005 Paxil MD Drug Exposure During Pregnancy, Dyspepsia, Gastrointestinal Hypomotility, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby, Respiratory Disorder, Tachypnoea
M 5932315 4841335 11/20/2005 11/30/2005 Paxil MD Caesarean Section, Drug Exposure During Pregnancy, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5932315 4845324 11/20/2005 12/05/2005 Paxil MD Drug Exposure During Pregnancy, Dyspepsia, Gastrointestinal Hypomotility, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby, Tachypnoea
M 5932315 4865206 11/20/2005 12/23/2005 Paxil MD Drug Exposure During Pregnancy, Dyspepsia, Gastrointestinal Hypomotility, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby, Respiratory Disorder, Tachypnoea
5933590 4842608 11/08/2005 12/01/2005 Paxil MD Drug Exposure During Pregnancy, Irritability, Respiratory Disorder Neonatal
5933590 4852204 11/08/2005 12/13/2005 Paxil MD Drug Exposure During Pregnancy, Irritability, Respiratory Disorder Neonatal
5933590 5123844 11/08/2005 10/10/2006 Paxil MD Drug Exposure During Pregnancy, Irritability, Respiratory Disorder Neonatal
F 5934236 4835936 11/18/2005 Paroxetine Convulsion Neonatal, Drug Exposure During Pregnancy, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Polycythaemia, Pyrexia, Serotonin Syndrome
M 5935180 4848424 01/01/2005 12/08/2005 Paxil CR OT Depression Adrenal Insufficiency, Arnold-Chiari Malformation, Drug Exposure During Pregnancy, Premature Baby
M 5935180 4976755 01/01/2005 04/19/2006 Paxil CR OT Depression Adrenal Insufficiency, Adrenogenital Syndrome, Arnold-Chiari Malformation, Developmental Delay, Drug Exposure During Pregnancy, Premature Baby
M 5935180 5046427 01/01/2005 07/10/2006 Paxil CR OT Depression Adrenal Insufficiency, Adrenogenital Syndrome, Arnold-Chiari Malformation, Developmental Delay, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus, Premature Baby
M 5935180 5094238 01/01/2005 08/31/2006 Paxil CR OT Depression Adrenal Insufficiency, Adrenogenital Syndrome, Arnold-Chiari Malformation, Developmental Delay, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus, Premature Baby
M 5935180 5416700 01/01/2005 08/16/2007 Paxil CR OT Depression Adrenal Insufficiency, Adrenogenital Syndrome, Arnold-Chiari Malformation, Developmental Delay, Drug Exposure During Pregnancy, Premature Baby, Speech Disorder Developmental
F 5935634 4845301 12/05/2005 Paxil CR MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Talipes
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5935634 4862525 01/01/2005 12/21/2005 Paxil CR MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Talipes
M 5938624 4849128 01/01/2005 12/09/2005 Paroxetine CN Depression Drug Exposure During Pregnancy, Spina Bifida
5940332 4844691 11/28/2005 Paroxetine Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeding Disorder of Infancy or Early Childhood, Irritability, Lethargy
F 5940816 4861090 12/20/2005 Paroxetine CN Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Grand Mal Convulsion, Hyperreflexia, Hypertonia, Neonatal Respiratory Distress Syndrome, Opisthotonus, Polycythaemia, Psychomotor Hyperactivity, Pyrexia, Serotonin Syndrome, Tremor
F 5940816 4879784 01/13/2006 Paroxetine CN Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Hyperreflexia, Hypertonia Neonatal, Neonatal Respiratory Distress Syndrome, Opisthotonus, Polycythaemia, Psychomotor Hyperactivity, Pyrexia, Serotonin Syndrome, Tonic Clonic Movements, Tremor
M 5941076 4853296 01/01/2004 12/14/2005 Paxil CN Depression Aortic Valve Disease, Atrial Septal Defect, Bicuspid Aortic Valve, Coarctation of the Aorta, Drug Exposure During Pregnancy, Mitral Valve Disease, Mitral Valve Incompetence, Ventricular Septal Defect
5941078 4853298 12/14/2005 Paxil CR CN Drug Use for Unknown Indication Cardiac Septal Defect, Drug Exposure During Pregnancy
F 5941103 4853331 12/14/2005 Seroxat MD Abortion Spontaneous, Drug Withdrawal Syndrome
F 5942077 4854740 01/01/2005 12/15/2005 Paxil CN Drug Use for Unknown Indication Abortion Spontaneous, Amniotic Cavity Disorder, Drug Exposure During Pregnancy, Vaginal Haemorrhage
M 5942742 4855914 03/13/2005 12/16/2005 Paxil MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal, Neonatal Disorder
M 5942742 4871797 03/13/2005 01/04/2006 Paxil MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal, Neonatal Disorder
M 5947443 4861076 12/20/2005 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Spina Bifida Occulta, Spinal Cord Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5947927 4852087 12/12/2005 01/19/2002 Paxil Depression Death Neonatal, Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome
M 5948306 4862536 02/01/2005 12/21/2005 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Trisomy 21
M 5949540 4864097 12/22/2005 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
M 5949540 5463162 09/20/2007 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
5949551 4864110 05/06/2004 12/22/2005 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Meningitis, Respiratory Failure
5949571 4864146 12/22/2005 Paxil MD Drug Exposure During Pregnancy, Foetal Growth Retardation
F 5950498 4854241 12/01/2004 12/13/2005 Paxil OT Postpartum Depression Apathy, Balance Disorder, Chest Discomfort, Chest Pain, Disturbance In Attention, Drug Withdrawal Syndrome, Dyspnoea, Feeling Abnormal, Hypersomnia, Influenza Like Illness, Malaise, Muscular Weakness, Orthostatic Hypotension, Pain, Palpitations, Postpartum Depression, Stress, Weight Increased
M 5950935 4855808 01/20/2003 12/15/2005 Paxil CN Social Phobia Drug Exposure During Pregnancy, Fallot's Tetralogy
5952665 4868407 07/12/2005 12/29/2005 Paxil MD Congenital Vitreous Anomaly, Drug Exposure During Pregnancy
5952665 5099718 07/12/2005 09/08/2006 Paxil MD Mental Disorder Congenital Vitreous Anomaly, Drug Exposure During Pregnancy
5952665 5232537 07/12/2005 02/07/2007 Paxil MD Post-Traumatic Stress Disorder Congenital Vitreous Anomaly, Drug Exposure During Pregnancy
F 5954787 4871790 01/04/2006 Paxil CR CN Depression Chromosome Abnormality, Congenital Anomaly, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5955621 4873131 01/05/2006 Paxil CR PH Drug Use for Unknown Indication Drug Exposure During Pregnancy, Spina Bifida
5958515 4877573 01/11/2006 Paroxetine CN Depression Atrioventricular Septal Defect, Congenital Hypoparathyroidism, Congenital Musculoskeletal Anomaly, Congenital Thymus Absence, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Heart Rate Increased, Interruption of Aortic Arch, Neonatal Hepatomegaly, Truncus Arteriosus Persistent
F 5958682 4874771 04/19/2004 01/04/2006 Paxil Depression Abdominal Distension, Apgar Score Low, Cardiovascular Disorder, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Hypertension, Induced Labour, Influenza Like Illness, Irritability, Pulmonary Valve Stenosis, Suicidal Ideation, Transposition of the Great Vessels, Tricuspid Valve Incompetence, Ventricular Septal Defect
M 5959440 4876869 05/26/2004 01/09/2006 Paxil OT Major Depression Congenital Anomaly, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Eyelid Ptosis
F 5960350 4879792 10/30/2005 01/13/2006 Deroxat CN Bipolar I Disorder Congenital Hand Malformation, Drug Exposure During Pregnancy, Facial Dysmorphism, Haemangioma, Skull Malformation, Telangiectasia, Toe Deformity
F 5960350 4935412 10/30/2005 03/07/2006 Deroxat CN Bipolar I Disorder Congenital Hand Malformation, Congenital Nail Disorder, Drug Exposure During Pregnancy, Facial Dysmorphism, Haemangioma, Skull Malformation, Toe Deformity
F 5960350 4935525 10/30/2005 03/07/2006 Deroxat CN Bipolar I Disorder Congenital Hand Malformation, Congenital Nail Disorder, Drug Exposure During Pregnancy, Facial Dysmorphism, Haemangioma, Skull Malformation, Toe Deformity
5961270 4881514 01/16/2006 Paxil CR CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy
5961270 4927854 11/14/2005 02/28/2006 Paxil CR CN Depression Congenital Anomaly, Drug Exposure During Pregnancy, Fallot's Tetralogy, Hypoxia, Pneumonia
F 5961289 4881541 04/06/2004 01/16/2006 Deroxat CN Drug Exposure During Pregnancy, Premature Rupture of Membranes
M 5968530 4891203 01/17/2006 01/25/2006 Paxil MD Convulsion, Drug Exposure During Pregnancy, Somnolence
M 5968530 4909354 01/17/2006 02/13/2006 Paxil MD Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy, Somnolence, Somnolence Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5968530 4941130 01/17/2006 03/13/2006 Paxil MD Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Asphyxia, Somnolence
5972506 4895228 01/01/2005 01/30/2006 Paxil CN Depression Drug Exposure During Pregnancy, Premature Baby, Sepsis
5972521 4895247 01/01/2005 01/30/2006 Paxil OT Depression Drug Exposure During Pregnancy, Premature Baby, Sepsis
F 5974209 4897828 02/01/2006 Paxil CN Depression Agitation, Crying, Drug Exposure During Pregnancy, Drug Ineffective, Mood Altered
5974954 4898847 12/01/2004 02/02/2006 Paxil MD Drug Exposure During Pregnancy, Finger Hypoplasia, Nail Disorder
5974954 4946571 12/01/2004 03/17/2006 Paxil MD Drug Exposure During Pregnancy, Finger Hypoplasia, Nail Disorder, Syndactyly
5974954 5119611 10/03/2006 Paxil MD Drug Exposure During Pregnancy, Finger Hypoplasia, Nail Disorder, Syndactyly
F 5977301 4902091 02/06/2006 Paroxetine MD Drug Exposure During Pregnancy, Intra-Uterine Death
5978216 4902794 02/07/2006 Paxil MD Congenital Hand Malformation, Drug Exposure During Pregnancy, Limb Malformation
5978216 4916600 01/01/2006 02/20/2006 Paxil MD Drug Exposure During Pregnancy, Limb Malformation
F 5978881 4903841 02/08/2006 Paxil CN Panic Disorder Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
5978948 4903909 11/01/2004 02/08/2006 Paxil CN Panic Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea, Eating Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 5979098 4904192 02/08/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
F 5979366 4904463 02/08/2006 Paxil CN Depression Drug Exposure During Pregnancy, Drug Ineffective, Mood Altered, Sexual Dysfunction
F 5979497 4904606 01/01/2005 02/08/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Ineffective
F 5979499 4904608 02/08/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
5979637 4904751 02/08/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy
M 5979638 4904752 02/08/2006 Paxil CN Depression Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk
F 5979917 4905041 02/08/2006 Paxil CN Anxiety Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
5979990 4905120 02/08/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
M 5980995 4906643 02/09/2006 Seroxat CN Congenital Gastric Anomaly, Congenital Oesophageal Anomaly, Drug Exposure During Pregnancy, Dysplasia, Gastric Disorder, Toe Deformity
F 5981658 4908004 02/10/2006 Paxil CR CN Drug Use for Unknown Indication Antepartum Haemorrhage, Complication of Pregnancy, Diarrhoea, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Nausea, Night Sweats, Paraesthesia, Vaginal Haemorrhage
5983794 4910821 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
5983795 4910822 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
5983796 4910823 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
5983797 4910824 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
5983798 4910825 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
5983799 4910826 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
5983800 4910827 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
5983801 4910828 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
5983802 4910829 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
5983803 4910830 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
5983804 4910831 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
5983805 4910832 02/14/2006 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
M 5991062 4922577 02/24/2006 Paxil CN Drug Use for Unknown Indication Cardiac Disorder, Drug Exposure During Pregnancy, Heart Disease Congenital
M 5991062 4968790 04/11/2006 Paxil CN Drug Use for Unknown Indication Heart Disease Congenital
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5991062 5072615 08/07/2006 Paxil CN Drug Use for Unknown Indication Convulsion, Cyanosis, Drug Exposure During Pregnancy, Heart Disease Congenital
M 5991062 5109291 11/02/2005 09/20/2006 Paxil CN Catatonia, Cerebrovascular Accident, Convulsion, Cyanosis, Drug Exposure During Pregnancy, Eating Disorder, Facial Palsy, Heart Disease Congenital, Neurodevelopmental Disorder, Respiratory Disorder, Screaming, Skin Discolouration, Thrombosis
M 5991062 5121676 11/02/2005 10/06/2006 Paxil CR CN Maternal Condition Affecting Foetus Caesarean Section, Catatonia, Cerebrovascular Accident, Convulsion, Cyanosis, Drug Exposure During Pregnancy, Eating Disorder, Facial Palsy, Feeding Disorder Neonatal, Heart Disease Congenital, Neurodevelopmental Disorder, Postoperative Thrombosis, Psychomotor Skills Impaired, Respiratory Disorder, Screaming, Skin Discolouration, Thrombosis
M 5991062 5135404 11/02/2005 10/26/2006 Paxil CR CN Maternal Condition Affecting Foetus Caesarean Section, Catatonia, Cerebrovascular Accident, Convulsion, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Eating Disorder, Facial Palsy, Heart Disease Congenital, Life Support, Post Procedural Complication, Psychomotor Skills Impaired, Respiratory Disorder, Screaming, Skin Discolouration, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Ventricular Hypoplasia, Ventricular Septal Defect
M 5991062 5140271 11/02/2005 10/31/2006 Paxil CR CN Arrhythmia, Atrial Septal Defect, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Cerebrovascular Accident, Convulsion, Cyanosis, Dehydration, Drug Exposure During Pregnancy, Eating Disorder, Facial Palsy, Heart Disease Congenital, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Ventricular Hypoplasia, Ventricular Septal Defect, Visual Acuity Reduced
M 5991062 5146029 11/02/2005 11/08/2006 Paxil CR CN Arrhythmia, Atrial Septal Defect, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Infantile Spasms, Loss of Consciousness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Ventricular Hypoplasia, Ventricular Septal Defect, Visual Acuity Reduced
M 5991062 5155066 11/02/2005 11/21/2006 Paxil CR CN Arrhythmia, Atrial Septal Defect, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Ventricular Hypoplasia, Ventricular Septal Defect, Visual Acuity Reduced
M 5991062 5213157 11/02/2005 01/19/2007 Paxil CR CN Arrhythmia, Atrial Septal Defect, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Ventricular Hypoplasia, Ventricular Septal Defect, Visual Acuity Reduced
M 5991062 5235637 11/02/2005 02/12/2007 Paxil CR CN Arrhythmia, Atrial Septal Defect, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Ventricular Hypoplasia, Ventricular Septal Defect, Visual Acuity Reduced
M 5991062 5246955 11/02/2005 02/26/2007 Paxil CR CN Arrhythmia, Atrial Septal Defect, Balance Disorder, Blindness, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Coordination Abnormal, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Muscular Weakness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Urinary Tract Infection, Ventricular Hypoplasia, Ventricular Septal Defect, Vesicoureteric Reflux
M 5991062 5374796 11/02/2005 06/29/2007 Paxil CR CN Arrhythmia, Atrial Septal Defect, Balance Disorder, Blindness, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Coordination Abnormal, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Muscular Weakness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Urinary Tract Infection, Ventricular Hypoplasia, Ventricular Septal Defect, Vesicoureteric Reflux
M 5991062 5378691 11/02/2005 07/05/2007 Paxil CR CN Arrhythmia, Atrial Septal Defect, Balance Disorder, Blindness, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Coordination Abnormal, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Muscular Weakness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Urinary Tract Infection, Ventricular Hypoplasia, Ventricular Septal Defect, Vesicoureteric Reflux
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 5991062 5391292 11/02/2005 07/19/2007 Paxil CR CN Arrhythmia, Atrial Septal Defect, Balance Disorder, Blindness, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Coordination Abnormal, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Muscular Weakness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Urinary Tract Infection, Ventricular Hypoplasia, Ventricular Septal Defect, Vesicoureteric Reflux
M 5991062 5416701 11/02/2005 08/16/2007 Paxil CR CN Arrhythmia, Atrial Septal Defect, Balance Disorder, Blindness, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Coordination Abnormal, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Muscular Weakness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Urinary Tract Infection, Ventricular Hypoplasia, Ventricular Septal Defect, Vesicoureteric Reflux
M 5991062 5435978 11/02/2005 08/31/2007 Paxil CR CN Arrhythmia, Atrial Septal Defect, Balance Disorder, Blindness, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Coordination Abnormal, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Muscular Weakness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Speech Disorder Developmental, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Urinary Tract Infection, Ventricular Hypoplasia, Ventricular Septal Defect, Vesicoureteric Reflux
M 5991062 5443345 11/02/2005 09/05/2007 Paxil CR CN Arrhythmia, Atrial Septal Defect, Balance Disorder, Blindness, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Coordination Abnormal, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Muscular Weakness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Speech Disorder Developmental, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Urinary Tract Infection, Ventricular Hypoplasia, Ventricular Septal Defect, Vesicoureteric Reflux
M 5991062 5464256 11/02/2005 09/21/2007 Paxil CR CN Maternal Condition Affecting Foetus Arrhythmia, Atelectasis, Atrial Septal Defect, Balance Disorder, Blindness, Blood Pressure Increased, Caesarean Section, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Complex Partial Seizures, Convulsion, Coordination Abnormal, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Muscular Weakness, Oedema, Oral Intake Reduced, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pleural Effusion, Post Procedural Complication, Postoperative Thrombosis, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Speech Disorder Developmental, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Umbilical Cord Around Neck, Univentricular Heart, Urinary Tract Infection, Ventricular Hypoplasia, Ventricular Septal Defect, Vesicoureteric Reflux
M 5991062 5664446 11/02/2005 03/14/2008 Paxil CR CN Maternal Condition Affecting Foetus Arrhythmia, Atrial Septal Defect, Balance Disorder, Blindness, Blood Pressure Increased, Cardiac Failure Congestive, Cardiomegaly, Catatonia, Convulsion, Coordination Abnormal, Cyanosis, Dehydration, Developmental Delay, Drug Exposure During Pregnancy, Eating Disorder, Embolic Stroke, Encephalomalacia, Facial Palsy, Heart Disease Congenital, Hemiparesis, Infantile Spasms, Loss of Consciousness, Muscular Weakness, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Psychomotor Skills Impaired, Pulmonary Oedema, Respiratory Acidosis, Respiratory Distress, Screaming, Sinus Bradycardia, Skin Discolouration, Speech Disorder Developmental, Tachypnoea, Thrombosis, Transposition of the Great Vessels, Univentricular Heart, Urinary Tract Infection, Ventricular Hypoplasia, Ventricular Septal Defect, Vesicoureteric Reflux
M 5993272 4925293 01/25/2006 02/28/2006 Seroxat MD Drug Exposure During Pregnancy, Erythema Toxicum Neonatorum, Rash
F 5998537 4933451 01/01/2005 03/06/2006 Paroxetine CN Depression Apathy, Asthenia, Choking, Crying, Cyanosis, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dysphonia, Erythema, Extrasystoles, Eyelid Function Disorder, Fatigue, Feeling Abnormal, Hyperventilation, Ill-Defined Disorder, Oligodipsia, Somnolence, Stridor, White Blood Cell Count Increased
F 5998537 5001058 01/01/2005 05/12/2006 Paroxetine CN Depression Apathy, Asthenia, Choking, Crying, Cyanosis, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dysphonia, Erythema, Extrasystoles, Eyelid Function Disorder, Fatigue, Feeling Abnormal, Hyperventilation, Ill-Defined Disorder, Oesophageal Disorder, Oligodipsia, Somnolence, Stridor, Tracheal Disorder, White Blood Cell Count Increased
F 5998537 5012077 01/01/2005 05/26/2006 Paroxetine CN Depression Apathy, Asthenia, Choking, Crying, Cyanosis, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dysphonia, Erythema, Extrasystoles, Eyelid Function Disorder, Fatigue, Feeling Abnormal, Hyperventilation, Ill-Defined Disorder, Oesophageal Disorder, Somnolence, Stridor, Tracheal Disorder, White Blood Cell Count Increased
F 5998537 5025948 01/01/2005 06/14/2006 Paroxetine MD Depression Apathy, Asthenia, Choking, Crying, Cyanosis, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dysphonia, Erythema, Extrasystoles, Eyelid Function Disorder, Fatigue, Hyperventilation, Hyperviscosity Syndrome, Hypervolaemia, Ill-Defined Disorder, Infection, Oesophageal Disorder, Pneumonia Aspiration, Polycythaemia, Saliva Altered, Somnolence, Stridor, Tracheomalacia, White Blood Cell Count Increased
F 6001932 4939938 03/10/2006 Paxil MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6001932 4954097 03/27/2006 Paxil MD Drug Use for Unknown Indication Drug Exposure During Pregnancy
F 6001932 5501994 02/25/2006 10/30/2007 Paxil MD Dysthymic Disorder Caesarean Section, Cardiac Hypertrophy, Congenital Anomaly, Drug Exposure During Pregnancy, Ventricular Septal Defect
F 6006859 4946575 03/17/2006 Seroxat PH Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
F 6008071 4932925 02/01/2006 03/01/2006 Paroxetine MD Major Depression, Suicidal Ideation Apgar Score Low, Congenital Pulmonary Hypertension, Drug Exposure During Pregnancy, Neonatal Hypoxia, Oxygen Saturation Decreased, Respiratory Disorder Neonatal
M 6012617 4954123 02/22/2006 03/27/2006 Seroxat CN Agitation, Drug Exposure During Pregnancy, Feeling Jittery, Hypertonia, Irritability, Poor Sucking Reflex, Spina Bifida Occulta
F 6015706 4958251 03/30/2006 Seroxat MD Aggression, Binge Eating, Completed Suicide, Ill-Defined Disorder, Mania
F 6015706 4968812 04/11/2006 Seroxat MD Abortion Induced, Aggression, Binge Eating, Completed Suicide, Depression, Drug Withdrawal Syndrome, Mania, Suicide Attempt, Weight Increased
F 6015706 5525541 11/26/2007 Seroxat MD Aggression, Binge Eating, Intentional Self-Injury, Mania, Suicidal Behaviour, Weight Increased, Withdrawal Syndrome
F 6015706 5589682 05/01/2002 01/14/2008 Seroxat MD Aggression, Anxiety, Balance Disorder, Binge Eating, Disturbance In Attention, Hyperhidrosis, Intentional Self-Injury, Mania, Memory Impairment, Mood Swings, Muscle Twitching, Nausea, Paraesthesia, Suicidal Behaviour, Suicidal Ideation, Tremor, Weight Increased, Withdrawal Syndrome
F 6019774 4964544 04/06/2006 Paroxetine CN Depression Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Dyskinesia, Eating Disorder, Feeling Jittery, Hyperreflexia, Hypertonia, Intercostal Retraction, Opisthotonus, Pyrexia, Respiratory Distress, Respiratory Rate Increased, Serotonin Syndrome, Tachypnoea, Tremor
F 6020787 4966043 01/01/2001 04/07/2006 Paroxetine CN Depression Cardiac Disorder, Developmental Delay, Drug Exposure During Pregnancy, Patent Ductus Arteriosus, Talipes, Ventricular Septal Defect
M 6022900 4968791 01/01/1994 04/11/2006 Paxil CN Generalised Anxiety Disorder Autism, Caesarean Section, Depression, Drug Exposure During Pregnancy, Dysgraphia, Eating Disorder, Foetal Distress Syndrome, Learning Disability, Meconium In Amniotic Fluid, Umbilical Cord Around Neck
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6023738 4970388 05/01/2003 04/12/2006 Paxil CN Depression Intra-Uterine Death
6023741 4970391 04/12/2006 Paxil OT Drug Use for Unknown Indication Aspiration, Death, Drug Exposure During Pregnancy, Irritability, Respiratory Arrest, Respiratory Depression
6037602 4991721 03/20/2006 05/04/2006 Seroxat CN Congenital Musculoskeletal Anomaly, Drug Exposure During Pregnancy, Limb Malformation
6037602 5110253 03/20/2006 09/21/2006 Seroxat CN Congenital Musculoskeletal Anomaly, Drug Exposure During Pregnancy, Limb Malformation
F 6043436 4999771 05/11/2006 Seroxat MD Depression Anxiety, Depression, Drug Exposure During Pregnancy, Suicidal Ideation
M 6044431 5001018 10/14/2005 05/12/2006 Paxil CN Congenital Foot Malformation, Drug Exposure During Pregnancy, Syndactyly
F 6048817 5006594 05/19/2006 Paxil CN Anxiety Abnormal Dreams, Agitation, Anger, Crying, Drug Dependence, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Dysarthria, Fatigue, Mental Impairment, Stress
6049813 5007768 05/22/2006 Paroxetine CN Bipolar Disorder Drug Exposure During Pregnancy, Platelet Count Decreased, Premature Labour
M 6049814 5007769 05/22/2006 Paxil CN Depression Drug Exposure During Pregnancy, Ventricular Septal Defect
M 6049819 5007775 01/20/2003 05/22/2006 Paxil LW Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Takayasu's Arteritis, Ventricular Hypertrophy, Ventricular Septal Defect
M 6049819 5067770 01/20/2003 08/02/2006 Paxil LW Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Takayasu's Arteritis, Ventricular Hypertrophy, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6049819 5169975 01/20/2003 12/12/2006 Paxil LW Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Takayasu's Arteritis, Ventricular Hypertrophy, Ventricular Septal Defect
M 6049819 5213158 01/20/2003 01/19/2007 Paxil LW Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Failure To Thrive, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Stridor, Takayasu's Arteritis, Upper Respiratory Tract Infection, Ventricular Hypertrophy, Ventricular Septal Defect
M 6049819 5232512 01/20/2003 02/07/2007 Paxil LW Maternal Condition Affecting Foetus Abnormal Labour, Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Caesarean Section, Cardiac Murmur, Croup Infectious, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Failure To Thrive, Fallot's Tetralogy, Gait Disturbance, Heart Disease Congenital, Inguinal Hernia, Neonatal Disorder, Omphalitis, Pertussis, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Stridor, Takayasu's Arteritis, Tibial Torsion, Upper Respiratory Tract Infection, Ventricular Hypertrophy, Ventricular Septal Defect
M 6049819 5259921 01/20/2003 03/09/2007 Paxil LW Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Failure To Thrive, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Stridor, Takayasu's Arteritis, Upper Respiratory Tract Infection, Ventricular Hypertrophy, Ventricular Septal Defect
M 6049819 5468312 01/20/2003 09/26/2007 Paxil LW Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Failure To Thrive, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Right Ventricular Hypertrophy, Stridor, Takayasu's Arteritis, Upper Respiratory Tract Infection, Ventricular Septal Defect
M 6049819 5474738 01/20/2003 10/02/2007 Paxil OT Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Failure To Thrive, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Right Ventricular Hypertrophy, Stridor, Takayasu's Arteritis, Upper Respiratory Tract Infection, Ventricular Septal Defect
M 6049819 5477151 01/20/2003 10/04/2007 Paxil OT Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Failure To Thrive, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Right Ventricular Hypertrophy, Stridor, Takayasu's Arteritis, Upper Respiratory Tract Infection, Ventricular Septal Defect
M 6049819 5483753 01/20/2003 10/12/2007 Paxil OT Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Failure To Thrive, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Right Ventricular Hypertrophy, Stridor, Takayasu's Arteritis, Upper Respiratory Tract Infection, Ventricular Septal Defect
M 6049819 5541747 01/20/2003 12/10/2007 Paxil OT Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Failure To Thrive, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Right Ventricular Hypertrophy, Stridor, Takayasu's Arteritis, Upper Respiratory Tract Infection, Ventricular Septal Defect
M 6049819 5583005 01/20/2003 01/07/2008 Paxil OT Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Failure To Thrive, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Right Ventricular Hypertrophy, Stridor, Takayasu's Arteritis, Upper Respiratory Tract Infection, Ventricular Septal Defect
M 6049819 5623096 01/20/2003 02/12/2008 Paxil OT Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Failure To Thrive, Fallot's Tetralogy, Heart Disease Congenital, Pleural Effusion, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Right Ventricular Hypertrophy, Stridor, Takayasu's Arteritis, Upper Respiratory Tract Infection, Ventricular Septal Defect
F 6050448 5008653 02/15/2004 05/23/2006 Paxil LW Atrial Septal Defect, Cardiac Failure Congestive, Cardiac Murmur, Cyanosis, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Ventricular Hypertrophy, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6050448 5512875 02/15/2004 11/12/2007 Paxil LW Asthma, Atrial Septal Defect, Cardiac Disorder, Cardiac Failure Congestive, Cardiac Murmur, Cyanosis, Disease Complication, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Lung Disorder, Ventricular Hypertrophy, Ventricular Septal Defect
F 6050448 5537364 02/15/2004 12/07/2007 Paxil LW Activated Partial Thromboplastin Time Prolonged, Asthma, Atrial Septal Defect, Cardiac Disorder, Cardiac Failure Congestive, Cardiac Murmur, Cyanosis, Disease Complication, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hyperkalaemia, Hypokalaemia, Lung Disorder, Ventricular Hypertrophy, Ventricular Septal Defect
F 6050448 5593283 02/15/2004 01/16/2008 Paxil LW Activated Partial Thromboplastin Time Prolonged, Asthma, Atrial Septal Defect, Cardiac Disorder, Cardiac Failure Congestive, Cardiac Murmur, Cyanosis, Disease Complication, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hyperkalaemia, Hypokalaemia, Lung Disorder, Ventricular Hypertrophy, Ventricular Septal Defect
F 6050448 5607951 02/15/2004 01/30/2008 Paxil LW Activated Partial Thromboplastin Time Prolonged, Asthma, Atrial Septal Defect, Cardiac Disorder, Cardiac Failure Congestive, Cardiac Murmur, Cyanosis, Disease Complication, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hyperkalaemia, Hypokalaemia, Hypoxia, Lung Disorder, Ventricular Hypertrophy, Ventricular Septal Defect
F 6050448 5623097 02/15/2004 02/12/2008 Paxil LW Anxiety Activated Partial Thromboplastin Time Prolonged, Asthma, Atrial Septal Defect, Cardiac Disorder, Cardiac Failure Congestive, Cardiac Murmur, Cyanosis, Disease Complication, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hyperkalaemia, Hypokalaemia, Hypoxia, Lung Disorder, Ventricular Hypertrophy, Ventricular Septal Defect
F 6054856 5013618 08/01/1997 05/30/2006 Paroxetine MD Abortion Missed, Diarrhoea, Dizziness, Drug Withdrawal Syndrome, Insomnia, Palpitations, Weight Decreased
M 6060128 5020047 06/07/2006 Paxil CN Anxiety Disorder Cardiac Disorder, Congenital Aortic Valve Incompetence, Drug Exposure During Pregnancy, Foetal Malformation, Hypospadias, Polydactyly, Ventricular Septal Defect
M 6060128 5031561 04/17/2006 06/21/2006 Paxil CN Anxiety Disorder Atrial Septal Defect, Congenital Aortic Valve Incompetence, Drug Exposure During Pregnancy, Hypospadias, Polydactyly, Ventricular Septal Defect
6064283 5025199 06/13/2006 Paxil PH Drug Exposure During Pregnancy, Respiratory Disorder
6064283 5031581 06/01/2006 06/21/2006 Paxil PH Drug Exposure During Pregnancy, Respiratory Disorder
6064283 5033677 06/01/2006 06/23/2006 Paxil PH Apgar Score Abnormal, Apnoea, Drug Exposure During Pregnancy, Hypertonia, Hypotonia, Irritability, Muscle Twitching, Respiratory Disorder, Somnolence, Tachypnoea
6064283 5050566 06/01/2006 07/13/2006 Paxil PH Apnoea, Congenital Anomaly, Drug Exposure During Pregnancy, Hypertonia, Hypotonia, Intentional Overdose, Irritability, Muscle Twitching, Neuromyopathy, Respiratory Disorder, Somnolence, Tachypnoea
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6069524 5029219 06/13/2006 Paxil MD Chills, Chorea, Crying, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypertonia, Irritability, Premature Baby
6069524 5031576 06/21/2006 Paroxetine CN Chills, Chorea, Crying, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder of Infancy or Early Childhood, Hypertonia, Irritability, Premature Labour
M 6069524 5140287 10/31/2006 Paroxetine CN Asthenia, Body Temperature Fluctuation, Chills, Chorea, Crying, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Eating Disorder, Feeding Disorder of Infancy or Early Childhood, Hyperreflexia, Hypertonia, Hypoventilation, Irritability, Premature Baby, Respiratory Distress, Tremor
F 6078538 5045220 07/07/2006 Paxil PH Dizziness, Drug Exposure During Pregnancy, Palpitations, Stillbirth
F 6081820 5060844 06/05/2006 07/25/2006 Paroxetine CN Bipolar Disorder Drug Exposure During Pregnancy, Pulmonary Hypertension
M 6086301 5056159 07/07/2006 07/20/2006 Paxil MD Drug Exposure During Pregnancy, Somnolence
M 6086301 5091474 07/07/2006 08/29/2006 Paxil MD Apgar Score Low, Apnoea, Drug Exposure During Pregnancy, Hypotonia, Neonatal Asphyxia, Neonatal Disorder, Respiratory Disorder, Somnolence
M 6086301 5151320 07/07/2006 11/15/2006 Paxil MD Apgar Score Low, Apnoea, Drug Exposure During Pregnancy, Hypotonia, Neonatal Asphyxia, Neonatal Disorder, Respiratory Disorder, Somnolence
M 6086301 5293517 07/07/2006 04/11/2007 Paxil MD Apgar Score Low, Apnoea, Depression, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hypotonia, Neonatal Asphyxia, Neonatal Disorder, Respiratory Disorder, Somnolence
M 6099271 5071458 04/19/2004 08/04/2006 Paxil CN Developmental Delay, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Heart Disease Congenital, Patent Ductus Arteriosus, Pulmonary Valve Stenosis, Transposition of the Great Vessels, Ventricular Septal Defect
M 6099271 5101395 04/19/2004 09/11/2006 Paxil CN Developmental Delay, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Heart Disease Congenital, Patent Ductus Arteriosus, Pulmonary Valve Stenosis, Transposition of the Great Vessels, Ventricular Septal Defect
M 6099271 5523313 04/19/2004 11/21/2007 Paxil CN Depression Aggression, Developmental Delay, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Emotional Disorder, Emotional Distress, Fear, Heart Disease Congenital, Patent Ductus Arteriosus, Pulmonary Valve Stenosis, Transposition of the Great Vessels, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6099271 5610988 04/19/2004 02/01/2008 Paxil CN Depression Aggression, Anaemia, Aortic Valve Incompetence, Atelectasis, Atrial Septal Defect, Atrioventricular Block, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Collapse of Lung, Cyanosis, Developmental Delay, Dilatation Atrial, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyskinesia, Eating Disorder, Emotional Disorder, Emotional Distress, Fear, Heart Disease Congenital, Hyperhidrosis, Hypokalaemia, Hypotension, Irritability, Lung Disorder, Metabolic Acidosis, Motor Dysfunction, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pericardial Effusion, Pleural Effusion, Postoperative Wound Infection, Pulmonary Valve Stenosis, Pyrexia, Respiratory Failure, Septic Shock, Thrombocytopenia, Transposition of the Great Vessels, Tricuspid Valve Incompetence, Ventricular Septal Defect
M 6099271 5642961 04/19/2004 02/28/2008 Paxil CN Depression Aggression, Anaemia, Aortic Valve Incompetence, Atelectasis, Atrial Septal Defect, Atrioventricular Block, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Collapse of Lung, Cyanosis, Developmental Delay, Dilatation Atrial, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyskinesia, Eating Disorder, Emotional Disorder, Emotional Distress, Fear, Heart Disease Congenital, Hyperhidrosis, Hypokalaemia, Hypotension, Irritability, Lung Disorder, Metabolic Acidosis, Motor Dysfunction, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pericardial Effusion, Pleural Effusion, Postoperative Wound Infection, Pulmonary Valve Stenosis, Pyrexia, Respiratory Failure, Septic Shock, Thrombocytopenia, Transposition of the Great Vessels, Tricuspid Valve Incompetence, Ventricular Septal Defect
M 6099805 5068980 07/10/2001 08/01/2006 Paxil Anxiety, Depression Apgar Score Low, Apraxia, Brain Stem Syndrome, Cerebral Palsy, Convulsion Neonatal, Deafness, Developmental Delay, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyskinesia, Dyskinesia Neonatal, Feeding Disorder Neonatal, Hemiparesis, Hypotonia, Infantile Apnoeic Attack, Jaundice Neonatal, Lethargy, Loss of Consciousness, Neonatal Disorder, Sensory Integrative Dysfunction, Vomiting Neonatal, Weight Decrease Neonatal
F 6103605 5077109 08/10/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy
M 6103610 5077114 08/10/2006 Paxil CN Drug Exposure Via Breast Milk
F 6103623 5077127 01/01/2005 08/10/2006 Paxil CN Depression Drug Exposure During Pregnancy, Irritability, Nervousness
F 6103670 5077175 08/10/2006 Paxil MD Drug Use for Unknown Indication Drug Exposure During Pregnancy
6103977 5077475 01/01/2006 08/10/2006 Paxil OT Drug Use for Unknown Indication Drug Exposure During Pregnancy, Respiratory Distress
6103978 5077476 08/10/2006 Paxil OT Drug Use for Unknown Indication Drug Exposure During Pregnancy, Respiratory Distress
6104075 5077576 08/10/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure Via Breast Milk
F 6104099 5077600 08/10/2006 Paxil CN Drug Use for Unknown Indication Dizziness, Drug Exposure During Pregnancy
F 6104121 5077622 08/10/2006 Paxil CN Drug Use for Unknown Indication Abortion Spontaneous, Drug Withdrawal Syndrome, Intra-Uterine Death
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6106109 5079149 08/04/2000 08/14/2006 Paxil CN Depression Bundle Branch Block Right, Cardiac Murmur, Cardiac Valve Disease, Cardiomegaly, Congenital Anomaly, Cyanosis Neonatal, Dilatation Ventricular, Drug Exposure During Pregnancy, Heart Valve Stenosis, Truncus Arteriosus Persistent, Ventricular Dysfunction, Ventricular Septal Defect
F 6106109 5123236 08/04/2000 10/09/2006 Paxil CN Depression Cardiomegaly, Congenital Anomaly, Dilatation Ventricular, Drug Exposure During Pregnancy, Truncus Arteriosus Persistent, Ventricular Septal Defect
F 6106109 5197116 08/04/2000 01/03/2007 Paxil CN Depression Aortic Stenosis, Aortic Valve Incompetence, Bundle Branch Block Right, Cardiomegaly, Congenital Anomaly, Dilatation Ventricular, Drug Exposure During Pregnancy, Mitral Valve Incompetence, Pulmonary Valve Incompetence, Pulmonary Vascular Disorder, Tricuspid Valve Incompetence, Truncus Arteriosus Persistent, Vascular Calcification, Vascular Graft Complication, Ventricular Septal Defect
F 6106109 5329971 08/04/2000 05/21/2007 Paxil CN Depression Aortic Stenosis, Breech Presentation, Bundle Branch Block Right, Cardiomegaly, Congenital Anomaly, Cyanosis, Dilatation Ventricular, Drug Exposure During Pregnancy, Heart Rate Increased, Heart Valve Insufficiency, Mitral Valve Incompetence, Respiratory Disorder, Tricuspid Valve Incompetence, Truncus Arteriosus Persistent, Ventricular Dysfunction, Ventricular Septal Defect
F 6106109 5332327 08/04/2000 05/23/2007 Paxil CN Depression Aortic Stenosis, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Congenital Anomaly, Dilatation Ventricular, Drug Exposure During Pregnancy, Heart Valve Insufficiency, Pectus Excavatum, Truncus Arteriosus Persistent, Ventricular Septal Defect
F 6106109 5340156 08/04/2000 05/31/2007 Paxil CN Depression Aortic Stenosis, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Congenital Anomaly, Dilatation Ventricular, Drug Exposure During Pregnancy, Heart Valve Insufficiency, Oxygen Saturation Decreased, Pectus Excavatum, Truncus Arteriosus Persistent, Ventricular Septal Defect
F 6106109 5391293 08/04/2000 07/19/2007 Paxil CN Depression Aortic Stenosis, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Congenital Anomaly, Dilatation Ventricular, Drug Exposure During Pregnancy, Heart Valve Incompetence, Oxygen Saturation Decreased, Pectus Excavatum, Truncus Arteriosus Persistent, Ventricular Septal Defect
F 6106109 5406012 08/04/2000 08/06/2007 Paxil CN Depression Aortic Stenosis, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Congenital Anomaly, Dilatation Ventricular, Drug Exposure During Pregnancy, Heart Valve Incompetence, Oxygen Saturation Decreased, Pectus Excavatum, Truncus Arteriosus Persistent, Ventricular Septal Defect
F 6106109 5585502 08/04/2000 01/09/2008 Paxil CN Depression Aortic Stenosis, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Congenital Anomaly, Dilatation Ventricular, Drug Exposure During Pregnancy, Heart Valve Incompetence, Oxygen Saturation Decreased, Pectus Excavatum, Truncus Arteriosus Persistent, Ventricular Septal Defect
F 6106109 5615596 08/04/2000 02/06/2008 Paxil CN Depression Aortic Stenosis, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Congenital Anomaly, Dilatation Ventricular, Drug Exposure During Pregnancy, Heart Valve Incompetence, Oxygen Saturation Decreased, Pectus Excavatum, Truncus Arteriosus Persistent, Ventricular Septal Defect
6108732 5081780 08/16/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
6108733 5081781 08/16/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6108734 5081782 08/16/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
6108735 5081783 08/16/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
6108736 5081784 08/16/2006 Paxil LW Maternal Condition Affecting Foetus Drug Exposure During Pregnancy, Heart Disease Congenital
6108737 5081785 08/16/2006 Paxil LW Maternal Condition Affecting Foetus Drug Exposure During Pregnancy, Heart Disease Congenital
6108738 5081786 08/16/2006 Paxil LW Maternal Condition Affecting Foetus Drug Exposure During Pregnancy, Heart Disease Congenital
6108739 5081787 08/16/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
6108740 5081788 08/16/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
6108741 5081789 08/16/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
6108742 5081790 08/16/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
6108743 5081791 08/16/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
6108744 5081792 08/16/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
6108745 5081793 08/16/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6108746 5081794 08/16/2006 Paxil LW Maternal Condition Affecting Foetus Drug Exposure During Pregnancy, Heart Disease Congenital
6108748 5081795 08/16/2006 Paxil LW Maternal Condition Affecting Foetus Drug Exposure During Pregnancy, Heart Disease Congenital
F 6108760 5110260 06/01/2006 09/21/2006 Paxil MD Anxiety Disorder Abdominal Distension, Congenital Anomaly, Congenital Megacolon, Drug Exposure During Pregnancy, Jaundice Neonatal, Respiratory Disorder
6118611 5093000 08/30/2006 Seroxat CN Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome
F 6125158 5101430 01/01/2006 09/11/2006 Deroxat CN Drug Exposure During Pregnancy, Premature Labour
F 6125158 5105873 01/01/2006 09/15/2006 Deroxat CN Delusional Disorder (Persecutory Type) Drug Exposure During Pregnancy, Premature Labour, Threatened Labour
M 6125159 5101431 05/01/2006 09/11/2006 Deroxat CN 21-Hydroxylase Deficiency, Drug Exposure During Pregnancy, Escherichia Sepsis, Foetal Distress Syndrome, Haematoma, Hypotonia, Macrosomia, Meconium Ileus, Necrotising Enterocolitis Neonatal, Oedema, Premature Baby, Urine Sodium Increased, Weight Decreased
F 6126386 5097891 08/30/2004 09/05/2006 Paxil MD Anxiety, Depression Congenital Central Nervous System Anomaly, Convulsion Neonatal, Drug Exposure During Pregnancy
M 6126498 5096681 08/31/2006 Paroxetine Chills, Chorea, Crying, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hyperreflexia, Hypertonia Neonatal, Irritability, Neonatal Disorder, Neonatal Respiratory Depression, Premature Baby, Temperature Regulation Disorder
M 6126498 5103034 09/08/2006 Paroxetine Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Neonatal Disorder, Neonatal Respiratory Depression, Premature Baby, Temperature Regulation Disorder
6129744 5097902 09/05/2006 Paroxetine MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Polydactyly
M 6131483 5109306 06/01/2006 09/20/2006 08/01/2006 Paxil CN Congenital Pulmonary Artery Anomaly, Deformity, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6131483 5136283 06/01/2006 10/27/2006 08/01/2006 Paxil LW Congenital Pulmonary Artery Anomaly, Deformity, Drug Exposure During Pregnancy
M 6131483 5389227 06/01/2006 07/17/2007 08/01/2006 Paxil LW Maternal Condition Affecting Foetus Congenital Anomaly, Congenital Pulmonary Artery Anomaly, Deformity, Drug Exposure During Pregnancy
M 6131483 5594763 06/02/2005 01/17/2008 08/01/2005 Paxil CR LW Depression Cardiac Disorder, Congenital Pulmonary Artery Anomaly, Congenital Tracheomalacia, Drug Exposure During Pregnancy, Heart Disease Congenital, Multiple Congenital Abnormalities, Pulmonary Hypertension, Pulmonary Malformation
M 6131483 5680417 06/02/2005 03/26/2008 08/01/2005 Paxil CR LW Depression Cardiac Disorder, Congenital Pulmonary Artery Anomaly, Congenital Tracheomalacia, Drug Exposure During Pregnancy, Heart Disease Congenital, Multiple Congenital Abnormalities, Pulmonary Hypertension, Pulmonary Malformation
6131484 5109307 09/20/2006 Paxil LW Atrial Septal Defect, Congenital Anomaly, Drug Exposure During Pregnancy, Ventricular Septal Defect
6131485 5109308 09/20/2006 Paxil LW Congenital Arterial Malformation, Drug Exposure During Pregnancy
6131486 5109309 09/20/2006 Paxil LW Drug Exposure During Pregnancy, Heart Disease Congenital
F 6134394 5112716 09/22/2006 Paxil PH Drug Use for Unknown Indication Abortion Induced, Drug Exposure During Pregnancy, Musculoskeletal Stiffness
F 6134394 5127713 10/16/2006 Paxil PH Depression Abortion Induced, Disease Recurrence, Drug Exposure During Pregnancy, Drug Interaction, Mental Disorder, Musculoskeletal Stiffness, Placenta Praevia
F 6134394 5145036 11/07/2006 Paxil PH Depression Abortion Induced, Anxiety, Drug Interaction, Mental Disorder, Musculoskeletal Stiffness, Tremor
F 6135500 5114110 09/08/2006 09/25/2006 Paroxetine CN Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Respiratory Depression
F 6135500 5116667 09/08/2006 09/28/2006 Paroxetine CN Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Respiratory Depression
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6137767 5116235 09/27/2006 Paxil CN Drug Use for Unknown Indication Atrial Septal Defect, Cardiac Disorder, Drug Exposure During Pregnancy, Transposition of the Great Vessels
F 6137767 5134599 03/11/1999 10/25/2006 Paxil CN Drug Use for Unknown Indication Atrial Septal Defect, Cardiac Disorder, Congenital Anomaly, Drug Exposure During Pregnancy, Patent Ductus Arteriosus, Pulmonary Valve Stenosis, Transposition of the Great Vessels
F 6137767 5525497 03/11/1999 11/26/2007 Paxil CN Anxiety Aortic Valve Incompetence, Atelectasis, Atrial Septal Defect, Cardiac Failure, Cardiac Murmur, Cardiomegaly, Chest Pain, Cough, Cyanosis, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Failure To Thrive, Feeding Disorder Neonatal, Food Aversion, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Hypertension, Hypotension, Left Atrial Dilatation, Lung Infection Pseudomonal, Lung Infiltration, Oesophagogastric Fundoplasty, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Premature Baby, Pulmonary Hypertension, Pulmonary Oedema, Pulmonary Valve Stenosis, Respiratory Distress, Sepsis, Staphylococcal Infection, Transposition of the Great Vessels, Tricuspid Valve Incompetence, Ventricular Septal Defect, Vomiting
F 6137767 5589603 03/11/1999 01/14/2008 Paxil CN Anxiety Anxiety, Aortic Valve Incompetence, Atelectasis, Atrial Septal Defect, Cardiac Failure, Cardiac Murmur, Cardiomegaly, Chest Pain, Cough, Cyanosis, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Failure To Thrive, Feeding Disorder Neonatal, Food Aversion, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Hypertension, Hypotension, Left Atrial Dilatation, Lung Infection Pseudomonal, Lung Infiltration, Oesophagogastric Fundoplasty, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Premature Baby, Pulmonary Hypertension, Pulmonary Oedema, Pulmonary Valve Stenosis, Respiratory Distress, Sepsis, Staphylococcal Infection, Transposition of the Great Vessels, Tricuspid Valve Incompetence, Ventricular Septal Defect, Vomiting
F 6137767 5618453 03/11/1999 02/07/2008 Paxil CN Anxiety Anxiety, Aortic Valve Incompetence, Atelectasis, Atrial Septal Defect, Cardiac Failure, Cardiac Murmur, Cardiomegaly, Chest Pain, Cough, Cyanosis, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Failure To Thrive, Feeding Disorder Neonatal, Food Aversion, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Hypertension, Hypotension, Left Atrial Dilatation, Lung Infection Pseudomonal, Lung Infiltration, Oesophagogastric Fundoplasty, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Premature Baby, Pulmonary Hypertension, Pulmonary Oedema, Pulmonary Valve Stenosis, Respiratory Distress, Respiratory Failure, Sepsis, Staphylococcal Infection, Transposition of the Great Vessels, Tricuspid Valve Incompetence, Ventricular Septal Defect, Vomiting
F 6137767 5629638 03/11/1999 02/18/2008 Paxil CN Anxiety Anxiety, Aortic Valve Incompetence, Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Chest Pain, Cough, Cyanosis, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Failure To Thrive, Feeding Disorder Neonatal, Food Aversion, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Hypertension, Hypotension, Hypoxia, Left Atrial Dilatation, Left Ventricular Hypertrophy, Lung Infection Pseudomonal, Lung Infiltration, Oesophagogastric Fundoplasty, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Premature Baby, Pulmonary Hypertension, Pulmonary Oedema, Pulmonary Valve Stenosis, Respiratory Distress, Respiratory Failure, Sepsis, Staphylococcal Infection, Tachycardia, Transposition of the Great Vessels, Tricuspid Valve Incompetence, Ventricular Septal Defect, Vomiting
F 6148258 5128583 10/17/2006 Seroxat MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Suicidal Ideation
M 6150210 5124482 07/04/2006 10/06/2006 Paxil Bradycardia Neonatal, Bradypnoea, Caesarean Section, Cyanosis Neonatal, Drug Exposure During Pregnancy, Hypoventilation Neonatal, Moaning, Neonatal Respiratory Distress Syndrome, Somnolence Neonatal
F 6150539 5131397 10/20/2006 Paxil CR CN Placenta Praevia, Uterine Contractions Abnormal
M 6150551 5131408 10/20/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Persistent Foetal Circulation
M 6150551 5143474 10/28/2004 11/03/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Dyspepsia, Eating Disorder, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Persistent Foetal Circulation
M 6150551 5456523 10/28/2004 09/18/2007 Paxil CN Drug Use for Unknown Indication Developmental Delay, Drug Exposure During Pregnancy, Dyspepsia, Eating Disorder, Gastrooesophageal Reflux Disease, Persistent Foetal Circulation, Respiratory Distress
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6150566 5131429 05/21/2006 10/20/2006 Deroxat CN Drug Exposure During Pregnancy, Thrombocytopenia Neonatal
M 6155105 5136325 10/08/2006 10/27/2006 Paroxetine OT Depression Chills, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Intracranial Pressure Increased, Myoclonus, Shoulder Dystocia
6161930 5144059 11/06/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
6161931 5144060 11/06/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
6166510 5149303 05/11/2006 11/13/2006 Paxil MD Panic Disorder Hypothyroidism, Premature Baby
6166510 5200091 05/11/2006 01/05/2007 Paxil MD Drug Use for Unknown Indication Anaemia, Anaemia Neonatal, Congenital Hypothyroidism, Drug Exposure During Pregnancy, Hypothyroidism, Premature Baby
F 6166510 5222815 05/17/2006 01/29/2007 Paxil MD Panic Disorder Anaemia, Drug Exposure During Pregnancy, Hypothyroidism, Premature Baby
F 6166510 5249845 05/17/2006 02/28/2007 Paxil MD Panic Disorder Anaemia, Drug Exposure During Pregnancy, Hypothyroidism, Premature Baby, Premature Rupture of Membranes, Small for Dates Baby
F 6166510 5326354 05/17/2006 05/16/2007 Paxil MD Panic Disorder Anaemia, Anaemia Neonatal, Drug Exposure During Pregnancy, Hypothyroidism, Neonatal Disorder, Premature Baby, Premature Rupture of Membranes, Small for Dates Baby
6168397 5151336 11/15/2006 Paroxetine CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Talipes
6168398 5151337 11/15/2006 Paroxetine CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Haemangioma of Skin, Melanocytic Naevus
6168399 5151338 11/15/2006 Paroxetine CN Drug Use for Unknown Indication Congenital Torticollis, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6172342 5156300 07/21/2005 11/22/2006 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy, Injury, Scar
F 6172342 5569630 07/21/2005 12/20/2007 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy, Injury, Scar
M 6173586 5157481 09/01/2002 11/27/2006 Paxil CN Asthma, Drug Exposure During Pregnancy, Dyspnoea, Premature Baby, Tooth Disorder
M 6177938 5162821 01/01/2006 12/01/2006 03/31/2006 Paxil CR CN Depression Ascites, Cardiomegaly, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hydrops Foetalis, Intra-Uterine Death, Localised Oedema, Stillbirth, Tricuspid Valve Incompetence
M 6177938 5477154 01/01/2006 10/04/2007 03/31/2006 Paxil CR CN Depression Ascites, Cardiac Failure, Cardiomegaly, Congenital Pulmonary Valve Disorder, Drug Exposure During Pregnancy, Fallot's Tetralogy, Foetal Disorder, Heart Disease Congenital, Hydrops Foetalis, Intra-Uterine Death, Localised Oedema, Pulmonary Artery Dilatation, Stillbirth, Tricuspid Valve Incompetence
M 6177938 5593284 01/01/2006 01/16/2008 03/31/2006 Paxil CR CN Depression Ascites, Cardiomegaly, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hydrops Foetalis, Intra-Uterine Death, Localised Oedema, Pericardial Effusion, Placental Disorder, Pleural Effusion, Skin Oedema, Stillbirth, Tricuspid Valve Incompetence
M 6177938 5597557 01/01/2006 01/21/2008 03/31/2006 Paxil CR CN Depression Ascites, Cardiomegaly, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hydrops Foetalis, Intra-Uterine Death, Localised Oedema, Pericardial Effusion, Placental Disorder, Pleural Effusion, Skin Oedema, Stillbirth, Tricuspid Valve Incompetence
M 6177938 5601247 01/01/2006 01/24/2008 03/31/2006 Paxil CR CN Depression Ascites, Cardiomegaly, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hydrops Foetalis, Intra-Uterine Death, Localised Oedema, Pericardial Effusion, Placental Disorder, Pleural Effusion, Skin Oedema, Stillbirth, Tricuspid Valve Incompetence
M 6177938 5607952 01/01/2006 01/30/2008 03/31/2006 Paxil CR CN Depression Ascites, Cardiomegaly, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hydrops Foetalis, Intra-Uterine Death, Localised Oedema, Pericardial Effusion, Placental Disorder, Pleural Effusion, Skin Oedema, Stillbirth, Tricuspid Valve Incompetence
M 6177973 5162869 02/01/2006 12/01/2006 Deroxat CN Depression Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Foetal Growth Retardation, Foetal Movements Decreased, Hypercalcaemia, Hyperthermia, Hypotonia Neonatal, Somnolence, Weight Decrease Neonatal
F 6178839 5163674 06/26/2006 12/04/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Respiratory Disorder Neonatal
F 6178839 5207183 06/26/2006 01/12/2007 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Respiratory Disorder Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6179633 5164726 01/01/2001 12/05/2006 Paxil CN Panic Disorder Abortion Induced, Divorced, Drug Exposure During Pregnancy, Emotional Disorder, Emotional Distress, Self Esteem Decreased
M 6179634 5164727 01/01/2001 12/05/2006 Paxil CN Panic Disorder Congenital Anomaly, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy, Patent Ductus Arteriosus
F 6180382 5165565 09/26/2004 12/06/2006 10/26/2004 Paxil CN Drug Use for Unknown Indication Death, Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome
F 6180382 5171054 09/26/2004 12/13/2006 10/26/2004 Paxil CN Drug Use for Unknown Indication Death, Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome
F 6180382 5358887 09/26/2004 06/15/2007 10/26/2004 Paxil CN Drug Use for Unknown Indication Death, Drug Exposure During Pregnancy, Dyspnoea, Feeding Disorder Neonatal, Hypoplastic Left Heart Syndrome, Neonatal Disorder, Ventricular Hypoplasia
F 6180382 5396628 09/26/2004 07/25/2007 10/13/2004 Paxil CN Drug Use for Unknown Indication Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy, Dyspnoea, Feeding Disorder Neonatal, Hypoplastic Left Heart Syndrome, Neonatal Disorder, Pain, Ventricular Hypoplasia
F 6180382 5518238 09/26/2004 11/15/2007 10/13/2004 Paxil CR CN Drug Use for Unknown Indication Arterial Thrombosis, Atrial Septal Defect, Bradycardia, Brain Oedema, Cardiac Arrest, Congenital Cardiovascular Anomaly, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Dyspnoea, Endocardial Fibrosis, Feeding Disorder Neonatal, Fluid Overload, Hepatomegaly, Hydronephrosis, Hypoplastic Left Heart Syndrome, Hypotension, Mitral Valve Incompetence, Myocardial Infarction, Necrosis, Neonatal Disorder, Pain, Pulmonary Congestion, Renal Failure, Ventricular Hypoplasia, Ventricular Septal Defect
F 6180382 5621931 09/26/2004 02/11/2008 10/13/2004 Paxil CR CN Drug Use for Unknown Indication Arterial Thrombosis, Atrial Septal Defect, Bradycardia, Brain Oedema, Cardiac Arrest, Congenital Cardiovascular Anomaly, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Dyspnoea, Endocardial Fibrosis, Feeding Disorder Neonatal, Fluid Overload, Hepatomegaly, Hydronephrosis, Hypoplastic Left Heart Syndrome, Hypotension, Mitral Valve Incompetence, Myocardial Infarction, Necrosis, Neonatal Disorder, Pain, Pulmonary Congestion, Renal Failure, Ventricular Hypoplasia, Ventricular Septal Defect
F 6180383 5165566 10/17/2002 12/06/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Dyspnoea, Ventricular Septal Defect
F 6180383 5171055 10/17/2002 12/13/2006 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Dyspnoea, Ventricular Septal Defect
F 6180383 5522172 10/17/2002 11/20/2007 Paxil CN Drug Use for Unknown Indication Abnormal Behaviour, Aggression, Anger, Anxiety, Apnoeic Attack, Atrial Septal Defect, Bereavement Reaction, Drug Exposure During Pregnancy, Dyspnoea, Emotional Disorder, Emotional Distress, Pain, Regressive Behaviour, Shock, Speech Disorder, Ventricular Septal Defect
F 6180383 5607953 10/17/2002 01/30/2008 Paxil CN Drug Use for Unknown Indication Abnormal Behaviour, Aggression, Anger, Anxiety, Apnoeic Attack, Atrial Septal Defect, Bereavement Reaction, Drug Exposure During Pregnancy, Dyspnoea, Emotional Disorder, Emotional Distress, Pain, Regressive Behaviour, Shock, Speech Disorder, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6180383 5663059 10/17/2002 03/13/2008 Paxil CN Drug Use for Unknown Indication Abnormal Behaviour, Aggression, Anaemia, Anger, Anxiety, Apnoea, Apnoeic Attack, Atrial Septal Defect, Bereavement Reaction, Drug Exposure During Pregnancy, Dyspnoea, Emotional Disorder, Emotional Distress, Foetal Distress Syndrome, Hyperbilirubinaemia, Pain, Premature Baby, Regressive Behaviour, Respiratory Distress, Shock, Speech Disorder, Ventricular Septal Defect
F 6180384 5165567 04/24/2004 12/06/2006 Paxil CN Drug Use for Unknown Indication Aortic Disorder, Cardiac Valve Disease, Drug Exposure During Pregnancy, Fallot's Tetralogy, Hypertrophy, Obstructive Airways Disorder, Ventricular Septal Defect
6180536 5158881 11/15/2006 Paxil Drug Use for Unknown Indication Drug Exposure During Pregnancy, Talipes
6180585 5158890 11/15/2006 Paxil Drug Use for Unknown Indication Congenital Torticollis, Drug Exposure During Pregnancy
6180587 5158893 11/15/2006 Paxil Drug Use for Unknown Indication Drug Exposure During Pregnancy, Haemangioma Congenital
M 6183331 5169977 01/14/2002 12/12/2006 02/07/2002 Paxil CN Drug Use for Unknown Indication Cardiac Murmur, Drug Exposure During Pregnancy, Heart Disease Congenital, Hypoplastic Left Heart Syndrome
M 6183331 5171071 01/14/2002 12/13/2006 02/07/2002 Paxil CN Drug Use for Unknown Indication Cardiac Murmur, Drug Exposure During Pregnancy, Heart Disease Congenital, Hypoplastic Left Heart Syndrome
M 6183331 5327625 01/14/2002 05/17/2007 02/07/2002 Paxil CN Drug Use for Unknown Indication Cardiac Failure, Cardiac Murmur, Drug Exposure During Pregnancy, Heart Disease Congenital, Hypoplastic Left Heart Syndrome, Pulmonary Malformation, Respiratory Failure
M 6183331 5519515 01/14/2002 11/16/2007 02/07/2002 Paxil CN Depression Anuria, Aortic Stenosis, Atrial Septal Defect, Bronchopneumonia, Cardiac Failure, Cardiac Murmur, Cardiogenic Shock, Cardiomegaly, Coarctation of the Aorta, Cyanosis, Drug Exposure During Pregnancy, Endocardial Fibroelastosis, Haemorrhage Intracranial, Heart Disease Congenital, Hyperkalaemia, Hypoplastic Left Heart Syndrome, Hypotension, Metabolic Acidosis, Mitral Valve Incompetence, Multi-Organ Failure, Myocardial Infarction, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Premature Baby, Pulmonary Embolism, Pulmonary Haemorrhage, Pulmonary Infarction, Pulmonary Malformation, Pyrexia, Respiratory Distress, Respiratory Failure, Tricuspid Valve Incompetence, White Blood Cell Count Increased
M 6183331 5598308 01/14/2002 01/22/2008 02/07/2002 Paxil CN Depression Anuria, Aortic Stenosis, Atrial Septal Defect, Bronchopneumonia, Cardiac Failure, Cardiac Murmur, Cardiogenic Shock, Cardiomegaly, Coarctation of the Aorta, Cyanosis, Drug Exposure During Pregnancy, Endocardial Fibroelastosis, Haemorrhage Intracranial, Heart Disease Congenital, Hepatic Function Abnormal, Hyperkalaemia, Hypoplastic Left Heart Syndrome, Hypotension, Metabolic Acidosis, Mitral Valve Incompetence, Multi-Organ Failure, Myocardial Infarction, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Premature Baby, Pulmonary Embolism, Pulmonary Haemorrhage, Pulmonary Infarction, Pulmonary Malformation, Pyrexia, Renal Impairment, Respiratory Distress, Respiratory Failure, Sepsis, Thrombocytopenia, Tricuspid Valve Incompetence, White Blood Cell Count Increased
M 6183334 5169980 02/02/2005 12/12/2006 Paxil CN Drug Use for Unknown Indication Congenital Tricuspid Valve Atresia, Heart Disease Congenital, Pulmonary Valve Stenosis, Ventricular Septal Defect
M 6183334 5171073 02/02/2005 12/13/2006 Paxil CN Drug Use for Unknown Indication Congenital Tricuspid Valve Atresia, Heart Disease Congenital, Pulmonary Valve Stenosis, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6183334 5522173 02/02/2005 11/20/2007 Paxil CN Anxiety Atrial Septal Defect, Cardiac Murmur, Congenital Tricuspid Valve Atresia, Cyanosis, Haemoglobin Decreased, Haemorrhage, Heart Disease Congenital, Metabolic Acidosis, Oxygen Saturation Decreased, Pleural Effusion, Pneumomediastinum, Pneumothorax, Pulmonary Valve Stenosis, Right Atrial Dilatation, Right Ventricular Hypertrophy, Ventricular Septal Defect
M 6183334 5585503 02/02/2005 01/09/2008 Paxil CN Anxiety Atrial Septal Defect, Cardiac Murmur, Congenital Tricuspid Valve Atresia, Cyanosis, Haemoglobin Decreased, Haemorrhage, Heart Disease Congenital, Metabolic Acidosis, Oxygen Saturation Decreased, Pleural Effusion, Pneumomediastinum, Pneumothorax, Pulmonary Valve Stenosis, Right Atrial Dilatation, Right Ventricular Hypertrophy, Ventricular Septal Defect
M 6183334 5621932 02/02/2005 02/11/2008 Paxil CN Anxiety Atrial Septal Defect, Cardiac Murmur, Coagulopathy, Congenital Tricuspid Valve Atresia, Cyanosis, Drug Exposure During Pregnancy, Haemoglobin Decreased, Haemorrhage, Heart Disease Congenital, Metabolic Acidosis, Oxygen Saturation Decreased, Pericardial Effusion, Pleural Effusion, Pneumomediastinum, Pneumothorax, Postpericardiotomy Syndrome, Pulmonary Valve Stenosis, Respiratory Rate Increased, Right Atrial Dilatation, Right Ventricular Hypertrophy, Ventricular Septal Defect
M 6183334 5672834 02/02/2005 03/19/2008 Paxil CN Anxiety Atrial Septal Defect, Cardiac Murmur, Coagulopathy, Congenital Tricuspid Valve Atresia, Cyanosis, Drug Exposure During Pregnancy, Haemoglobin Decreased, Haemorrhage, Heart Disease Congenital, Metabolic Acidosis, Oxygen Saturation Decreased, Pericardial Effusion, Pleural Effusion, Pneumomediastinum, Pneumothorax, Postpericardiotomy Syndrome, Pulmonary Valve Stenosis, Respiratory Rate Increased, Right Atrial Dilatation, Right Ventricular Hypertrophy, Ventricular Septal Defect
F 6183335 5169981 10/01/2006 12/12/2006 Paxil CR CN Depression Cardiac Disorder, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Heart Disease Congenital
F 6183435 5164317 03/05/2004 11/27/2006 Paxil Anxiety Bronchial Hyperreactivity, Cardiac Failure, Congenital Anomaly, Congenital Diaphragmatic Hernia, Drug Exposure During Pregnancy, Hepatic Failure, Lung Disorder, Pulmonary Hypertension, Ventricular Septal Defect
F 6184132 5171078 10/17/2002 12/13/2006 06/24/2004 Paxil CN Drug Use for Unknown Indication Aortic Disorder, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hypertrophy, Obstructive Airways Disorder, Ventricular Septal Defect
F 6184132 5522174 10/17/2002 11/20/2007 06/24/2004 Paxil PH Drug Use for Unknown Indication Aortic Disorder, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hypertrophy, Liver Disorder, Obstructive Airways Disorder, Post Procedural Complication, Pulmonary Artery Stenosis, Pulmonary Hypertension, Respiratory Disorder, Ventricular Septal Defect
F 6184132 5607954 10/17/2002 01/30/2008 06/24/2004 Paxil PH Drug Use for Unknown Indication Anaemia, Aortic Disorder, Apnoea, Atrial Septal Defect, Bradycardia, Cardiac Murmur, Cerebral Ventricle Dilatation, Cns Ventriculitis, Cyanosis, Drug Exposure During Pregnancy, Fallot's Tetralogy, Foetal Distress Syndrome, Heart Disease Congenital, Hepatomegaly, Hypertrophy, Hypotension, Hypoxia, Intraventricular Haemorrhage, Intraventricular Haemorrhage Neonatal, Liver Disorder, Mitral Valve Incompetence, Obstructive Airways Disorder, Patent Ductus Arteriosus, Post Procedural Complication, Pulmonary Artery Stenosis, Pulmonary Artery Stenosis Congenital, Pulmonary Hypertension, Pulmonary Valve Stenosis Congenital, Respiratory Disorder, Respiratory Distress, Right Ventricular Hypertrophy, Sepsis, Ventricular Septal Defect
F 6184132 5663061 10/17/2002 03/13/2008 06/24/2004 Paxil PH Drug Use for Unknown Indication Anaemia, Aortic Disorder, Apnoea, Atrial Septal Defect, Bradycardia, Cardiac Murmur, Cerebral Ventricle Dilatation, Cns Ventriculitis, Cyanosis, Drug Exposure During Pregnancy, Fallot's Tetralogy, Foetal Distress Syndrome, Heart Disease Congenital, Hepatomegaly, Hypertrophy, Hypotension, Hypoxia, Intraventricular Haemorrhage, Intraventricular Haemorrhage Neonatal, Liver Disorder, Mitral Valve Incompetence, Obstructive Airways Disorder, Patent Ductus Arteriosus, Post Procedural Complication, Pulmonary Artery Stenosis, Pulmonary Artery Stenosis Congenital, Pulmonary Hypertension, Pulmonary Valve Stenosis Congenital, Respiratory Disorder, Respiratory Distress, Right Ventricular Hypertrophy, Sepsis, Ventricular Septal Defect
6186791 5173840 12/14/2006 Paxil MD Schizophrenia Convulsion, Drug Exposure During Pregnancy, Musculoskeletal Stiffness, Myoclonus
F 6189986 5177011 12/18/2006 Paxil CR CN Depression Drug Exposure During Pregnancy, Live Birth, Self-Injurious Ideation, Suicidal Ideation
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6201039 5170524 10/01/1998 12/04/2006 Paroxetine Depression Agitation, Dizziness, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Headache, Insomnia, Irritability, Nausea, Panic Attack, Somnolence, Suicidal Ideation, Vomiting
M 6201495 5190482 12/22/2006 Paxil CN Panic Disorder Death, Drug Exposure During Pregnancy
M 6206476 5195887 01/02/2007 Paxil CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Respiratory Disorder Neonatal
M 6206476 5234451 01/14/2003 02/09/2007 Paxil MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Fontanelle Bulging, Neonatal Tachypnoea, Opisthotonus, Respiratory Disorder Neonatal, Tachypnoea, Vomiting, Vomiting Neonatal
M 6206477 5195888 01/02/2007 Paxil CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Irritability, Respiratory Disorder Neonatal
M 6206477 5234452 02/09/2007 Paxil MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Irritability, Respiratory Disorder Neonatal
F 6206478 5195889 01/02/2007 Paxil CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Respiratory Disorder Neonatal
F 6206478 5234453 09/20/2003 02/09/2007 Paxil MD Abdominal Discomfort, Decreased Activity, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia, Irritability, Neonatal Asphyxia, Neonatal Respiratory Arrest, Respiratory Disorder Neonatal
M 6208396 5198729 12/28/2004 01/04/2007 Paxil CN Drug Use for Unknown Indication Cardiac Disorder, Drug Exposure During Pregnancy, Ventricular Septal Defect
M 6208396 5523314 12/28/2004 11/21/2007 Paxil CR CN Atrial Septal Defect, Bundle Branch Block, Cardiac Disorder, Cardiac Failure Congestive, Cardiac Murmur, Cardiac Ventricular Disorder, Dacryostenosis Acquired, Drug Exposure During Pregnancy, Eating Disorder, Eye Discharge, Hypersomnia, Jaundice, Nasopharyngitis, Respiratory Disorder, Ventricular Hypertrophy, Ventricular Septal Defect, Weight Increased
M 6208396 5532030 12/28/2004 12/03/2007 Paxil CR CN Atrial Septal Defect, Bundle Branch Block, Cardiac Disorder, Cardiac Failure Congestive, Cardiac Murmur, Cardiac Ventricular Disorder, Dacryostenosis Acquired, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Eating Disorder, Eye Discharge, Hypersomnia, Jaundice, Nasopharyngitis, Respiratory Disorder, Ventricular Hypertrophy, Ventricular Septal Defect, Weight Increased
M 6208396 5661686 12/28/2004 03/12/2008 Paxil CR CN Atrial Septal Defect, Bundle Branch Block, Cardiac Disorder, Cardiac Failure Congestive, Cardiac Murmur, Cardiac Ventricular Disorder, Dacryostenosis Acquired, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Eating Disorder, Eye Discharge, Hypersomnia, Jaundice, Nasopharyngitis, Respiratory Disorder, Ventricular Hypertrophy, Ventricular Septal Defect, Weight Increased
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6208396 5677142 12/28/2004 03/24/2008 Paxil CR OT Depression Atrial Septal Defect, Bundle Branch Block, Cardiac Disorder, Cardiac Failure Congestive, Cardiac Murmur, Cardiac Ventricular Disorder, Dacryostenosis Acquired, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Eating Disorder, Eye Discharge, Hypersomnia, Jaundice, Nasopharyngitis, Pulmonary Valve Stenosis, Respiratory Disorder, Ventricular Hypertrophy, Ventricular Septal Defect, Weight Increased
6211034 5202284 01/09/2007 Paroxetine CN Obsessive-Compulsive Disorder Congenital Floppy Infant, Congenital Visual Acuity Reduced, Drug Exposure During Pregnancy
F 6214095 5207193 01/12/2007 Paxil CN Drug Use for Unknown Indication Atrial Septal Defect, Drug Exposure During Pregnancy
F 6214096 5207194 07/21/2005 01/12/2007 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Physical Assault
F 6216938 5210696 01/17/2007 Paxil MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Hyperaesthesia, Hyperventilation
F 6216938 5349292 12/22/2006 06/07/2007 Paxil MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Hyperaesthesia, Hyperventilation, Irritability, Meconium Stain, Respiratory Disorder Neonatal, Tachypnoea
F 6216938 5385540 01/10/2006 07/12/2007 Paxil MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Hyperaesthesia, Hyperventilation, Interstitial Lung Disease, Irritability, Lung Disorder, Meconium Stain, Respiratory Disorder Neonatal, Tachypnoea
F 6221755 5217276 01/24/2007 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy
F 6221877 5217397 01/24/2007 Paxil CR CN Drug Exposure During Pregnancy, Feeling Abnormal, Sensory Disturbance
F 6221884 5217404 01/24/2007 Paxil CR CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Malaise
F 6221898 5217418 01/24/2007 Paxil CR CN Drug Use for Unknown Indication Drug Exposure During Pregnancy
F 6222122 5217608 01/24/2007 Paxil CR CN Depression Depression, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6225365 5207936 01/10/2007 Paroxetine Obsessive-Compulsive Disorder Congenital Floppy Infant, Congenital Visual Acuity Reduced, Drug Exposure During Pregnancy
6228889 5214190 01/12/2007 Paroxetine Congenital Floppy Infant, Congenital Visual Acuity Reduced, Drug Exposure During Pregnancy
F 6229446 5227226 01/01/2006 02/02/2007 11/08/2006 Paroxetine CN Abortion Induced, Cerebral Atrophy, Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy, Nervous System Disorder
M 6230578 5228669 01/01/2006 02/05/2007 Paroxetine MD Drug Exposure During Pregnancy, Foetal Growth Retardation, Premature Baby, Respiratory Tract Infection
F 6231195 5229820 02/06/2007 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy
F 6231195 5340157 02/04/2003 05/31/2007 Paxil LW Drug Use for Unknown Indication Atrial Septal Defect, Atrioventricular Block, Cerebral Infarction, Congenital Anomaly, Convulsion, Drug Exposure During Pregnancy, Left Ventricular Dysfunction, Lung Disorder, Patent Ductus Arteriosus, Pulmonary Valve Stenosis, Transposition of the Great Vessels
F 6231195 5614145 02/04/2003 02/05/2008 Paxil CN Drug Use for Unknown Indication Atrial Septal Defect, Atrioventricular Block, Blood Pressure Abnormal, Cardiac Failure Congestive, Cerebral Infarction, Cerebrovascular Accident, Convulsion, Drug Exposure During Pregnancy, Left Ventricular Dysfunction, Lung Disorder, Mitral Valve Incompetence, Patent Ductus Arteriosus, Pulmonary Valve Stenosis, Transposition of the Great Vessels, Ventricular Septal Defect
6231196 5229822 02/06/2007 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy
6231196 5338681 05/26/2005 05/30/2007 Paxil LW Drug Use for Unknown Indication Atrial Septal Defect, Cardiac Murmur, Congenital Anomaly, Cyanosis, Drug Exposure During Pregnancy, Lethargy, Lung Disorder, Patent Ductus Arteriosus, Respiratory Depth Decreased, Venous Thrombosis, Ventricular Septal Defect
6231197 5229824 02/06/2007 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy
M 6231198 5229826 02/06/2007 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy
M 6231198 5264809 10/08/2005 03/14/2007 Paxil CR CN Drug Use for Unknown Indication Atrial Septal Defect, Blood Pressure Decreased, Cardiac Murmur, Congenital Aortic Anomaly, Congenital Aortic Valve Incompetence, Congenital Foot Malformation, Drug Exposure During Pregnancy, Finger Deformity, Foetal Growth Retardation, Heart Disease Congenital, Hyperbilirubinaemia, Jaundice Neonatal, Limb Malformation, Marfan's Syndrome, Otitis Media, Patent Ductus Arteriosus, Pericardial Effusion
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6231198 5293485 10/08/2005 04/11/2007 Paxil CR CN Drug Use for Unknown Indication Atrial Septal Defect, Blood Pressure Decreased, Cardiac Murmur, Congenital Aortic Anomaly, Congenital Aortic Valve Incompetence, Congenital Foot Malformation, Drug Exposure During Pregnancy, Finger Deformity, Foetal Growth Retardation, Heart Disease Congenital, Hyperbilirubinaemia, Jaundice Neonatal, Limb Malformation, Marfan's Syndrome, Otitis Media, Patent Ductus Arteriosus, Pericardial Effusion
M 6231198 5310019 10/08/2005 04/27/2007 Paxil CR CN Drug Use for Unknown Indication Atrial Septal Defect, Blood Pressure Decreased, Cardiac Murmur, Congenital Aortic Anomaly, Congenital Aortic Valve Incompetence, Congenital Foot Malformation, Drug Exposure During Pregnancy, Finger Deformity, Foetal Growth Retardation, Heart Disease Congenital, Hyperbilirubinaemia, Jaundice Neonatal, Limb Malformation, Macrosomia, Marfan's Syndrome, Otitis Media, Patent Ductus Arteriosus, Pericardial Effusion
M 6231198 5317889 10/08/2005 05/07/2007 Paxil CR CN Drug Use for Unknown Indication Atrial Septal Defect, Blood Pressure Decreased, Cardiac Murmur, Congenital Aortic Anomaly, Congenital Aortic Valve Incompetence, Congenital Foot Malformation, Drug Exposure During Pregnancy, Finger Deformity, Foetal Growth Retardation, Heart Disease Congenital, Hyperbilirubinaemia, Jaundice Neonatal, Limb Malformation, Macrosomia, Marfan's Syndrome, Otitis Media, Patent Ductus Arteriosus, Pericardial Effusion
M 6231198 5327624 10/08/2005 05/17/2007 Paxil CR CN Drug Use for Unknown Indication Atrial Septal Defect, Blood Pressure Decreased, Cardiac Murmur, Congenital Aortic Anomaly, Congenital Aortic Valve Incompetence, Congenital Foot Malformation, Drug Exposure During Pregnancy, Finger Deformity, Foetal Growth Retardation, Heart Disease Congenital, Hyperbilirubinaemia, Jaundice Neonatal, Limb Malformation, Macrosomia, Marfan's Syndrome, Otitis Media, Patent Ductus Arteriosus, Pericardial Effusion
M 6231198 5338682 10/08/2005 05/30/2007 Paxil CR CN Drug Use for Unknown Indication Atrial Septal Defect, Blood Pressure Decreased, Cardiac Murmur, Congenital Aortic Anomaly, Congenital Aortic Valve Incompetence, Congenital Foot Malformation, Drug Exposure During Pregnancy, Finger Deformity, Foetal Growth Retardation, Heart Disease Congenital, Heart Valve Insufficiency, Hyperbilirubinaemia, Jaundice Neonatal, Limb Malformation, Macrosomia, Marfan's Syndrome, Otitis Media, Patent Ductus Arteriosus, Pericardial Effusion
M 6231198 5474740 10/08/2005 10/02/2007 Paxil CR CN Drug Use for Unknown Indication Atrial Septal Defect, Blood Pressure Decreased, Cardiac Murmur, Congenital Aortic Anomaly, Congenital Aortic Valve Incompetence, Congenital Foot Malformation, Drug Exposure During Pregnancy, Finger Deformity, Foetal Growth Retardation, Heart Disease Congenital, Heart Valve Incompetence, Hyperbilirubinaemia, Jaundice Neonatal, Limb Malformation, Macrosomia, Marfan's Syndrome, Otitis Media, Patent Ductus Arteriosus, Pericardial Effusion
M 6231198 5569629 10/08/2005 12/20/2007 Paxil CR CN Drug Use for Unknown Indication Atrial Septal Defect, Blood Pressure Decreased, Cardiac Murmur, Congenital Aortic Anomaly, Congenital Aortic Valve Incompetence, Congenital Foot Malformation, Drug Exposure During Pregnancy, Finger Deformity, Foetal Growth Retardation, Heart Disease Congenital, Heart Valve Incompetence, Hyperbilirubinaemia, Jaundice Neonatal, Limb Malformation, Macrosomia, Marfan's Syndrome, Otitis Media, Patent Ductus Arteriosus, Pericardial Effusion
M 6231198 5618454 10/08/2005 02/07/2008 Paxil CR CN Depression Atrial Septal Defect, Blood Pressure Decreased, Cardiac Murmur, Congenital Aortic Anomaly, Congenital Aortic Valve Incompetence, Congenital Foot Malformation, Drug Exposure During Pregnancy, Finger Deformity, Foetal Growth Retardation, Heart Disease Congenital, Heart Valve Incompetence, Hyperbilirubinaemia, Jaundice Neonatal, Limb Malformation, Macrosomia, Marfan's Syndrome, Otitis Media, Patent Ductus Arteriosus, Pericardial Effusion
F 6231199 5229828 02/06/2007 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy
6231200 5229830 02/06/2007 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy
M 6231200 5345891 07/29/2002 06/05/2007 Paxil CN Drug Use for Unknown Indication Cardiac Murmur, Congenital Anomaly, Drug Exposure During Pregnancy, Oxygen Saturation Decreased, Pleural Effusion, Pneumonia, Respiratory Distress, Transposition of the Great Vessels, Ventricular Septal Defect, Wound Infection
M 6231200 5615598 07/29/2002 02/06/2008 Paxil CN Anxiety Cardiac Murmur, Drug Exposure During Pregnancy, Left Ventricular Dysfunction, Oxygen Saturation Decreased, Pleural Effusion, Pneumonia, Respiratory Distress, Transposition of the Great Vessels, Ventricular Septal Defect, Wound Infection
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6231201 5229832 02/06/2007 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy
F 6231201 5410693 03/28/2005 08/10/2007 Paxil CR CN Depression Congenital Anomaly, Drug Exposure During Pregnancy, Persistent Foetal Circulation, Respiratory Distress
F 6231201 5518237 03/28/2005 11/15/2007 Paxil CR CN Depression Anaemia Neonatal, Anxiety, Aortic Stenosis, Apnoea, Astigmatism, Atrial Septal Defect, Camptodactyly Acquired, Cardiac Murmur, Cognitive Disorder, Cytogenetic Abnormality, Developmental Delay, Drug Exposure During Pregnancy, Dysmorphism, Dysphagia, Dyspnoea, Encephalopathy, Feeding Disorder Neonatal, Foetal Distress Syndrome, Gastrooesophageal Reflux Disease, Grand Mal Convulsion, Hyponatraemia, Hypotonia, Hypoxia, Joint Range of Motion Decreased, Lung Hyperinflation, Micrognathia, Optic Nerve Disorder, Oxygen Saturation Decreased, Pain, Persistent Foetal Circulation, Pneumonia Respiratory Syncytial Viral, Premature Baby, Psychomotor Skills Impaired, Pulmonary Valve Stenosis, Renal Salt-Wasting Syndrome, Respiratory Acidosis, Respiratory Distress, Respiratory Failure, Respiratory Rate Decreased, Sepsis, Speech Disorder Developmental, Staring, Vision Blurred, Visual Disturbance, Williams Syndrome
F 6231201 5620210 03/28/2005 02/08/2008 Paxil CR CN Depression Anaemia Neonatal, Anxiety, Aortic Stenosis, Aortic Valve Incompetence, Apnoea, Astigmatism, Atrial Septal Defect, Camptodactyly Acquired, Cardiac Murmur, Cognitive Disorder, Cytogenetic Abnormality, Developmental Delay, Drug Exposure During Pregnancy, Dysmorphism, Dysphagia, Dyspnoea, Encephalopathy, Failure To Thrive, Feeding Disorder Neonatal, Foetal Distress Syndrome, Foot Deformity, Gastrooesophageal Reflux Disease, Grand Mal Convulsion, Hyponatraemia, Hypotonia, Hypoxia, Joint Range of Motion Decreased, Lung Hyperinflation, Micrognathia, Optic Nerve Disorder, Oxygen Saturation Decreased, Pain, Persistent Foetal Circulation, Pneumonia Respiratory Syncytial Viral, Premature Baby, Psychomotor Skills Impaired, Pulmonary Valve Stenosis, Renal Salt-Wasting Syndrome, Respiratory Acidosis, Respiratory Distress, Respiratory Failure, Respiratory Rate Decreased, Scoliosis, Sepsis, Speech Disorder Developmental, Staring, Vision Blurred, Visual Disturbance, Williams Syndrome
F 6231201 5680418 03/28/2005 03/26/2008 Paxil CR CN Depression Anaemia Neonatal, Anxiety, Aortic Stenosis, Aortic Valve Incompetence, Apnoea, Astigmatism, Atrial Septal Defect, Camptodactyly Acquired, Cardiac Murmur, Cognitive Disorder, Cytogenetic Abnormality, Developmental Delay, Drug Exposure During Pregnancy, Dysmorphism, Dysphagia, Dyspnoea, Encephalopathy, Failure To Thrive, Feeding Disorder Neonatal, Foetal Distress Syndrome, Foot Deformity, Gastrooesophageal Reflux Disease, Grand Mal Convulsion, Hyponatraemia, Hypotonia, Hypoxia, Joint Range of Motion Decreased, Lung Hyperinflation, Microcephaly, Micrognathia, Optic Nerve Disorder, Oxygen Saturation Decreased, Pain, Persistent Foetal Circulation, Pneumonia Respiratory Syncytial Viral, Premature Baby, Psychomotor Skills Impaired, Pulmonary Valve Stenosis, Renal Salt-Wasting Syndrome, Respiratory Acidosis, Respiratory Distress, Respiratory Failure, Respiratory Rate Decreased, Scoliosis, Sepsis, Speech Disorder Developmental, Staring, Vision Blurred, Visual Disturbance, Williams Syndrome
F 6231202 5229834 02/06/2007 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy
F 6231202 5284516 04/04/2002 04/03/2007 Paxil MD Migraine Aortic Valve Incompetence, Apnoea, Arterial Stenosis, Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Arrest, Cardiac Murmur, Cardiomegaly, Cyanosis, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Lung Disorder, Metabolic Acidosis, Mitral Valve Incompetence, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pericardial Effusion, Pilonidal Cyst Congenital, Premature Baby, Respiratory Failure, Sepsis, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Septal Defect
F 6231202 5326327 04/04/2002 05/16/2007 Paxil MD Migraine Aortic Valve Incompetence, Apnoea, Arterial Stenosis, Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Arrest, Cardiac Murmur, Cardiomegaly, Cyanosis, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Lung Disorder, Metabolic Acidosis, Mitral Valve Incompetence, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pericardial Effusion, Pilonidal Cyst Congenital, Premature Baby, Respiratory Failure, Sepsis, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Septal Defect
F 6231202 5333654 04/04/2002 05/24/2007 Paxil MD Migraine Aortic Valve Incompetence, Apnoea, Arterial Stenosis, Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Arrest, Cardiac Murmur, Cardiomegaly, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Fallot's Tetralogy, Heart Disease Congenital, Lung Disorder, Metabolic Acidosis, Mitral Valve Incompetence, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pericardial Effusion, Pilonidal Cyst Congenital, Premature Baby, Respiratory Failure, Sepsis, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Septal Defect
F 6231202 5345892 04/04/2002 06/05/2007 Paxil MD Migraine Aortic Valve Incompetence, Apnoea, Arterial Stenosis, Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Arrest, Cardiac Murmur, Cardiomegaly, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Fallot's Tetralogy, Heart Disease Congenital, Hypotonia, Lung Disorder, Metabolic Acidosis, Mitral Valve Incompetence, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pericardial Effusion, Pilonidal Cyst Congenital, Premature Baby, Respiratory Failure, Sepsis, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Septal Defect
F 6231202 5402662 04/04/2002 08/01/2007 Paxil MD Migraine Aortic Valve Incompetence, Apnoea, Arterial Stenosis, Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Arrest, Cardiac Murmur, Cardiomegaly, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Fallot's Tetralogy, Heart Disease Congenital, Hypotonia, Lung Disorder, Metabolic Acidosis, Mitral Valve Incompetence, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pericardial Effusion, Pilonidal Cyst Congenital, Premature Baby, Respiratory Failure, Sepsis, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Septal Defect
F 6231202 5415513 04/04/2002 08/15/2007 Paxil MD Migraine Aortic Valve Incompetence, Apnoea, Arterial Stenosis, Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Arrest, Cardiac Murmur, Cardiomegaly, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Fallot's Tetralogy, Heart Disease Congenital, Hyperhidrosis, Hypotonia, Lung Disorder, Metabolic Acidosis, Mitral Valve Incompetence, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pericardial Effusion, Pilonidal Cyst Congenital, Premature Baby, Respiratory Failure, Sepsis, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6231202 5688978 04/04/2002 03/31/2008 Paxil MD Migraine Aortic Valve Incompetence, Apnoea, Arterial Stenosis, Atelectasis, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Arrest, Cardiac Murmur, Cardiomegaly, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Fallot's Tetralogy, Heart Disease Congenital, Hyperhidrosis, Hypotonia, Lung Disorder, Metabolic Acidosis, Mitral Valve Incompetence, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pericardial Effusion, Pilonidal Cyst Congenital, Premature Baby, Respiratory Failure, Sepsis, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Septal Defect
F 6231204 5229838 02/06/2007 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
F 6231204 5267253 05/07/2003 03/16/2007 Paxil CN Anxiety Atrial Septal Defect, Congenital Pulmonary Valve Atresia, Congenital Tricuspid Valve Atresia, Congenital Tricuspid Valve Stenosis, Cyanosis, Drug Exposure During Pregnancy, Heart Disease Congenital, Patent Ductus Arteriosus, Pulmonary Valve Stenosis Congenital, Tracheal Stenosis, Tricuspid Valve Incompetence, Ventricular Hypoplasia
F 6231204 5304567 05/07/2003 04/23/2007 Paxil CN Anxiety Atrial Septal Defect, Congenital Pulmonary Valve Atresia, Congenital Tricuspid Valve Atresia, Congenital Tricuspid Valve Stenosis, Cyanosis, Drug Exposure During Pregnancy, Heart Disease Congenital, Patent Ductus Arteriosus, Pulmonary Valve Stenosis Congenital, Tracheal Stenosis, Tricuspid Valve Incompetence, Ventricular Hypoplasia
F 6231204 5316863 05/07/2003 05/04/2007 Paxil CN Anxiety Atrial Septal Defect, Congenital Pulmonary Valve Atresia, Congenital Tricuspid Valve Atresia, Congenital Tricuspid Valve Stenosis, Cyanosis, Drug Exposure During Pregnancy, Heart Disease Congenital, Patent Ductus Arteriosus, Pulmonary Valve Stenosis Congenital, Tracheal Stenosis, Tricuspid Valve Incompetence, Ventricular Hypoplasia
F 6231204 5326329 05/07/2003 05/16/2007 Paxil CN Anxiety Apnoea, Atrial Septal Defect, Congenital Pulmonary Valve Atresia, Congenital Tricuspid Valve Atresia, Congenital Tricuspid Valve Stenosis, Cyanosis, Drug Exposure During Pregnancy, Heart Disease Congenital, Patent Ductus Arteriosus, Pulmonary Valve Stenosis Congenital, Tracheal Stenosis, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Hypoplasia
F 6231204 5338683 05/07/2003 05/30/2007 Paxil CN Anxiety Apnoea, Atrial Septal Defect, Cardiac Murmur, Congenital Pulmonary Valve Atresia, Congenital Tricuspid Valve Atresia, Congenital Tricuspid Valve Stenosis, Cyanosis, Drug Exposure During Pregnancy, Heart Disease Congenital, Patent Ductus Arteriosus, Pulmonary Valve Stenosis Congenital, Tracheal Stenosis, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Hypoplasia
F 6231209 5229848 02/06/2007 Paxil CN Depression Drug Exposure During Pregnancy, Drug Ineffective
F 6231226 5229875 02/06/2007 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
F 6231233 5229882 02/06/2007 Paxil CN Drug Exposure During Pregnancy
F 6231313 5229964 02/06/2007 Paxil CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
6231365 5230020 01/01/2005 02/06/2007 Paxil CN Drug Exposure During Pregnancy, Heart Disease Congenital
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6231368 5230023 02/06/2007 Paxil CN Anxiety, Bradyphrenia, Drug Exposure During Pregnancy, Mood Swings, Off Label Use, Restlessness, Therapeutic Response Unexpected, Tic
F 6231632 5230297 02/06/2007 Paxil CR CN Depression Depressive Symptom, Dizziness, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Headache
F 6231812 5230542 07/01/2003 02/06/2007 Paxil CN Drug Use for Unknown Indication Asthma, Collapse of Lung, Developmental Delay, Drug Exposure During Pregnancy, Respiratory Disorder Neonatal
F 6233747 5233699 06/28/2003 02/08/2007 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Injury
F 6233747 5600079 06/28/2003 01/23/2008 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Injury
F 6234799 5234437 01/01/1999 02/09/2007 Paxil CN Depression Abasia, Developmental Delay, Drug Exposure During Pregnancy, Dyslexia, Enamel Anomaly, Hypotonia, Learning Disability
F 6234799 5314775 01/01/1999 05/02/2007 Paxil CN Abasia, Constipation, Developmental Delay, Drug Exposure During Pregnancy, Dyslexia, Eating Disorder, Enamel Anomaly, Hypotonia, Learning Disability, Vomiting
M 6236203 5235635 10/20/2006 02/12/2007 Paxil CR CN Panic Disorder Ankyloglossia Congenital, Cardiac Murmur, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Heart Disease Congenital, Lactation Disorder, Nasopharyngitis, Wheezing
M 6236203 5377387 10/20/2006 07/03/2007 Paxil CR CN Panic Disorder Ankyloglossia Congenital, Atrial Septal Defect, Cardiac Murmur, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Heart Disease Congenital, Lactation Disorder, Milk Allergy, Nasopharyngitis, Psychomotor Skills Impaired, Wheezing
M 6236203 5389226 10/20/2006 07/17/2007 Paxil CR CN Panic Disorder Ankyloglossia Congenital, Atrial Septal Defect, Cardiac Murmur, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Heart Disease Congenital, Lactation Disorder, Milk Allergy, Nasopharyngitis, Psychomotor Skills Impaired, Wheezing
F 6237277 5237163 04/19/2005 02/13/2007 Seroxat CN Drug Exposure During Pregnancy, Ventricular Septal Defect
F 6237277 5249854 04/19/2005 02/28/2007 Seroxat CN Drug Exposure During Pregnancy, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6237837 5237753 02/05/2004 02/14/2007 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Emotional Distress, Injury, Pain, Ventricular Septal Defect
M 6237837 5502910 08/27/2005 10/31/2007 Paxil CN Panic Attack Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Cyanosis, Decreased Appetite, Dilatation Ventricular, Drug Exposure During Pregnancy, Emotional Distress, Erythema, Haematocrit Decreased, Haemoglobin Decreased, Hearing Impaired, Injury, Left Atrial Dilatation, Motor Dysfunction, Pain, Pneumonia, Pulmonary Valve Stenosis, Red Blood Cell Count Decreased, Respiratory Disorder, Respiratory Failure, Sinus Tachycardia, Speech Disorder, Speech Disorder Developmental, Ventricular Septal Defect, Vomiting
M 6237837 5586980 08/27/2005 01/10/2008 Paxil CN Panic Attack Atrioventricular Block Complete, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Cyanosis, Decreased Appetite, Dilatation Ventricular, Drug Exposure During Pregnancy, Emotional Distress, Erythema, Haematocrit Decreased, Haemoglobin Decreased, Hearing Impaired, Injury, Left Atrial Dilatation, Motor Dysfunction, Pain, Pneumonia, Pulmonary Valve Stenosis, Red Blood Cell Count Decreased, Respiratory Disorder, Respiratory Failure, Sinus Tachycardia, Speech Disorder, Speech Disorder Developmental, Ventricular Septal Defect, Vomiting
M 6237837 5620212 08/27/2005 02/08/2008 Paxil CN Panic Attack Atrioventricular Block Complete, Atrioventricular Block Second Degree, Av Dissociation, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Cyanosis, Decreased Appetite, Dilatation Ventricular, Drug Exposure During Pregnancy, Emotional Distress, Erythema, Haematocrit Decreased, Haemoglobin Decreased, Hearing Impaired, Injury, Left Atrial Dilatation, Motor Dysfunction, Nodal Rhythm, Pain, Pleural Effusion, Pneumonia, Pulmonary Valve Stenosis, Red Blood Cell Count Decreased, Respiratory Disorder, Respiratory Failure, Sinus Tachycardia, Speech Disorder, Speech Disorder Developmental, Supraventricular Extrasystoles, Ventricular Septal Defect, Vomiting
M 6237837 5651009 08/27/2005 03/05/2008 Paxil CN Panic Attack Atrioventricular Block Complete, Atrioventricular Block Second Degree, Av Dissociation, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Cyanosis, Decreased Appetite, Dilatation Ventricular, Drug Exposure During Pregnancy, Emotional Distress, Erythema, Haematocrit Decreased, Haemoglobin Decreased, Hearing Impaired, Injury, Left Atrial Dilatation, Motor Dysfunction, Nodal Rhythm, Pain, Pleural Effusion, Pneumonia, Pulmonary Valve Stenosis, Red Blood Cell Count Decreased, Respiratory Disorder, Respiratory Failure, Sinus Tachycardia, Speech Disorder, Speech Disorder Developmental, Supraventricular Extrasystoles, Ventricular Septal Defect, Vomiting
M 6237837 5669393 08/27/2005 03/17/2008 Paxil CN Panic Attack Atrioventricular Block Complete, Atrioventricular Block Second Degree, Av Dissociation, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Cyanosis, Decreased Appetite, Dilatation Ventricular, Drug Exposure During Pregnancy, Emotional Distress, Erythema, Haematocrit Decreased, Haemoglobin Decreased, Hearing Impaired, Injury, Left Atrial Dilatation, Motor Dysfunction, Nodal Rhythm, Pain, Pleural Effusion, Pneumonia, Pulmonary Valve Stenosis, Red Blood Cell Count Decreased, Respiratory Disorder, Respiratory Failure, Sinus Tachycardia, Speech Disorder, Speech Disorder Developmental, Supraventricular Extrasystoles, Ventricular Septal Defect, Vomiting
M 6237837 5672836 08/27/2005 03/19/2008 Paxil CN Panic Attack Atrioventricular Block Complete, Atrioventricular Block Second Degree, Av Dissociation, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Cyanosis, Decreased Appetite, Dilatation Ventricular, Drug Exposure During Pregnancy, Emotional Distress, Erythema, Haematocrit Decreased, Haemoglobin Decreased, Hearing Impaired, Injury, Left Atrial Dilatation, Motor Dysfunction, Nodal Rhythm, Pain, Pleural Effusion, Pneumonia, Pulmonary Valve Stenosis, Red Blood Cell Count Decreased, Respiratory Disorder, Respiratory Failure, Sinus Tachycardia, Speech Disorder, Speech Disorder Developmental, Supraventricular Extrasystoles, Ventricular Septal Defect, Vomiting
F 6237838 5237754 01/01/2001 02/14/2007 Paxil LW Drug Use for Unknown Indication Congenital Hair Disorder, Congenital Heart Valve Disorder, Deformity Thorax, Drug Exposure During Pregnancy, Emotional Distress, Multiple Congenital Abnormalities, Pain, Pterygium Colli, Ventricular Septal Defect
F 6237838 5505299 01/01/2001 11/02/2007 Paxil OT Anxiety Atrial Septal Defect, Bundle Branch Block Right, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Congenital Hair Disorder, Congenital Heart Valve Disorder, Deformity Thorax, Dilatation Atrial, Dilatation Ventricular, Drug Exposure During Pregnancy, Emotional Distress, Foetal Heart Rate Abnormal, Hepatomegaly, Hyperhidrosis, Mitral Valve Incompetence, Multiple Congenital Abnormalities, Pain, Pleural Effusion, Pterygium Colli, Tachypnoea, Tricuspid Valve Incompetence, Turner's Syndrome, Ventricular Septal Defect
F 6237838 5594764 01/01/2001 01/17/2008 Paxil OT Anxiety Atrial Septal Defect, Bundle Branch Block Right, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Congenital Hair Disorder, Congenital Heart Valve Disorder, Deformity Thorax, Dilatation Atrial, Dilatation Ventricular, Drug Exposure During Pregnancy, Emotional Distress, Foetal Heart Rate Abnormal, Hepatomegaly, Hyperhidrosis, Mitral Valve Incompetence, Multiple Congenital Abnormalities, Pain, Pleural Effusion, Pterygium Colli, Tachypnoea, Tricuspid Valve Incompetence, Turner's Syndrome, Ventricular Septal Defect
F 6237838 5626192 01/01/2001 02/14/2008 Paxil OT Anxiety Atrial Septal Defect, Bundle Branch Block Right, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Congenital Hair Disorder, Congenital Heart Valve Disorder, Deformity Thorax, Dilatation Atrial, Dilatation Ventricular, Drug Exposure During Pregnancy, Emotional Distress, Foetal Heart Rate Abnormal, Hepatomegaly, Hyperhidrosis, Mitral Valve Incompetence, Multiple Congenital Abnormalities, Pain, Pleural Effusion, Pterygium Colli, Tachypnoea, Tricuspid Valve Incompetence, Turner's Syndrome, Ventricular Septal Defect
F 6237838 5630553 01/01/2001 02/19/2008 Paxil OT Anxiety Atrial Septal Defect, Bundle Branch Block Right, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Congenital Hair Disorder, Congenital Heart Valve Disorder, Cyanosis, Deformity Thorax, Dilatation Atrial, Dilatation Ventricular, Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged, Emotional Distress, Foetal Heart Rate Abnormal, Hepatomegaly, Hyperhidrosis, Mitral Valve Incompetence, Multiple Congenital Abnormalities, Pain, Pleural Effusion, Pterygium Colli, Tachypnoea, Tricuspid Valve Incompetence, Turner's Syndrome, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6237838 5663063 01/01/2001 03/13/2008 Paxil OT Anxiety Atrial Septal Defect, Bundle Branch Block Right, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Congenital Hair Disorder, Congenital Heart Valve Disorder, Cyanosis, Deformity Thorax, Dilatation Atrial, Dilatation Ventricular, Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged, Emotional Distress, Foetal Heart Rate Abnormal, Hepatomegaly, Hyperhidrosis, Mitral Valve Incompetence, Multiple Congenital Abnormalities, Pain, Pleural Effusion, Pterygium Colli, Tachypnoea, Tricuspid Valve Incompetence, Turner's Syndrome, Ventricular Septal Defect
F 6237845 5237768 11/13/2003 02/14/2007 Paxil MD Borderline Personality Disorder Asthma, Drug Exposure During Pregnancy, Drug Toxicity
M 6238429 5238515 02/15/2007 Paroxetine CN Depression Drug Exposure During Pregnancy, Melanocytic Naevus, Precancerous Skin Lesion
6241256 5241482 11/01/1994 02/20/2007 Paxil CN Depression Drug Exposure During Pregnancy, Foetal Chromosome Abnormality
F 6241303 5241541 04/27/2003 02/20/2007 Seroxat CN Obsessive-Compulsive Disorder Atrial Septal Defect, Heart Disease Congenital
F 6244113 5245292 02/02/2004 02/23/2007 Paxil LW Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital, Hypoplastic Right Heart Syndrome, Transposition of the Great Vessels, Ventricular Septal Defect
F 6244124 5245302 10/02/2003 02/23/2007 Paxil LW Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation
F 6244124 5463167 10/02/2003 09/20/2007 Paxil LW Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation
F 6244124 5512876 10/02/2003 11/12/2007 Paxil CR PH Drug Use for Unknown Indication Anxiety, Aortic Stenosis, Aortic Valve Incompetence, Bradycardia, Bundle Branch Block Left, Cardiac Murmur, Coarctation of the Aorta, Congenital Anomaly, Developmental Delay, Drug Exposure During Pregnancy, Emotional Disorder, Heart Disease Congenital, Heart Valve Stenosis, Injury, Left Ventricle Outflow Tract Obstruction, Left Ventricular Hypertrophy, Lung Disorder, Pain, Persistent Foetal Circulation, QRS Axis Abnormal, Scar, Sinus Arrhythmia, Speech Disorder Developmental
F 6244124 5591730 10/02/2003 01/15/2008 Paxil CR PH Drug Use for Unknown Indication Anxiety, Aortic Stenosis, Aortic Valve Incompetence, Bradycardia, Bundle Branch Block Left, Cardiac Murmur, Coarctation of the Aorta, Congenital Anomaly, Developmental Delay, Drug Exposure During Pregnancy, Emotional Disorder, Heart Disease Congenital, Heart Valve Stenosis, Injury, Left Ventricle Outflow Tract Obstruction, Left Ventricular Hypertrophy, Lung Disorder, Pain, Persistent Foetal Circulation, QRS Axis Abnormal, Scar, Sinus Arrhythmia, Speech Disorder Developmental
F 6244124 5609562 10/02/2003 01/31/2008 Paxil CR PH Drug Use for Unknown Indication Anhedonia, Anxiety, Aortic Stenosis, Aortic Valve Incompetence, Bradycardia, Bundle Branch Block Left, Cardiac Murmur, Coarctation of the Aorta, Congenital Anomaly, Decreased Appetite, Developmental Delay, Drug Exposure During Pregnancy, Emotional Disorder, Heart Disease Congenital, Heart Valve Stenosis, Injury, Left Ventricle Outflow Tract Obstruction, Left Ventricular Hypertrophy, Lung Disorder, Lung Infiltration, Pain, Persistent Foetal Circulation, Pneumonia, QRS Axis Abnormal, Scar, Sinus Arrhythmia, Speech Disorder Developmental, Staphylococcal Infection, Supraventricular Tachycardia, Tachypnoea, Vomiting
F 6244124 5626193 10/02/2003 02/14/2008 Paxil CR PH Drug Use for Unknown Indication Anxiety, Aortic Stenosis, Aortic Valve Incompetence, Bradycardia, Bundle Branch Block Left, Cardiac Murmur, Cardiomegaly, Coarctation of the Aorta, Cyanosis, Developmental Delay, Drug Exposure During Pregnancy, Emotional Disorder, Heart Disease Congenital, Heart Valve Stenosis, Injury, Left Ventricle Outflow Tract Obstruction, Left Ventricular Hypertrophy, Lung Disorder, Pain, Persistent Foetal Circulation, QRS Axis Abnormal, Respiratory Distress, Scar, Sinus Arrhythmia, Speech Disorder Developmental, Supraventricular Tachycardia, Tachypnoea
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6244124 5656943 10/02/2003 03/10/2008 Paxil CR PH Depression Anxiety, Aortic Valve Incompetence, Bicuspid Aortic Valve, Bradycardia, Bundle Branch Block Left, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Coarctation of the Aorta, Congenital Aortic Stenosis, Congenital Mitral Valve Stenosis, Cyanosis, Developmental Delay, Drug Exposure During Pregnancy, Emotional Disorder, Heart Disease Congenital, Heart Valve Stenosis, Hypertension, Injury, Left Ventricle Outflow Tract Obstruction, Left Ventricular Hypertrophy, Lung Disorder, Pain, Persistent Foetal Circulation, QRS Axis Abnormal, Respiratory Distress, Scar, Sinus Arrhythmia, Speech Disorder Developmental, Supraventricular Tachycardia, Tachypnoea
F 6244125 5245303 03/01/2005 02/23/2007 Paxil LW Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation
F 6244126 5245304 03/18/2004 02/23/2007 Paxil LW Drug Use for Unknown Indication Congenital Anomaly, Congenital Pulmonary Hypertension, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation
F 6244126 5506505 03/18/2004 11/05/2007 Paxil CN Anxiety Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Crepitations, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Fallot's Tetralogy, Fatigue, Heart Rate Increased, Injury, Lung Disorder, Oral Mucosal Discolouration, Pain, Persistent Foetal Circulation, Pleural Effusion, Pulmonary Valve Stenosis, Respiratory Distress, Respiratory Failure, Right Ventricular Hypertrophy, Sinus Bradycardia, Ventricular Septal Defect
F 6244126 5661207 03/18/2004 03/12/2008 Paxil CN Anxiety Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Crepitations, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Fallot's Tetralogy, Fatigue, Heart Rate Increased, Injury, Lung Disorder, Oral Mucosal Discolouration, Pain, Persistent Foetal Circulation, Pleural Effusion, Pulmonary Valve Stenosis, Respiratory Distress, Respiratory Failure, Right Ventricular Hypertrophy, Sinus Bradycardia, Ventricular Septal Defect
F 6244126 5664449 03/18/2004 03/14/2008 Paxil CN Anxiety Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Crepitations, Cyanosis, Decreased Appetite, Drug Exposure During Pregnancy, Fallot's Tetralogy, Fatigue, Heart Rate Increased, Injury, Lung Disorder, Oral Mucosal Discolouration, Pain, Persistent Foetal Circulation, Pleural Effusion, Pulmonary Valve Stenosis, Respiratory Distress, Respiratory Failure, Right Ventricular Hypertrophy, Sinus Bradycardia, Ventricular Septal Defect
M 6245551 5246968 01/16/1996 02/26/2007 Paxil CN Post-Traumatic Stress Disorder Attention Deficit/Hyperactivity Disorder, Diarrhoea, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Learning Disability, Premature Baby, Small for Dates Baby, Underweight, Visual Acuity Reduced, Vomiting
M 6245551 5326331 01/16/1996 05/16/2007 Paxil CN Post-Traumatic Stress Disorder Attention Deficit/Hyperactivity Disorder, Caesarean Section, Diarrhoea, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Learning Disability, Premature Baby, Small for Dates Baby, Underweight, Visual Acuity Reduced, Vomiting
F 6245552 5246970 09/04/2004 02/26/2007 Paxil LW Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation
F 6245552 5532031 09/04/2004 12/03/2007 Paxil CR PH Asthma, Atrial Septal Defect, Blood Glucose Decreased, Bronchial Hyperreactivity, Bronchospasm, Cardiac Murmur, Cough, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Heart Disease Congenital, Increased Bronchial Secretion, Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Pneumonia, Pulmonary Valve Stenosis, Respiratory Distress, Wheezing
F 6245552 5600080 09/04/2004 01/23/2008 Paxil CR PH Asthma, Atrial Septal Defect, Blood Glucose Decreased, Bronchial Hyperreactivity, Bronchospasm, Cardiac Murmur, Cough, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Heart Disease Congenital, Increased Bronchial Secretion, Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Pneumonia, Pulmonary Valve Stenosis, Respiratory Distress, Wheezing
F 6245552 5607955 09/04/2004 01/30/2008 Paxil CR PH Asthma, Atrial Septal Defect, Blood Glucose Decreased, Bronchial Hyperreactivity, Bronchospasm, Cardiac Murmur, Cough, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Heart Disease Congenital, Increased Bronchial Secretion, Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Pneumonia, Pulmonary Valve Stenosis, Respiratory Distress, Wheezing
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 6245552 5642962 09/04/2004 02/28/2008 Paxil CR PH Asthma, Atrial Septal Defect, Blood Glucose Decreased, Bronchial Hyperreactivity, Bronchospasm, Cardiac Murmur, Cough, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Heart Disease Congenital, Increased Bronchial Secretion, Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Pneumonia, Pulmonary Valve Stenosis, Respiratory Distress, Wheezing
F 6245552 5661687 09/04/2004 03/12/2008 Paxil CR PH Asthma, Atrial Septal Defect, Blood Glucose Decreased, Bronchial Hyperreactivity, Bronchospasm, Cardiac Murmur, Cough, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Heart Disease Congenital, Increased Bronchial Secretion, Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Pneumonia, Pulmonary Valve Stenosis, Respiratory Distress, Wheezing
F 6245552 5664447 09/04/2004 03/14/2008 Paxil CR PH Affective Disorder Anhedonia, Anxiety, Asthma, Atrial Septal Defect, Blood Glucose Decreased, Bronchial Hyperreactivity, Bronchospasm, Cardiac Murmur, Cough, Cyanosis, Diarrhoea, Dilatation Ventricular, Drug Exposure During Pregnancy, Dyspnoea, Heart Disease Congenital, Hypoxia, Increased Bronchial Secretion, Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Pneumonia, Pulmonary Valve Stenosis, Respiratory Distress, Upper Respiratory Tract Infection, Vomiting, Wheezing
F 6245552 5672838 09/04/2004 03/19/2008 Paxil CR OT Asthma, Atrial Septal Defect, Blood Glucose Decreased, Bronchial Hyperreactivity, Bronchospasm, Cardiac Murmur, Cough, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Heart Disease Congenital, Increased Bronchial Secretion, Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Pneumonia, Pulmonary Valve Stenosis, Respiratory Distress, Wheezing
F 6245553 5246971 04/16/2002 02/26/2007 Paxil LW Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation
F 6245553 5517106 04/16/2002 11/14/2007 Paxil MD Depression Bundle Branch Block Right, Cardiac Murmur, Congenital Anomaly, Developmental Delay, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Pulmonary Arterial Pressure Increased, Pulmonary Artery Stenosis, Pulmonary Vascular Disorder, Right Ventricular Systolic Pressure Increased, Tachypnoea, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Septal Defect
F 6245553 5653386 04/16/2002 03/06/2008 Paxil OT Depression Bundle Branch Block Right, Cardiac Murmur, Congenital Anomaly, Developmental Delay, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Pulmonary Arterial Pressure Increased, Pulmonary Artery Stenosis, Pulmonary Vascular Disorder, Right Ventricular Systolic Pressure Increased, Tachypnoea, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Septal Defect
F 6245553 5664448 04/16/2002 03/14/2008 Paxil OT Depression Atrial Septal Defect, Bundle Branch Block Right, Cardiac Failure Congestive, Cardiac Murmur, Collapse of Lung, Congenital Anomaly, Developmental Delay, Diaphragmatic Paralysis, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Injury, Lung Disorder, Nerve Injury, Pain, Persistent Foetal Circulation, Pulmonary Arterial Pressure Increased, Pulmonary Artery Stenosis, Pulmonary Haemorrhage, Pulmonary Hypertension, Pulmonary Vascular Disorder, Respiratory Arrest, Respiratory Failure, Right Ventricular Systolic Pressure Increased, Tachypnoea, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Ventricular Septal Defect
M 6245554 5246972 02/25/2004 02/26/2007 Paxil LW Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation
M 6245554 5463168 02/25/2004 09/20/2007 Paxil LW Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation
M 6245554 5510699 02/25/2004 11/08/2007 Paxil CR CN Anxiety Abnormal Behaviour, Aggression, Androgen Deficiency, Autism Spectrum Disorder, Congenital Anomaly, Cryptorchism, Developmental Delay, Drug Exposure During Pregnancy, Febrile Convulsion, Feeding Disorder Neonatal, Foetal Movements Decreased, Growth Retardation, Haemangioma, Heart Disease Congenital, Infertility, Injury, Intentional Self-Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Physical Testicle Examination Abnormal, Premature Baby, Psychomotor Skills Impaired, Speech Disorder Developmental
M 6245554 5579169 02/25/2004 01/02/2008 Paxil CR CN Anxiety Abnormal Behaviour, Aggression, Androgen Deficiency, Autism Spectrum Disorder, Congenital Anomaly, Cryptorchism, Developmental Delay, Drug Exposure During Pregnancy, Febrile Convulsion, Feeding Disorder Neonatal, Foetal Movements Decreased, Growth Retardation, Haemangioma, Heart Disease Congenital, Infertility, Injury, Intentional Self-Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Physical Testicle Examination Abnormal, Plagiocephaly, Premature Baby, Psychomotor Skills Impaired, Speech Disorder Developmental
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6245554 5585504 02/25/2004 01/09/2008 Paxil CR CN Anxiety Abnormal Behaviour, Aggression, Androgen Deficiency, Autism Spectrum Disorder, Congenital Anomaly, Cryptorchism, Developmental Delay, Drug Exposure During Pregnancy, Febrile Convulsion, Feeding Disorder Neonatal, Foetal Movements Decreased, Growth Retardation, Haemangioma, Heart Disease Congenital, Infertility, Injury, Intentional Self-Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Physical Testicle Examination Abnormal, Plagiocephaly, Premature Baby, Psychomotor Skills Impaired, Speech Disorder Developmental
M 6245554 5586983 02/25/2004 01/10/2008 Paxil CR CN Anxiety Abnormal Behaviour, Aggression, Androgen Deficiency, Anhedonia, Anorchism, Anxiety, Autism, Autism Spectrum Disorder, Bronchitis, Conductive Deafness, Congenital Genital Malformation, Cryptorchism, Developmental Delay, Drug Exposure During Pregnancy, Febrile Convulsion, Feeding Disorder Neonatal, Foetal Movements Decreased, Gastroenteritis, Growth Retardation, Haemangioma, Heart Disease Congenital, Infertility, Injury, Intentional Self-Injury, Lung Disorder, Middle Ear Effusion, Pain, Persistent Foetal Circulation, Physical Testicle Examination Abnormal, Plagiocephaly, Premature Baby, Psychomotor Skills Impaired, Sinusitis, Speech Disorder Developmental, Viral Infection
M 6245554 5595737 02/25/2004 01/18/2008 Paxil CR CN Anxiety Abnormal Behaviour, Aggression, Androgen Deficiency, Anorchism, Autism, Autism Spectrum Disorder, Congenital Genital Malformation, Cryptorchism, Developmental Delay, Drug Exposure During Pregnancy, Febrile Convulsion, Feeding Disorder Neonatal, Foetal Movements Decreased, Growth Retardation, Haemangioma, Heart Disease Congenital, Infertility, Injury, Intentional Self-Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Physical Testicle Examination Abnormal, Plagiocephaly, Premature Baby, Psychomotor Skills Impaired, Speech Disorder Developmental
M 6245554 5609564 02/25/2004 01/31/2008 Paxil CR CN Anxiety Abnormal Behaviour, Aggression, Androgen Deficiency, Anorchism, Autism, Autism Spectrum Disorder, Congenital Genital Malformation, Cryptorchism, Developmental Delay, Drug Exposure During Pregnancy, Febrile Convulsion, Feeding Disorder Neonatal, Foetal Movements Decreased, Growth Retardation, Haemangioma, Heart Disease Congenital, Infertility, Injury, Intentional Self-Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Physical Testicle Examination Abnormal, Plagiocephaly, Premature Baby, Psychomotor Skills Impaired, Speech Disorder Developmental
M 6245554 5612560 02/25/2004 02/04/2008 Paxil CR CN Anxiety Abnormal Behaviour, Aggression, Androgen Deficiency, Anorchism, Autism, Autism Spectrum Disorder, Congenital Genital Malformation, Cryptorchism, Developmental Delay, Drug Exposure During Pregnancy, Febrile Convulsion, Feeding Disorder Neonatal, Foetal Movements Decreased, Growth Retardation, Haemangioma, Heart Disease Congenital, Infertility, Injury, Intentional Self-Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Physical Testicle Examination Abnormal, Plagiocephaly, Premature Baby, Psychomotor Skills Impaired, Speech Disorder Developmental
M 6245555 5246973 09/09/1998 02/26/2007 Paxil LW Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation
M 6245555 5532033 09/09/1998 12/03/2007 Paxil PH Drug Use for Unknown Indication Bicuspid Aortic Valve, Cardiac Failure Congestive, Cardiac Murmur, Coarctation of the Aorta, Drug Exposure During Pregnancy, Eating Disorder, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Pulmonary Congestion, Respiratory Distress, Staphylococcal Infection, Transient Tachypnoea of the Newborn, Upper Respiratory Tract Infection
M 6245555 5680419 09/09/1998 03/26/2008 Paxil PH Drug Use for Unknown Indication Bicuspid Aortic Valve, Cardiac Failure Congestive, Cardiac Murmur, Coarctation of the Aorta, Drug Exposure During Pregnancy, Eating Disorder, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation, Pulmonary Congestion, Respiratory Distress, Staphylococcal Infection, Transient Tachypnoea of the Newborn, Upper Respiratory Tract Infection
M 6245556 5246974 10/24/2005 02/26/2007 Paxil LW Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation
M 6245556 5463169 10/24/2005 09/20/2007 Paxil LW Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Lung Disorder, Pain, Persistent Foetal Circulation
M 6245556 5518239 10/24/2005 11/15/2007 Paxil CR PH Drug Use for Unknown Indication Atrial Septal Defect, Chronic Respiratory Failure, Colitis Ischaemic, Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Interruption of Aortic Arch, Lung Disorder, Pain, Patent Ductus Arteriosus, Persistent Foetal Circulation, Ventricular Septal Defect
M 6245556 5609566 10/24/2005 01/31/2008 Paxil CR PH Anxiety Atrial Septal Defect, Chronic Respiratory Failure, Colitis Ischaemic, Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Interruption of Aortic Arch, Lung Disorder, Pain, Patent Ductus Arteriosus, Persistent Foetal Circulation, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6245556 5680420 10/24/2005 03/26/2008 Paxil CR PH Anxiety Atrial Septal Defect, Chronic Respiratory Failure, Colitis Ischaemic, Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Injury, Interruption of Aortic Arch, Lung Disorder, Pain, Patent Ductus Arteriosus, Persistent Foetal Circulation, Ventricular Septal Defect
F 6246411 5248096 07/01/2005 02/27/2007 07/01/2005 Paxil CN Drug Use for Unknown Indication Death Neonatal, Heart Rate Decreased, Neonatal Disorder
M 6254659 5247300 03/09/2004 02/23/2007 Paxil CR Depression Drug Exposure During Pregnancy, Dyspnoea, Gastrooesophageal Reflux Disease, Neonatal Disorder, Transposition of the Great Vessels
F 6256985 5248652 10/13/1999 02/26/2007 Paxil Anxiety, Condition Aggravated, Depression, Drug Exposure During Pregnancy, Scar, Self Mutilation, Suicidal Ideation
6259234 5262773 03/12/2007 Paroxetine OT Major Depression Drug Exposure During Pregnancy, Heart Disease Congenital
M 6259234 5266204 04/23/2001 03/15/2007 Paxil OT Major Depression Drug Exposure During Pregnancy, Fallot's Tetralogy, Lung Disorder, Solitary Kidney, Truncus Arteriosus Persistent
M 6259843 5254736 07/25/2006 02/28/2007 Paroxetine CN Depression Drug Exposure During Pregnancy, Melanocytic Naevus, Wound Infection
M 6266513 5271068 01/17/2004 03/21/2007 Paxil CN Drug Exposure During Pregnancy, Talipes
M 6268981 5273971 03/23/2007 10/01/2001 Paxil CN Depression Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy, Foetal Heart Rate Abnormal, Intra-Uterine Death, Talipes
M 6271906 5277087 03/27/2007 Paxil CN Drug Use for Unknown Indication Death, Drug Exposure During Pregnancy, Injury
6271908 5277090 03/27/2007 Paxil LW Drug Use for Unknown Indication Death, Drug Exposure During Pregnancy, Injury
6271909 5277091 03/27/2007 Paxil LW Drug Use for Unknown Indication Death, Drug Exposure During Pregnancy, Injury
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6271909 5554241 09/26/2003 12/13/2007 03/12/2005 Paxil OT Depression Blood Bicarbonate Increased, Breath Sounds Abnormal, Bronchospasm, Cardiac Failure Congestive, Cardiac Murmur, Congenital Anomaly, Congenital Pulmonary Artery Anomaly, Developmental Delay, Drug Exposure During Pregnancy, Dyspnoea, Eating Disorder, Gastrooesophageal Reflux Disease, Head Titubation, Heart Disease Congenital, High-Pitched Crying, Hypospadias, Hypoventilation, Injury, Intercostal Retraction, Lung Disorder, Nasal Flaring, Oxygen Saturation Decreased, Pneumonia Primary Atypical, Psychomotor Skills Impaired, Pulmonary Artery Dilatation, Pulmonary Hypoplasia, Pyelectasia, Respiratory Arrest, Respiratory Distress, Respiratory Rate Increased, Rib Deformity, Spinal Deformity, Stridor, Ventricular Septal Defect
M 6271909 5583006 09/26/2003 01/07/2008 03/12/2005 Paxil OT Depression Blood Bicarbonate Increased, Breath Sounds Abnormal, Bronchospasm, Cardiac Failure Congestive, Cardiac Murmur, Congenital Anomaly, Congenital Pulmonary Artery Anomaly, Developmental Delay, Drug Exposure During Pregnancy, Dyspnoea, Eating Disorder, Gastrooesophageal Reflux Disease, Head Titubation, Heart Disease Congenital, High-Pitched Crying, Hypospadias, Hypoventilation, Injury, Intercostal Retraction, Lung Disorder, Nasal Flaring, Oxygen Saturation Decreased, Pneumonia Primary Atypical, Psychomotor Skills Impaired, Pulmonary Artery Dilatation, Pulmonary Hypoplasia, Pyelocaliectasis, Respiratory Arrest, Respiratory Distress, Respiratory Rate Increased, Rib Deformity, Spinal Deformity, Stridor, Ventricular Septal Defect
M 6271909 5614146 09/26/2003 02/05/2008 03/12/2005 Paxil OT Depression Anaemia, Apnoea, Blood Bicarbonate Increased, Breath Sounds Abnormal, Bronchospasm, Cardiac Failure Congestive, Cardiac Murmur, Congenital Pulmonary Artery Anomaly, Cyanosis, Developmental Delay, Drug Exposure During Pregnancy, Dyspnoea, Eating Disorder, Gastrooesophageal Reflux Disease, Head Titubation, Heart Disease Congenital, High-Pitched Crying, Hypercapnia, Hypospadias, Hypoventilation, Injury, Intercostal Retraction, Lung Disorder, Nasal Flaring, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pleural Effusion, Pneumonia Primary Atypical, Psychomotor Skills Impaired, Pulmonary Artery Dilatation, Pulmonary Hypertension, Pulmonary Hypoplasia, Pyelocaliectasis, Pyrexia, Respiratory Arrest, Respiratory Distress, Respiratory Failure, Respiratory Rate Increased, Respiratory Syncytial Virus Bronchiolitis, Respiratory Tract Infection, Rib Deformity, Right Ventricular Hypertrophy, Spinal Deformity, Stridor, Tracheomalacia, Tricuspid Valve Incompetence, Urinary Tract Infection, Ventricular Septal Defect
M 6271909 5656944 09/26/2003 03/10/2008 03/12/2005 Paxil OT Depression Anaemia, Apnoea, Blood Bicarbonate Increased, Breath Sounds Abnormal, Bronchospasm, Cardiac Failure Congestive, Cardiac Murmur, Congenital Pulmonary Artery Anomaly, Cyanosis, Developmental Delay, Drug Exposure During Pregnancy, Dyspnoea, Eating Disorder, Gastrooesophageal Reflux Disease, Head Titubation, Heart Disease Congenital, High-Pitched Crying, Hypercapnia, Hypospadias, Hypoventilation, Injury, Intercostal Retraction, Lung Disorder, Nasal Flaring, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pleural Effusion, Pneumonia Primary Atypical, Psychomotor Skills Impaired, Pulmonary Artery Dilatation, Pulmonary Hypertension, Pulmonary Hypoplasia, Pyelocaliectasis, Pyrexia, Respiratory Arrest, Respiratory Distress, Respiratory Failure, Respiratory Rate Increased, Respiratory Syncytial Virus Bronchiolitis, Respiratory Tract Infection, Rib Deformity, Right Ventricular Hypertrophy, Spinal Deformity, Stridor, Tracheomalacia, Tricuspid Valve Incompetence, Urinary Tract Infection, Ventricular Septal Defect
M 6271909 5682807 09/26/2003 03/27/2008 03/12/2005 Paxil OT Depression Anaemia, Apnoea, Blood Bicarbonate Increased, Breath Sounds Abnormal, Bronchospasm, Cardiac Failure Congestive, Cardiac Murmur, Congenital Pulmonary Artery Anomaly, Cyanosis, Developmental Delay, Drug Exposure During Pregnancy, Dyspnoea, Eating Disorder, Gastrooesophageal Reflux Disease, Head Titubation, Heart Disease Congenital, High-Pitched Crying, Hypercapnia, Hypospadias, Hypoventilation, Injury, Intercostal Retraction, Lung Disorder, Nasal Flaring, Oxygen Saturation Decreased, Patent Ductus Arteriosus, Pleural Effusion, Pneumonia Primary Atypical, Psychomotor Skills Impaired, Pulmonary Artery Dilatation, Pulmonary Hypertension, Pulmonary Hypoplasia, Pyelocaliectasis, Pyrexia, Respiratory Arrest, Respiratory Distress, Respiratory Failure, Respiratory Rate Increased, Respiratory Syncytial Virus Bronchiolitis, Respiratory Tract Infection, Rib Deformity, Right Ventricular Hypertrophy, Spinal Deformity, Stridor, Tracheomalacia, Tricuspid Valve Incompetence, Urinary Tract Infection, Ventricular Septal Defect
M 6271912 5277094 03/27/2007 Paxil CN Drug Use for Unknown Indication Asthma, Bronchopulmonary Dysplasia, Cerebral Haemorrhage, Drug Exposure During Pregnancy, Heart Disease Congenital, Immune System Disorder, Lung Disorder, Patent Ductus Arteriosus, Persistent Foetal Circulation, Pneumonia
M 6271912 5452872 04/20/2002 09/14/2007 Paxil LW Drug Use for Unknown Indication Asthma, Bronchopulmonary Dysplasia, Cerebral Haemorrhage, Deafness, Drug Exposure During Pregnancy, Heart Disease Congenital, Hernia, Immune System Disorder, Lung Disorder, Patent Ductus Arteriosus, Persistent Foetal Circulation, Pneumonia, Visual Disturbance, Vocal Cord Disorder
M 6271912 5623098 04/20/2002 02/12/2008 Paxil OT Drug Use for Unknown Indication Asthma, Bronchopulmonary Dysplasia, Cerebral Haemorrhage, Convulsion, Deafness Neurosensory, Drug Exposure During Pregnancy, Heart Disease Congenital, Hernia, Immune System Disorder, Lung Disorder, Migraine, Patent Ductus Arteriosus, Persistent Foetal Circulation, Pneumonia, Premature Baby, Speech Disorder Developmental, Visual Disturbance, Vocal Cord Disorder
M 6271912 5651012 04/20/2002 03/05/2008 Paxil OT Depression Asthma, Bronchopulmonary Disease, Bronchopulmonary Dysplasia, Cerebral Haemorrhage, Convulsion, Deafness Neurosensory, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Heart Disease Congenital, Hernia, Immune System Disorder, Laryngeal Web, Lung Disorder, Mental Disorder, Migraine, Pain, Patent Ductus Arteriosus, Persistent Foetal Circulation, Pneumonia, Premature Baby, Speech Disorder Developmental, Visual Disturbance, Vocal Cord Disorder
M 6271912 5672840 04/20/2002 03/19/2008 Paxil OT Depression Asthma, Bronchopulmonary Disease, Bronchopulmonary Dysplasia, Cerebral Haemorrhage, Convulsion, Deafness Neurosensory, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Heart Disease Congenital, Hernia, Immune System Disorder, Laryngeal Web, Lung Disorder, Mental Disorder, Migraine, Pain, Patent Ductus Arteriosus, Persistent Foetal Circulation, Pneumonia, Premature Baby, Speech Disorder Developmental, Visual Disturbance, Vocal Cord Disorder
M 6271912 5674634 04/20/2002 03/20/2008 Paxil OT Depression Asthma, Bronchopulmonary Disease, Bronchopulmonary Dysplasia, Cerebral Haemorrhage, Convulsion, Deafness Neurosensory, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Heart Disease Congenital, Hernia, Immune System Disorder, Laryngeal Web, Lung Disorder, Mental Disorder, Migraine, Pain, Patent Ductus Arteriosus, Persistent Foetal Circulation, Pneumonia, Premature Baby, Speech Disorder Developmental, Visual Disturbance, Vocal Cord Disorder
F 6272024 5277263 01/01/2002 03/27/2007 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Premature Labour, Premature Separation of Placenta
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6273182 5278601 05/08/2004 03/28/2007 Paxil CN Drug Use for Unknown Indication Cardiac Disorder, Congenital Anomaly, Drug Exposure During Pregnancy, Transposition of the Great Vessels
M 6273182 5520827 05/08/2004 11/19/2007 Paxil OT Drug Use for Unknown Indication Cardiac Disorder, Congenital Anomaly, Drug Exposure During Pregnancy, Transposition of the Great Vessels, Ventricular Septal Defect
M 6273182 5604305 05/08/2004 01/28/2008 Paxil OT Drug Use for Unknown Indication Cardiac Disorder, Congenital Anomaly, Cyanosis, Deep Vein Thrombosis, Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital, Hypoxia, Respiratory Depth Decreased, Transposition of the Great Vessels, Ventricular Septal Defect
6277299 5283228 05/29/2006 04/02/2007 Paxil MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Respiratory Failure
M 6284411 5292131 10/17/2004 04/10/2007 02/11/2005 Paxil LW Drug Use for Unknown Indication Anhedonia, Anxiety, Congenital Anomaly, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy, Heart Injury, Injury, Pain, Scar
M 6284411 5506506 10/17/2004 11/05/2007 02/11/2005 Paxil CR LW Depression Atrial Septal Defect, Cardiomegaly, Coagulopathy, Coarctation of the Aorta, Congenital Anomaly, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy, Heart Injury, Heart Valve Incompetence, Hepatic Cirrhosis, Hepatic Failure, Hepatomegaly, Hypoplastic Left Heart Syndrome, Injury, Metabolic Acidosis, Pain, Patent Ductus Arteriosus, Pulmonary Oedema, Renal Failure, Respiratory Distress, Respiratory Failure, Scar, Ventricular Hypoplasia
M 6284411 5661209 10/17/2004 03/12/2008 02/11/2005 Paxil CR LW Depression Atrial Septal Defect, Cardiomegaly, Coagulopathy, Coarctation of the Aorta, Congenital Anomaly, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy, Heart Injury, Heart Valve Incompetence, Hepatic Cirrhosis, Hepatic Failure, Hepatomegaly, Hypoplastic Left Heart Syndrome, Injury, Metabolic Acidosis, Pain, Patent Ductus Arteriosus, Pulmonary Oedema, Renal Failure, Respiratory Distress, Respiratory Failure, Scar, Ventricular Hypoplasia
M 6284427 5292154 04/10/2007 Paxil MD Drug Exposure During Pregnancy, Intercostal Retraction, Irritability, Respiration Abnormal, Respiratory Disorder Neonatal
M 6284427 5299104 02/28/2006 04/17/2007 Paxil MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Intercostal Retraction, Irritability, Respiration Abnormal, Respiratory Disorder Neonatal, Tachypnoea
M 6284427 5302099 02/28/2006 04/19/2007 Paxil MD Acidosis, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Intercostal Retraction, Irritability, Respiration Abnormal, Respiratory Disorder Neonatal, Tachypnoea
M 6284427 5305915 02/28/2006 04/24/2007 Paxil MD Acidosis, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Intercostal Retraction, Irritability, Respiration Abnormal, Respiratory Disorder Neonatal, Tachypnoea
M 6285118 5282598 03/26/2007 Paxil Drug Exposure During Pregnancy, Oligohydramnios, Premature Baby
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6285141 5282599 03/26/2007 Paxil Congenital Cerebral Cyst, Drug Exposure During Pregnancy, Haemorrhagic Cyst, Head Circumference Abnormal, Neonatal Disorder, Premature Baby
M 6285177 5282814 02/20/2002 03/29/2007 Paxil Anxiety, Depression Anal Atresia, Drug Exposure During Pregnancy
M 6286498 5294608 04/12/2007 Paxil CN Drug Use for Unknown Indication Cardiac Disorder, Drug Exposure During Pregnancy, Heart Disease Congenital
M 6287737 5296190 04/13/2007 Paxil CN Drug Use for Unknown Indication Death, Drug Exposure During Pregnancy, Injury
M 6287737 5512877 11/27/2004 11/12/2007 04/06/2005 Paxil OT Depression Apnoea, Asplenia, Atrial Septal Defect, Cardiac Failure Congestive, Cardiac Valve Disease, Cardiomegaly, Congenital Cardiovascular Anomaly, Cyanosis, Drug Exposure During Pregnancy, Haemorrhage, Heart Disease Congenital, Metabolic Acidosis, Oedema, Oxygen Saturation Decreased, Pulmonary Oedema, Pulmonary Vein Stenosis, Situs Inversus, Transposition of the Great Vessels, Ventricular Arrhythmia
M 6287737 5519516 11/27/2004 11/16/2007 04/06/2005 Paxil OT Depression Apnoea, Asplenia, Atrial Septal Defect, Cardiac Failure Congestive, Cardiac Valve Disease, Cardiomegaly, Congenital Cardiovascular Anomaly, Cyanosis, Drug Exposure During Pregnancy, Haemorrhage, Heart Disease Congenital, Metabolic Acidosis, Oedema, Oxygen Saturation Decreased, Pulmonary Oedema, Pulmonary Vein Stenosis, Situs Inversus, Transposition of the Great Vessels, Ventricular Arrhythmia
M 6287737 5621933 11/27/2004 02/11/2008 04/06/2005 Paxil OT Depression Apnoea, Asplenia, Atrial Septal Defect, Cardiac Failure Congestive, Cardiac Valve Disease, Cardiomegaly, Congenital Cardiovascular Anomaly, Cyanosis, Drug Exposure During Pregnancy, Haemorrhage, Heart Disease Congenital, Metabolic Acidosis, Oedema, Oxygen Saturation Decreased, Pulmonary Oedema, Pulmonary Vein Stenosis, Situs Inversus, Transposition of the Great Vessels, Ventricular Arrhythmia
M 6287737 5669395 11/27/2004 03/17/2008 04/06/2005 Paxil OT Depression Apnoea, Asplenia, Atrial Septal Defect, Cardiac Failure Congestive, Cardiac Valve Disease, Cardiomegaly, Congenital Cardiovascular Anomaly, Cyanosis, Drug Exposure During Pregnancy, Haemorrhage, Heart Disease Congenital, Metabolic Acidosis, Oedema, Oxygen Saturation Decreased, Pulmonary Oedema, Pulmonary Vein Stenosis, Situs Inversus, Transposition of the Great Vessels, Ventricular Arrhythmia
6287738 5296191 04/13/2007 Paxil CN Drug Use for Unknown Indication Death, Drug Exposure During Pregnancy, Injury
M 6288951 5297956 10/03/2005 04/16/2007 Seroxat CN Depression Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Psychomotor Skills Impaired, Restlessness
M 6288951 5387734 10/03/2005 07/16/2007 Seroxat CN Depression Developmental Delay, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Irritability, Psychomotor Skills Impaired, Restlessness
F 6292908 5303283 04/20/2007 Paxil CN Depression Arrhythmia, Cardiac Murmur, Drug Exposure During Pregnancy, Heart Disease Congenital, Psychomotor Hyperactivity
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
6294248 5304578 04/23/2007 Paxil CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Heart Disease Congenital
6296836 5300033 05/29/2006 04/10/2007 Paxil MD Depression Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Respiratory Failure
F 6298357 5651013 04/02/2003 03/05/2008 Paxil CN Drug Use for Unknown Indication Abdominal Transposition, Aorta Hypoplasia, Aortic Stenosis, Aspiration, Asplenia, Atelectasis, Atrial Septal Defect, Bradycardia, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Coarctation of the Aorta, Drug Exposure During Pregnancy, Hypotension, Inferior Vena Caval Occlusion, Infusion Site Extravasation, Intestinal Malrotation, Patent Ductus Arteriosus, Pulmonary Oedema, Right Ventricular Hypertrophy, Sinus Bradycardia, Situs Ambiguous, Thermal Burn, Vocal Cord Paralysis
F 6301698 5313825 10/05/1999 05/01/2007 Paxil CN Depression Attention Deficit/Hyperactivity Disorder, Cardiac Murmur, Drug Exposure During Pregnancy, Fallot's Tetralogy, Trichotillomania
M 6302599 5314789 01/01/1999 05/02/2007 Paxil CN Depression Cardiac Disorder, Drug Exposure During Pregnancy, Heart Disease Congenital, Learning Disorder
6302860 5306427 04/17/2007 Paroxetine MD Drug Exposure During Pregnancy, Patent Ductus Arteriosus
M 6307777 5314228 02/28/2006 04/26/2007 Paxil MD Drug Use for Unknown Indication Acidosis, Blood Gases Abnormal, Blood PH Decreased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Haematemesis, Haemoptysis, Intercostal Retraction, Irritability, Nasal Disorder, Neonatal Tachypnoea, Nicotine Dependence, Respiratory Disorder Neonatal, Restlessness
M 6307777 5333697 01/01/2006 05/24/2007 Paxil MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyspnoea, Haemoptysis, Intercostal Retraction, Irritability, Jaundice Neonatal, Neonatal Respiratory Acidosis, Pulmonary Haemorrhage, Respiration Abnormal, Respiratory Disorder Neonatal, Restlessness, Tachypnoea, Transient Tachypnoea of the Newborn
M 6307800 5320217 05/09/2007 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Cyanosis, Death, Drug Exposure During Pregnancy, Dyspnoea, Persistent Foetal Circulation
M 6307800 5640858 08/30/2004 02/27/2008 10/17/2004 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Persistent Foetal Circulation
M 6307800 5642964 08/30/2004 02/28/2008 10/17/2004 Paxil CN Drug Use for Unknown Indication Congenital Anomaly, Cyanosis, Drug Exposure During Pregnancy, Dyspnoea, Persistent Foetal Circulation
M 6307838 5314231 12/19/2004 04/26/2007 Paxil MD Bipolar Disorder Apgar Score Low, Areflexia, Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Neonatal Asphyxia, Neonatal Disorder, Respiratory Disorder Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6311172 5323805 03/13/2006 05/14/2007 Paxil LW Drug Exposure During Pregnancy, Fallot's Tetralogy, Pulmonary Hypertension, Pulmonary Valve Stenosis, Ventricular Septal Defect
M 6311172 5463172 03/13/2006 09/20/2007 Paxil LW Drug Exposure During Pregnancy, Fallot's Tetralogy, Pulmonary Hypertension, Pulmonary Valve Stenosis, Ventricular Septal Defect
M 6311172 5630556 11/14/2005 02/19/2008 Paroxetine PH Depression Aortic Valve Incompetence, Atrial Septal Defect, Bronchiolitis, Cardiac Murmur, Cardiomegaly, Cyanosis, Dehydration, Diarrhoea, Drug Exposure During Pregnancy, Fallot's Tetralogy, Foetal Macrosomia, Hypoxia, Jaundice Neonatal, Lobar Pneumonia, Metabolic Acidosis, Neonatal Disorder, Oxygen Saturation Decreased, Pulmonary Artery Stenosis Congenital, Pulmonary Hypertension, Pulmonary Valve Stenosis, Right Ventricular Hypertrophy, Shoulder Dystocia, Thrombocythaemia, Tricuspid Valve Incompetence, Upper Respiratory Tract Infection, Ventricular Septal Defect, Vomiting
F 6311173 5323806 05/27/2003 05/14/2007 Paxil LW Anomalous Pulmonary Venous Connection, Atrial Septal Defect, Drug Exposure During Pregnancy, Hypoxia
F 6311173 5502911 05/27/2003 10/31/2007 Paxil MD Abdominal Distension, Abnormal Faeces, Acidosis, Anomalous Pulmonary Venous Connection, Aorta Hypoplasia, Atrial Septal Defect, Atrial Tachycardia, Autism, Cardiomegaly, Chylothorax, Cyanosis, Diarrhoea, Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged, Emphysema, Hypotension, Hypoxia, Nephroblastoma, Obstructive Airways Disorder, Patent Ductus Arteriosus, Pneumothorax, Pulmonary Hypertension, Pulmonary Oedema, Respiratory Failure, Right Ventricular Failure, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Vomiting, Wheezing
F 6311173 5576489 05/27/2003 12/28/2007 Paxil OT Abdominal Distension, Abnormal Faeces, Acidosis, Anomalous Pulmonary Venous Connection, Aorta Hypoplasia, Atrial Septal Defect, Atrial Tachycardia, Autism, Cardiomegaly, Chylothorax, Cyanosis, Diarrhoea, Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged, Emphysema, Hypotension, Hypoxia, Nephroblastoma, Obstructive Airways Disorder, Patent Ductus Arteriosus, Pneumothorax, Pulmonary Hypertension, Pulmonary Oedema, Respiratory Failure, Right Ventricular Failure, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Vomiting, Wheezing
F 6311173 5588666 05/27/2003 01/11/2008 Paxil OT Abdominal Distension, Abnormal Faeces, Acidosis, Anomalous Pulmonary Venous Connection, Aorta Hypoplasia, Atrial Septal Defect, Atrial Tachycardia, Autism, Cardiac Failure, Cardiomegaly, Chylothorax, Cyanosis, Diarrhoea, Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged, Emphysema, Hypotension, Hypoxia, Nephroblastoma, Obstructive Airways Disorder, Patent Ductus Arteriosus, Pneumothorax, Pulmonary Hypertension, Pulmonary Oedema, Respiratory Failure, Right Ventricular Failure, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Vomiting, Wheezing
F 6311173 5597558 05/27/2003 01/21/2008 Paxil OT Abdominal Distension, Abnormal Faeces, Acidosis, Anomalous Pulmonary Venous Connection, Anoxic Encephalopathy, Aorta Hypoplasia, Atrial Septal Defect, Atrial Tachycardia, Autism, Bacteraemia, Cardiac Failure, Cardiomegaly, Chylothorax, Cyanosis, Developmental Delay, Diarrhoea, Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged, Emphysema, Hypotension, Hypoxia, Nephroblastoma, Neutropenia, Obstructive Airways Disorder, Patent Ductus Arteriosus, Pneumothorax, Pulmonary Hypertension, Pulmonary Oedema, Pyrexia, Respiratory Failure, Right Ventricular Failure, Speech Disorder Developmental, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Vomiting, Wheezing
F 6311173 5624656 05/27/2003 02/13/2008 Paxil OT Abdominal Distension, Abnormal Faeces, Acidosis, Anomalous Pulmonary Venous Connection, Anoxic Encephalopathy, Aorta Hypoplasia, Atrial Septal Defect, Atrial Tachycardia, Autism, Bacteraemia, Cardiac Failure, Cardiomegaly, Chylothorax, Cyanosis, Developmental Delay, Diarrhoea, Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged, Emphysema, Hypotension, Hypoxia, Nephroblastoma, Neutropenia, Obstructive Airways Disorder, Patent Ductus Arteriosus, Pneumothorax, Pulmonary Hypertension, Pulmonary Oedema, Pyrexia, Respiratory Failure, Right Ventricular Failure, Speech Disorder Developmental, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Vomiting, Wheezing
F 6311173 5626194 05/27/2003 02/14/2008 Paxil OT Abdominal Distension, Abnormal Faeces, Acidosis, Anomalous Pulmonary Venous Connection, Anoxic Encephalopathy, Aorta Hypoplasia, Atrial Septal Defect, Atrial Tachycardia, Autism, Bacteraemia, Cardiac Failure, Cardiomegaly, Chylothorax, Cyanosis, Developmental Delay, Diarrhoea, Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged, Emphysema, Hypotension, Hypoxia, Nephroblastoma, Neutropenia, Obstructive Airways Disorder, Patent Ductus Arteriosus, Pneumothorax, Pulmonary Hypertension, Pulmonary Oedema, Pyrexia, Respiratory Distress, Respiratory Failure, Right Ventricular Failure, Speech Disorder Developmental, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Vomiting, Wheezing
F 6311173 5653387 05/27/2003 03/06/2008 Paxil OT Anxiety Abdominal Distension, Abnormal Faeces, Acidosis, Aggression, Anger, Anomalous Pulmonary Venous Connection, Anoxic Encephalopathy, Aorta Hypoplasia, Atrial Septal Defect, Atrial Tachycardia, Autism, Bacteraemia, Cardiac Failure, Cardiomegaly, Chylothorax, Cyanosis, Developmental Delay, Diarrhoea, Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged, Emphysema, Hypotension, Hypoxia, Nephroblastoma, Neutropenia, Obstructive Airways Disorder, Patent Ductus Arteriosus, Pneumothorax, Pulmonary Hypertension, Pulmonary Oedema, Pyrexia, Respiratory Distress, Respiratory Failure, Right Ventricular Failure, Speech Disorder Developmental, Tricuspid Valve Incompetence, Ventricular Hypertrophy, Vomiting, Wheezing
M 6319488 5333673 06/24/2004 05/24/2007 12/12/2005 Paxil CR CN Congenital Pulmonary Valve Disorder, Death, Drug Exposure During Pregnancy, Fallot's Tetralogy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6319488 5563043 06/24/2004 12/17/2007 12/12/2005 Paxil CN Maternal Condition Affecting Foetus Atelectasis, Atrial Septal Defect, Atrioventricular Block, Bronchospasm, Cardio-Respiratory Arrest, Congenital Pulmonary Valve Disorder, Dacryostenosis Acquired, Deafness, Developmental Delay, DiGeorge's Syndrome, Drug Exposure During Pregnancy, Eye Discharge, Fallot's Tetralogy, Gastrooesophageal Reflux Disease, Hypotonia, Microcephaly, Oxygen Saturation Decreased, Pallor, Patent Ductus Arteriosus, Pneumonia, Pulmonary Artery Dilatation, T-Lymphocyte Count Decreased, Underweight, Velo-Cardio-facial Syndrome
M 6319488 5609569 06/24/2004 01/31/2008 12/12/2005 Paxil CN Atelectasis, Atrial Septal Defect, Atrioventricular Block, Bronchospasm, Cardio-Respiratory Arrest, Congenital Pulmonary Valve Disorder, Dacryostenosis Acquired, Deafness, Developmental Delay, DiGeorge's Syndrome, Drug Exposure During Pregnancy, Eye Discharge, Fallot's Tetralogy, Gastrooesophageal Reflux Disease, Hypotonia, Microcephaly, Oxygen Saturation Decreased, Pallor, Patent Ductus Arteriosus, Pneumonia, Pulmonary Artery Dilatation, T-Lymphocyte Count Decreased, Underweight, Velo-Cardio-facial Syndrome
M 6319488 5669397 06/24/2004 03/17/2008 12/12/2005 Paxil CN Atelectasis, Atrial Septal Defect, Atrioventricular Block, Bronchospasm, Cardio-Respiratory Arrest, Congenital Pulmonary Valve Disorder, Dacryostenosis Acquired, Deafness, Developmental Delay, DiGeorge's Syndrome, Drug Exposure During Pregnancy, Eye Discharge, Fallot's Tetralogy, Gastrooesophageal Reflux Disease, Hypotonia, Microcephaly, Oxygen Saturation Decreased, Pallor, Patent Ductus Arteriosus, Pneumonia, Pulmonary Artery Dilatation, T-Lymphocyte Count Decreased, Underweight, Velo-Cardio-facial Syndrome
F 6319489 5333674 03/09/1999 05/24/2007 Paxil CN Craniosynostosis, Drug Exposure During Pregnancy
F 6319489 5534426 03/09/1999 12/05/2007 Paxil CN Depression Craniosynostosis, Drug Exposure During Pregnancy, Eyelid Ptosis, Heart Rate Irregular, Hypermetropia, Meconium Stain, Migraine, Strabismus, Tooth Disorder, Tooth Malformation
F 6319489 5620213 03/09/1999 02/08/2008 Paxil CN Depression Craniosynostosis, Drug Exposure During Pregnancy, Dyskinesia, Dysmorphism, Eyelid Ptosis, Heart Rate Irregular, Hypermetropia, Meconium Stain, Migraine, Muscle Tightness, Obstructive Airways Disorder, Pallor, Photophobia, Strabismus, Tooth Disorder, Tooth Malformation
F 6319489 5663065 03/09/1999 03/13/2008 Paxil CN Depression Cleft Palate, Craniosynostosis, Drug Exposure During Pregnancy, Dyskinesia, Dysmorphism, Eyelid Ptosis, Heart Rate Irregular, Hypermetropia, Meconium Stain, Migraine, Muscle Tightness, Obstructive Airways Disorder, Pallor, Photophobia, Strabismus, Tooth Disorder, Tooth Malformation
M 6319490 5333675 10/23/2001 05/24/2007 Paxil LW Atrial Septal Defect, Drug Exposure During Pregnancy, Mitral Valve Disease, Ventricular Septal Defect
M 6319490 5557527 10/23/2001 12/14/2007 Paxil MD Depression Anxiety, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Depression, Drug Exposure During Pregnancy, Electrocardiogram Pr Prolongation, Emotional Distress, Fear, Heart Sounds Abnormal, Keloid Scar, Mitral Valve Disease, Mitral Valve Incompetence, Patent Ductus Arteriosus, Right Ventricular Hypertrophy, Tricuspid Valve Incompetence, Ventricular Septal Defect
M 6319490 5597559 10/23/2001 01/21/2008 Paxil OT Depression Anxiety, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Depression, Drug Exposure During Pregnancy, Electrocardiogram Pr Prolongation, Emotional Distress, Fear, Heart Sounds Abnormal, Hypertrophic Scar, Keloid Scar, Mitral Valve Disease, Mitral Valve Incompetence, Patent Ductus Arteriosus, Pectus Carinatum, Respiratory Distress, Right Ventricular Hypertrophy, Sepsis, Tricuspid Valve Incompetence, Ventricular Septal Defect
M 6319490 5624657 10/23/2001 02/13/2008 Paxil OT Depression Anxiety, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Depression, Drug Exposure During Pregnancy, Electrocardiogram Pr Prolongation, Emotional Distress, Fear, Heart Sounds Abnormal, Hypertrophic Scar, Keloid Scar, Mitral Valve Disease, Mitral Valve Incompetence, Patent Ductus Arteriosus, Pectus Carinatum, Respiratory Distress, Right Ventricular Hypertrophy, Sepsis, Tricuspid Valve Incompetence, Ventricular Septal Defect
M 6319490 5653388 10/23/2001 03/06/2008 Paxil OT Depression Anxiety, Atrial Septal Defect, Bundle Branch Block Right, Cardiac Murmur, Cardiomegaly, Depression, Drug Exposure During Pregnancy, Electrocardiogram Pr Prolongation, Emotional Distress, Fear, Heart Sounds Abnormal, Hypertrophic Scar, Keloid Scar, Mitral Valve Disease, Mitral Valve Incompetence, Patent Ductus Arteriosus, Pectus Carinatum, Respiratory Distress, Right Ventricular Hypertrophy, Sepsis, Tricuspid Valve Incompetence, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6319491 5333676 02/06/2005 05/24/2007 Paxil CN Atrial Septal Defect, Congenital Pulmonary Valve Disorder, Drug Exposure During Pregnancy, Pulmonary Artery Dilatation, Pulmonary Valve Stenosis, Pulmonary Valve Stenosis Congenital
M 6319491 5557528 02/06/2005 12/14/2007 Paxil CN Depression Atrial Septal Defect, Bronchiolitis, Cardiac Murmur, Congenital Heart Valve Disorder, Congenital Pulmonary Valve Disorder, Drug Exposure During Pregnancy, Dysmorphism, Dyspnoea, Head Circumference Abnormal, Heart Disease Congenital, Hypertension, Hypertonia, Noonan Syndrome, Patent Ductus Arteriosus, Pulmonary Artery Dilatation, Pulmonary Valve Stenosis, Pulmonary Valve Stenosis Congenital, Respiratory Disorder, Respiratory Tract Congestion, Strabismus, Tachypnoea, Ventricular Hypertrophy, Wheezing
M 6319491 5594767 02/06/2005 01/17/2008 Paxil CN Depression Atrial Septal Defect, Bronchiolitis, Cardiac Murmur, Congenital Heart Valve Disorder, Congenital Pulmonary Valve Disorder, Drug Exposure During Pregnancy, Dysmorphism, Dyspnoea, Head Circumference Abnormal, Heart Disease Congenital, Hypertension, Hypertonia, Noonan Syndrome, Patent Ductus Arteriosus, Pulmonary Artery Dilatation, Pulmonary Valve Stenosis, Pulmonary Valve Stenosis Congenital, Respiratory Disorder, Respiratory Tract Congestion, Strabismus, Tachypnoea, Ventricular Hypertrophy, Wheezing
M 6319491 5597560 02/06/2005 01/21/2008 Paxil CN Depression Atrial Septal Defect, Bronchiolitis, Cardiac Murmur, Congenital Heart Valve Disorder, Congenital Pulmonary Valve Disorder, Drug Exposure During Pregnancy, Dysmorphism, Dyspnoea, Head Circumference Abnormal, Heart Disease Congenital, Hypertension, Hypertonia, Noonan Syndrome, Patent Ductus Arteriosus, Pulmonary Artery Dilatation, Pulmonary Valve Stenosis, Pulmonary Valve Stenosis Congenital, Respiratory Disorder, Respiratory Tract Congestion, Strabismus, Tachypnoea, Ventricular Hypertrophy, Wheezing
M 6319491 5626195 02/06/2005 02/14/2008 Paxil CN Depression Atrial Septal Defect, Bronchiolitis, Cardiac Murmur, Congenital Heart Valve Disorder, Congenital Pulmonary Valve Disorder, Drug Exposure During Pregnancy, Dysmorphism, Dyspnoea, Head Circumference Abnormal, Heart Disease Congenital, Hypertension, Hypertonia, Noonan Syndrome, Patent Ductus Arteriosus, Pulmonary Artery Dilatation, Pulmonary Valve Stenosis, Pulmonary Valve Stenosis Congenital, Respiratory Disorder, Respiratory Tract Congestion, Strabismus, Tachypnoea, Ventricular Hypertrophy, Wheezing
F 6319494 5333679 05/24/2007 Paxil CN Drug Use for Unknown Indication Abnormal Behaviour, Agitation, Asperger's Disorder, Asthenia, Autism, Cardiac Disorder, Crying, Depression, Drug Exposure During Pregnancy, Learning Disorder, Movement Disorder, Panic Attack
F 6319495 5333680 05/24/2007 Paxil CN Drug Use for Unknown Indication Cardiac Disorder, Cerebrovascular Accident, Drug Exposure During Pregnancy, Premature Baby, Respiratory Arrest, Speech Disorder Developmental
6323490 5340172 06/30/2005 05/31/2007 Paxil LW Congenital Anomaly, Drug Exposure During Pregnancy, Ventricular Septal Defect
F 6323490 5533230 06/03/2005 12/04/2007 Paxil CR LW Anxiety Congenital Anomaly, Convulsion, Developmental Delay, Drug Exposure During Pregnancy, Dyspnoea, Ventricular Septal Defect
F 6323490 5547207 06/03/2005 12/11/2007 Paxil CR PH Anxiety Congenital Anomaly, Convulsion, Developmental Delay, Drug Exposure During Pregnancy, Dyspnoea, Foetal Distress Syndrome, Foetal Heart Rate Deceleration, Haematocrit Decreased, Hypotonia, Meconium In Amniotic Fluid, Muscular Weakness, Pallor, Respiratory Distress, Speech Disorder Developmental, Ventricular Septal Defect
F 6323490 5624659 06/03/2005 02/13/2008 Paxil CR PH Anxiety Congenital Anomaly, Convulsion, Developmental Delay, Drug Exposure During Pregnancy, Dyspnoea, Foetal Distress Syndrome, Foetal Heart Rate Deceleration, Haematocrit Decreased, Hypotonia, Meconium In Amniotic Fluid, Muscular Weakness, Pallor, Respiratory Distress, Speech Disorder Developmental, Ventricular Septal Defect
F 6323490 5629639 06/03/2005 02/18/2008 Paxil CR PH Anxiety Anoxia, Anuria, Atrial Septal Defect, Cardiac Murmur, Convulsion, Developmental Delay, Drug Exposure During Pregnancy, Dyspnoea, Foetal Distress Syndrome, Foetal Heart Rate Deceleration, Generalised Oedema, Haematocrit Decreased, Hypotonia, Meconium In Amniotic Fluid, Muscular Weakness, Neonatal Asphyxia, Pallor, Pneumothorax, Respiratory Distress, Sepsis, Speech Disorder Developmental, Ventricular Septal Defect
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
M 6324502 5342156 07/11/2003 06/01/2007 Paxil CR CN Depression Cleft Lip, Cleft Palate, Drug Exposure During Pregnancy
F 6325593 5344102 05/25/2007 06/04/2007 Paxil MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Asphyxia, Tachypnoea, Tremor
F 6325593 5358913 05/25/2007 06/15/2007 Paxil MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Asphyxia, Tachypnoea, Tremor
F 6325593 5367059 05/25/2007 06/22/2007 Paxil MD Drug Use for Unknown Indication Bradycardia, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Asphyxia, Premature Baby, Tachypnoea, Tremor
M 6325594 5344103 05/25/2007 06/04/2007 Paxil MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Asphyxia, Tachypnoea, Tremor
M 6325594 5358914 05/25/2007 06/15/2007 Paxil MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Asphyxia, Tachypnoea, Tremor
M 6325594 5367060 05/25/2007 06/22/2007 Paxil MD Drug Use for Unknown Indication Agitation, Anxiety, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Asphyxia, Tachypnoea, Tremor