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.
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 4029187 | 4279756 | 01/23/2004 | Zoloft | MD | Anxiety, Depression | Maternal Drugs Affecting Foetus, Talipes | ||||||||
| F | 4029187 | 4439802 | 08/31/2004 | Zoloft | MD | Anxiety, Depression | Drug Exposure During Pregnancy, Talipes | |||||||
| M | 4072673 | 4274585 | 01/15/2004 | Lustral | Ill-Defined Disorder | Cleft Palate, Maternal Drugs Affecting Foetus | ||||||||
| M | 4079383 | 4279593 | 01/01/2003 | 01/23/2004 | Zoloft | Depression | Developmental Delay, Maternal Drugs Affecting Foetus, Premature Baby | |||||||
| M | 4079383 | 4320442 | 01/01/2003 | 03/17/2004 | Zoloft | Depression | Developmental Delay, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus, Premature Baby | |||||||
| 4091275 | 4290905 | 02/09/2004 | Sertraline | Depression | Cleft Palate, Maternal Drugs Affecting Foetus | |||||||||
| 4091288 | 4290304 | 02/09/2004 | Zoloft | PH | Ill-Defined Disorder | Craniosynostosis, Maternal Drugs Affecting Foetus, Neonatal Disorder, Sedation | ||||||||
| M | 4096798 | 4299537 | 01/22/2004 | 02/17/2004 | 01/24/2004 | Sertraline | MD | Depression | Complications of Maternal Exposure To Therapeutic Drugs, Congenital Diaphragmatic Anomaly, Death Neonatal, Maternal Drugs Affecting Foetus | |||||
| F | 4104019 | 4309452 | 03/01/2003 | 03/01/2004 | Zoloft | CN | Anxiety | Abortion Spontaneous, Anxiety, Complications of Maternal Exposure To Therapeutic Drugs, Insomnia, Maternal Drugs Affecting Foetus | ||||||
| 4115647 | 4323764 | 03/23/2004 | Sertraline | PH | Ill-Defined Disorder | Congenital Pulmonary Hypertension, Maternal Drugs Affecting Foetus | ||||||||
| M | 4116429 | 4325035 | 06/10/2001 | 03/26/2004 | Zoloft | CN | Depression | Abnormal Behaviour, Convulsion, Developmental Coordination Disorder, Drug Withdrawal Syndrome, Failure To Thrive, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Hypersensitivity, Respiratory Disorder, Sleep Disorder, Speech Disorder Developmental | ||||||
| F | 4132230 | 4343822 | 04/19/2004 | Zoloft | MD | Ill-Defined Disorder | Complications of Maternal Exposure To Therapeutic Drugs, Intra-Uterine Death, Maternal Drugs Affecting Foetus | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 4141045 | 4357105 | 05/07/2004 | Zoloft | CN | Ill-Defined Disorder | Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Maternal Drugs Affecting Foetus | |||||||
| F | 4146108 | 4362205 | 05/17/2004 | Zoloft | Depression | Abdominal Pain Upper, Abortion Spontaneous, Anorexia, Complications of Maternal Exposure To Therapeutic Drugs, Diarrhoea, Insomnia, Maternal Drugs Affecting Foetus, Tremor | ||||||||
| F | 4149822 | 4366950 | 05/24/2004 | Zoloft | MD | Depression | Abnormal Labour, Caesarean Section, Drug Exposure During Pregnancy | |||||||
| F | 4152267 | 4369731 | 01/01/2001 | 05/28/2004 | Zoloft | Depression | Blood Pressure Decreased, Bruxism, Cardiac Failure Congestive, Cardiomyopathy, Drug Exposure During Pregnancy, Tooth Injury, Treatment Noncompliance | |||||||
| F | 4160344 | 4381536 | 06/16/2004 | Zoloft | MD | Anxiety | Apgar Score Low, Blood PH Decreased, Congenital Nystagmus, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder, Oxygen Saturation Decreased, Premature Baby, Respiration Abnormal, Sleep Study Abnormal | |||||||
| M | 4164173 | 4386979 | 06/23/2004 | Sertraline | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Hypertonia Neonatal, Hypopnoea, Neonatal Disorder, Neonatal Respiratory Acidosis, Premature Baby | |||||||
| M | 4164173 | 4681058 | 06/01/2005 | Sertraline | MD | Drug Exposure During Pregnancy, Drug Toxicity, Drug Withdrawal Syndrome, Encephalopathy Neonatal, Hypertonia Neonatal, Neonatal Respiratory Acidosis, Neonatal Respiratory Distress Syndrome, Poisoning, Premature Baby | ||||||||
| F | 4169345 | 4394826 | 07/07/2004 | Zoloft | PH | Depression | Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Depression, Vomiting | |||||||
| 4171854 | 4396018 | 06/25/2004 | 07/08/2004 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure Via Breast Milk, Hypotonia | |||||||
| F | 4173942 | 4398380 | 03/10/2004 | 07/12/2004 | Zoloft | CN | Ill-Defined Disorder | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Eye Movement Disorder, Neonatal Disorder | ||||||
| F | 4173942 | 4432758 | 08/20/2004 | Zoloft | Ill-Defined Disorder | Congenital Nystagmus, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Eye Movement Disorder, Neonatal Disorder | ||||||||
| M | 4173949 | 4398702 | 07/12/2004 | Sertraline | MD | Ill-Defined Disorder | 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 | 4173949 | 4424117 | 08/09/2004 | Sertraline | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Talipes | |||||||
| M | 4181059 | 4408247 | 07/22/2004 | Sertraline | MD | Depression | Double Outlet Right Ventricle, Drug Exposure During Pregnancy | |||||||
| 4190892 | 4420032 | 01/01/2004 | 08/04/2004 | Zoloft | MD | Ill-Defined Disorder | Congenital Absence of Cranial Vault, Maternal Drugs Affecting Foetus | |||||||
| 4190892 | 4433757 | 01/01/2004 | 08/25/2004 | Zoloft | MD | Depression | Abortion Induced, Anencephaly, Congenital Anomaly, Drug Exposure During Pregnancy | |||||||
| 4192193 | 4423383 | 08/06/2004 | Zoloft | MD | Stress Symptoms | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypersensitivity, Hypoglycaemia Neonatal, Neonatal Apnoeic Attack, Neonatal Disorder, Unresponsive To Pain Stimuli | ||||||||
| 4194581 | 4415350 | 06/30/2004 | Zoloft | Ill-Defined Disorder | Drug Withdrawal Syndrome Neonatal | |||||||||
| 4199961 | 4432602 | 08/20/2004 | Zoloft | PH | Ill-Defined Disorder | Drug Exposure During Pregnancy, Foetal Heart Rate Decreased | ||||||||
| 4199961 | 4462199 | 09/24/2004 | Zoloft | PH | Ill-Defined Disorder | Drug Exposure During Pregnancy, Foetal Heart Rate Decreased | ||||||||
| 4206205 | 4438718 | 08/30/2004 | Zoloft | MD | Ill-Defined Disorder | Death Neonatal, Drug Exposure During Pregnancy | ||||||||
| 4206205 | 4467352 | 10/04/2004 | Zoloft | MD | Ill-Defined Disorder | Death Neonatal, Drug Exposure During Pregnancy, Foetal Disorder, Renal Disorder | ||||||||
| M | 4215277 | 4451661 | 12/24/2003 | 09/15/2004 | Lustral | MD | Depression Suicidal | Drug Withdrawal Syndrome, Hypotonia, Maternal Drugs Affecting Foetus, Restlessness, Shock, Tremor Neonatal | ||||||
| F | 4219244 | 4456694 | 09/21/2004 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Stillbirth | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 4221482 | 4457742 | 09/22/2004 | Sertraline | PH | Ill-Defined Disorder | Drug Exposure During Pregnancy, Foetal Growth Retardation, Oligohydramnios | |||||||
| M | 5665142 | 4467035 | 10/04/2004 | Zoloft | Mental Disorder | Anger, Autism, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea, Feeling Abnormal, Growth Retardation, Hypersensitivity, Mental Retardation Severity Unspecified, Mentally Late Developer, Movement Disorder, Nasopharyngitis, Neonatal Disorder | ||||||||
| M | 5691385 | 4515499 | 11/26/2004 | Zoloft | OT | Depression | Breech Presentation, Caesarean Section, Congenital Macrocephaly, Drug Exposure During Pregnancy | |||||||
| M | 5691385 | 4551622 | 01/11/2005 | Zoloft | OT | Depression | Breech Presentation, Caesarean Section, Chromosome Abnormality, Congenital Anomaly, Drug Exposure During Pregnancy, Macrocephaly | |||||||
| 5691595 | 4517000 | 11/30/2004 | Zoloft | MD | Ill-Defined Disorder | Caesarean Section, Drug Exposure During Pregnancy, Stillbirth | ||||||||
| F | 5703047 | 4530585 | 01/01/2004 | 12/16/2004 | Lustral | OT | Depression | Convulsion, Drug Exposure Via Breast Milk, Epilepsy | ||||||
| F | 5708736 | 4539759 | 12/22/2004 | Zoloft | OT | Ill-Defined Disorder | Drug Exposure During Pregnancy, Premature Labour, Vaginal Haemorrhage | |||||||
| F | 5708809 | 4539805 | 12/22/2004 | Zoloft | OT | Ill-Defined Disorder | Bed Rest, Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy, Premature Baby, Vaginal Haemorrhage | |||||||
| 5730126 | 4565038 | 01/26/2005 | Sertraline | OT | Depression | Abortion Induced, Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome | ||||||||
| M | 5741859 | 4576819 | 01/01/2004 | 02/07/2005 | Zoloft | Blood Bilirubin Increased, Caesarean Section, Coombs Direct Test Positive, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Flatulence, Large for Dates Baby, Transfusion Reaction | ||||||||
| M | 5741859 | 4596856 | 01/01/2004 | 02/28/2005 | Zoloft | MD | Ill-Defined Disorder | Amniotic Fluid Volume Increased, Blood Bilirubin Increased, Blood Pressure Increased, Caesarean Section, Coombs Test Positive, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Flatulence, Pre-Eclampsia, Premature Rupture of Membranes, Transfusion Reaction, Weight Decreased | ||||||
| F | 5743853 | 4579166 | 08/30/2002 | 02/08/2005 | Zoloft | OT | Depression | Drug Exposure During Pregnancy, Premature Labour | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 5748451 | 4586492 | 02/14/2005 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Foetal Heart Rate, Pulmonary Artery Atresia, Transposition of the Great Vessels, Univentricular Heart | ||||||||
| M | 5748451 | 4775029 | 09/20/2005 | Zoloft | MD | Ill-Defined Disorder | Abortion Induced, Congenital Pulmonary Valve Atresia, Drug Exposure During Pregnancy, Heart Disease Congenital, Pulmonary Artery Atresia, Transposition of the Great Vessels, Univentricular Heart, Ventricular Hypoplasia | |||||||
| F | 5757417 | 4598861 | 01/01/2004 | 03/01/2005 | Zoloft | MD | Depression | Abortion Induced, Caudal Regression Syndrome, Drug Exposure During Pregnancy | ||||||
| 5757417 | 4651028 | 01/01/2004 | 04/29/2005 | Zoloft | MD | Abortion Induced, Caudal Regression Syndrome, Drug Exposure During Pregnancy | ||||||||
| 5764329 | 4607006 | 03/10/2005 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Dyspnoea, Haematocrit Decreased, Neonatal Disorder, Snoring | ||||||||
| M | 5764329 | 4665299 | 05/17/2005 | Zoloft | MD | Drug Exposure During Pregnancy, Haematocrit Decreased, Neonatal Disorder, Respiratory Disorder Neonatal, Snoring | ||||||||
| 5769351 | 4618147 | 03/22/2005 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Limb Reduction Defect | ||||||||
| 5769351 | 4672914 | 03/08/2005 | 05/23/2005 | Zoloft | MD | Congenital Hand Malformation, Drug Exposure During Pregnancy | ||||||||
| 5773767 | 4627281 | 01/01/2004 | 03/31/2005 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Heart Disease Congenital | |||||||
| 5783410 | 4640448 | 04/19/2005 | Zoloft | MD | Congenital Anomaly, Drug Exposure During Pregnancy | |||||||||
| F | 5808187 | 4672764 | 05/23/2005 | Sertraline | MD | Agitation Neonatal, Blood Pressure Increased, Drug Exposure During Pregnancy, Feeling Jittery, Hypoglycaemia, Inappropriate Antidiuretic Hormone Secretion, Jaundice Neonatal, Large for Dates Baby, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Opisthotonus, Premature Baby, Serotonin Syndrome | ||||||||
| M | 5808310 | 4672755 | 01/01/2004 | 05/23/2005 | 12/12/2004 | Zoloft | MD | Coarctation of the Aorta, Drug Exposure During Pregnancy, Shock, 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 | 5812212 | 4678867 | 02/08/2003 | 05/31/2005 | Zoloft | MD | Abdominal Pain, Autism Spectrum Disorder, Caesarean Section, Drug Exposure During Pregnancy, Neonatal Disorder, Small for Dates Baby | |||||||
| F | 5812267 | 4678849 | 05/31/2005 | Zoloft | MD | Caesarean Section, Drug Exposure During Pregnancy, Infertility, Laboratory Test Interference, Metrorrhagia | ||||||||
| M | 5817786 | 4681897 | 06/02/2005 | Sertraline | PH | Ankyloglossia Congenital, Drug Exposure During Pregnancy | ||||||||
| M | 5821030 | 4686440 | 06/06/2005 | Zoloft | MD | Drug Exposure During Pregnancy, Talipes | ||||||||
| F | 5829949 | 4698499 | 06/22/2005 | Zoloft | CN | Abortion Spontaneous, Agitation, Bipolar Disorder, Caesarean Section, Depression, Drug Exposure During Pregnancy, Feeling Abnormal, Hallucination (Auditory), Hyperphagia, Hypersomnia, Intentional Self-Injury, Laceration, Mood Swings, Premature Labour, Psychomotor Hyperactivity, Suicidal Ideation, Suicide Attempt, Weight Decreased, Weight Increased | ||||||||
| F | 5837336 | 4713165 | 07/01/2005 | Zoloft | Anxiety, Depression | Affective Disorder, Anxiety, Drug Exposure During Pregnancy, Drug Ineffective, Haematoma, Haemorrhage, Insomnia, Panic Attack, Weight Increased | ||||||||
| 5837384 | 4713143 | 07/01/2005 | Zoloft | PH | Ill-Defined Disorder | Blood Glucose Abnormal, Drug Exposure During Pregnancy | ||||||||
| M | 5847805 | 4720539 | 05/01/2002 | 07/19/2005 | Zoloft | Ill-Defined Disorder | Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy | |||||||
| F | 5875780 | 4759815 | 09/30/2005 | 08/31/2005 | Zoloft | CN | Depression, Obsessive-Compulsive Disorder | Anger, Divorced, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hearing Impaired, Hot Flush, Lethargy, Nightmare, Overweight, Paraesthesia, Visual Disturbance | ||||||
| 5889761 | 4779487 | 09/23/2005 | Zoloft | Ill-Defined Disorder | Congenital Anomaly, Drug Exposure During Pregnancy | |||||||||
| M | 5890907 | 4854906 | 05/19/2003 | 12/13/2005 | Zoloft | MD | Ill-Defined Disorder | Apgar Score Low, Body Temperature Increased, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Respiratory Disorder Neonatal | ||||||
| M | 5890907 | 4855574 | 05/19/2003 | 12/14/2005 | Zoloft | MD | Ill-Defined Disorder | Apgar Score Low, Body Temperature Increased, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea, Respiratory Disorder Neonatal, Unevaluable Event | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 5898138 | 4788078 | 10/03/2005 | Zoloft | OT | Anxiety Disorder | Drug Exposure During Pregnancy, Fallot's Tetralogy | |||||||
| F | 5898138 | 4796751 | 10/07/2005 | Zoloft | OT | Anxiety Disorder | Drug Exposure During Pregnancy, Fallot's Tetralogy | |||||||
| M | 5906784 | 4801462 | 09/01/2005 | 10/11/2005 | Zoloft | PH | Ill-Defined Disorder | Caesarean Section, Drug Exposure During Pregnancy, Inappropriate Antidiuretic Hormone Secretion, Irritability, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Transient Tachypnoea of the Newborn, Urine Output Decreased | ||||||
| M | 5906784 | 4835875 | 09/01/2005 | 11/18/2005 | Zoloft | PH | Ill-Defined Disorder | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Inappropriate Antidiuretic Hormone Secretion, Irritability, Neonatal Respiratory Distress Syndrome, Transient Tachypnoea of the Newborn, Urine Output Decreased | ||||||
| 5923839 | 4823689 | 11/07/2005 | Sertraline | OT | Ill-Defined Disorder | Abortion Induced, Brain Malformation, Congenital Anomaly, Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy | ||||||||
| F | 5939541 | 4845459 | 11/25/2005 | Lustral | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Ectopic Pregnancy | |||||||
| F | 5939541 | 4847636 | 12/05/2005 | Sertraline | MD | Ill-Defined Disorder | Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy | |||||||
| F | 5939541 | 4871702 | 12/30/2005 | Lustral | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy, Treatment Noncompliance | |||||||
| F | 5940968 | 4846166 | 12/01/2005 | Sertraline | MD | Obsessive-Compulsive Disorder | Abortion Spontaneous, Congenital Anomaly, Drug Exposure During Pregnancy | |||||||
| 5940978 | 4846213 | 12/01/2005 | Sertraline | MD | Ill-Defined Disorder | Abortion, Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||
| 5940978 | 4911957 | 09/01/2005 | 02/13/2006 | Sertraline | MD | Ill-Defined Disorder | Abortion Spontaneous, Congenital Anomaly, Drug Exposure During Pregnancy | |||||||
| F | 5953854 | 4866747 | 01/01/2005 | 12/21/2005 | Zoloft | MD | Ill-Defined Disorder | Caesarean Section, Drug Exposure During Pregnancy, Premature Baby, Small for Dates 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 | 5954808 | 4866630 | 01/01/2005 | 12/22/2005 | Zoloft | MD | Ill-Defined Disorder | Caesarean Section, Drug Exposure During Pregnancy, Hellp Syndrome, Pre-Eclampsia, Premature Baby, Small for Dates Baby | ||||||
| F | 5954808 | 4903425 | 01/01/2005 | 02/03/2006 | Zoloft | MD | Ill-Defined Disorder | Caesarean Section, Drug Exposure During Pregnancy, Hellp Syndrome, Pre-Eclampsia, Premature Baby, Small for Dates Baby | ||||||
| F | 5961056 | 4874852 | 01/04/2006 | Sertraline | OT | Coarctation of the Aorta, Drug Exposure During Pregnancy | ||||||||
| F | 5962022 | 5195424 | 01/01/2000 | 12/29/2006 | Zoloft | CN | Depression | Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Crying, Decreased Appetite, Depression, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain In Extremity, Phobia, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Suicide Attempt, Tachycardia, Tremor, Vaginal Infection, Weight Decreased | ||||||
| F | 5962022 | 5226451 | 01/01/2000 | 02/01/2007 | Zoloft | CN | Depression | Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Breast Pain, Crying, Decreased Appetite, Depression, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain In Extremity, Phobia, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Suicide Attempt, Tachycardia, Tremor, Vaginal Infection, Weight Decreased | ||||||
| F | 5962022 | 5237992 | 01/01/2000 | 02/14/2007 | Zoloft | CN | Depression | Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Breast Pain, Confusional State, Crying, Decreased Appetite, Depression, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain In Extremity, Phobia, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased | ||||||
| F | 5962022 | 5267677 | 01/01/1999 | 03/16/2007 | Zoloft | CN | Depression | Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Breast Pain, Confusional State, Crying, Decreased Appetite, Depression, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased | ||||||
| F | 5962022 | 5279491 | 01/01/1999 | 03/28/2007 | Zoloft | CN | Depression | Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased | ||||||
| F | 5962022 | 5289846 | 01/01/1999 | 04/06/2007 | Zoloft | CN | Depression | Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased | ||||||
| F | 5962022 | 5352908 | 01/01/1999 | 06/11/2007 | Zoloft | CN | Depression | Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Constipation, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Premenstrual Syndrome, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased | ||||||
| F | 5962022 | 5398991 | 01/01/1999 | 07/27/2007 | Zoloft | CN | Depression | Abdominal Pain, Abortion, Agitation, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Constipation, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Premenstrual Syndrome, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased | ||||||
| F | 5962022 | 5406203 | 01/01/1999 | 08/06/2007 | Zoloft | CN | Depression | Abdominal Pain, Abortion, Agitation, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Constipation, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Premenstrual Syndrome, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, 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 | ||||
| F | 5962022 | 5411492 | 01/01/1999 | 08/10/2007 | Zoloft | CN | Depression | Abdominal Pain, Abortion, Agitation, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Blood Prolactin Increased, Breast Pain, Confusional State, Constipation, Crying, Decreased Appetite, Depression, Dizziness, Drug Ineffective, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Formication, Galactorrhoea, Grip Strength Decreased, Haemorrhage, Headache, Hunger, Hypersensitivity, Hypoaesthesia, Hypothyroidism, Influenza Like Illness, Insomnia, Irritability, Menstrual Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Pain, Pain In Extremity, Phobia, Premenstrual Syndrome, Rhinitis, Seborrhoeic Dermatitis, Shock, Sinusitis, Skin Lesion, Somnolence, Stress, Suicide Attempt, Tachycardia, Tendonitis, Tremor, Vaginal Infection, Weight Decreased, Weight Increased | ||||||
| 5976331 | 4893368 | 01/24/2006 | Sertraline | OT | Ill-Defined Disorder | Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy | ||||||||
| 5976331 | 4915701 | 02/13/2006 | Sertraline | OT | Ill-Defined Disorder | Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy | ||||||||
| 5976463 | 4895571 | 01/25/2006 | Sertraline | OT | Ill-Defined Disorder | Congenital Anomaly, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy | ||||||||
| 5976463 | 4915699 | 02/13/2006 | Sertraline | OT | Ill-Defined Disorder | Congenital Anomaly, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy | ||||||||
| F | 5980471 | 4905986 | 05/01/1997 | 02/06/2006 | Zoloft | Depression, Obsessive-Compulsive Disorder | Abortion Induced, Abortion Spontaneous, Aggression, Arthritis, Bronchitis, Burning Sensation, Caesarean Section, Drug Exposure During Pregnancy, Drug Intolerance, Economic Problem, Ectopic Pregnancy, Ectopic Pregnancy Termination, Inflammation, Irritable Bowel Syndrome, Laceration, Movement Disorder, Multiple Allergies, Pneumonia, Postpartum Depression, Skin Burning Sensation | |||||||
| F | 5982314 | 4898724 | 05/01/1996 | 01/31/2006 | Zoloft | Depression | Drug Exposure During Pregnancy, Jaundice Neonatal, Neonatal Aspiration, Neonatal Hypoxia | |||||||
| F | 5982428 | 4898726 | 01/31/2006 | Zoloft | Depression | Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Premature Baby | ||||||||
| 5982430 | 4898727 | 05/01/2002 | 01/31/2006 | 06/01/2002 | Zoloft | Depression | Abortion Spontaneous, Drug Exposure Before Pregnancy, Foetal Heart Rate Abnormal | |||||||
| M | 5982437 | 4898728 | 01/01/2003 | 01/31/2006 | Zoloft | Depression | Birth Trauma, Caesarean Section, Contusion, Drug Exposure During Pregnancy, Foetal Heart Rate Decreased, Head Injury, Jaundice Neonatal, Psychomotor Hyperactivity | |||||||
| 5985812 | 4901363 | 02/02/2006 | Zoloft | OT | Ill-Defined Disorder | Drug Exposure During Pregnancy, Heart Disease Congenital | ||||||||
| 5985812 | 4931342 | 02/28/2006 | Zoloft | OT | Ill-Defined Disorder | Congenital Pulmonary Hypertension, Drug Exposure During Pregnancy, Transposition of the Great Vessels | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 5987973 | 4903719 | 04/13/2005 | 02/02/2006 | Zoloft | MD | Depression | Congenital Foot Malformation, Drug Exposure During Pregnancy | ||||||
| F | 5988300 | 4910686 | 02/08/2006 | Zoloft | MD | Depression | Amniotic Fluid Volume Decreased, Death Neonatal, Drug Exposure During Pregnancy, Pulmonary Hypoplasia, Renal Aplasia | |||||||
| 5993043 | 4914129 | 02/10/2006 | Zoloft | MD | Ill-Defined Disorder | Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||
| M | 5997647 | 4919120 | 10/01/2004 | 02/16/2006 | Zoloft | OT | Ill-Defined Disorder | Abdominal Pain, Anorectal Disorder, Ano-Rectal Stenosis, Cardiac Murmur, Dacryostenosis Congenital, Drug Exposure During Pregnancy, Foetal Disorder, Gastrooesophageal Reflux Disease, Liver Disorder, Neonatal Disorder, Renal Disorder, Ultrasound Antenatal Screen Abnormal, Vomiting Neonatal | ||||||
| M | 5999313 | 4923537 | 02/21/2006 | Zoloft | Ill-Defined Disorder | Drug Exposure During Pregnancy, Premature Baby | ||||||||
| 5999314 | 4923538 | 02/21/2006 | Zoloft | Ill-Defined Disorder | Drug Exposure During Pregnancy, Drug Ineffective, Premature Baby | |||||||||
| F | 5999316 | 4923539 | 02/21/2006 | Zoloft | Ill-Defined Disorder | Blindness, Cerebral Haemorrhage Neonatal, Cerebral Palsy, Cerebrovascular Accident, Choking, Congenital Anomaly, Congenital Central Nervous System Anomaly, Convulsion Neonatal, Developmental Delay, Drug Exposure During Pregnancy, Foetal Disorder, Neonatal Disorder, Paralysis, Premature Baby | ||||||||
| F | 5999322 | 4923543 | 02/21/2006 | Zoloft | Depression | Abortion Spontaneous, Benign Hydatidiform Mole, Drug Exposure During Pregnancy, Drug Ineffective | ||||||||
| 6004426 | 4931423 | 02/28/2006 | Sertraline | Ill-Defined Disorder | Drug Exposure During Pregnancy, Neonatal Respiratory Failure, Persistent Foetal Circulation | |||||||||
| 6004426 | 4935162 | 03/02/2006 | Sertraline | Ill-Defined Disorder | Drug Exposure During Pregnancy, Neonatal Respiratory Failure | |||||||||
| M | 6012204 | 4947470 | 03/13/2006 | Zoloft | Ill-Defined Disorder | Caesarean Section, Drug Dependence, Drug Exposure During Pregnancy, Hypothermia Neonatal, Neonatal Complications of Substance Abuse, Neonatal Disorder, Obstetric Procedure Complication, Placenta Praevia, Premature Baby, Small for Dates Baby, Weight Decrease Neonatal | ||||||||
| F | 6017790 | 4952799 | 03/20/2006 | Zoloft | Ill-Defined Disorder | Back Pain, Cardiac Failure Congestive, Condition Aggravated, Crying, Drug Exposure During Pregnancy, Emotional Disorder, False Labour, Fluid Overload, Fluid Retention | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6017866 | 4952879 | 03/20/2006 | Zoloft | Ill-Defined Disorder | Adenotonsillectomy, Clavicle Fracture, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypersensitivity, Mood Altered, Nasopharyngitis, Neonatal Disorder | ||||||||
| 6025552 | 4963873 | 03/30/2006 | Zoloft | OT | Ill-Defined Disorder | Drug Exposure During Pregnancy, Muscle Rigidity | ||||||||
| 6028166 | 4968167 | 04/05/2006 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Muscle Spasms, Myoclonus, Premature Baby | ||||||||
| F | 6030534 | 4971758 | 04/06/2006 | Sertraline | Ill-Defined Disorder | Drug Toxicity, Drug Withdrawal Syndrome Neonatal, Electroencephalogram Abnormal, Feeling Jittery, Irritability, Myoclonus, Opisthotonus, Tardive Dyskinesia | ||||||||
| F | 6030534 | 4978204 | 04/17/2006 | Sertraline | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Electroencephalogram Abnormal | |||||||
| M | 6032090 | 4973917 | 04/10/2006 | Sertraline | MD | Depression | Abdominal Pain, Adenocarcinoma, Back Pain, Cognitive Disorder, Coma, Compression Fracture, Drug Interaction, Drug Level Increased, Drug Toxicity, Drug Withdrawal Syndrome, Failure To Thrive, Gastrooesophageal Cancer, Hallucination, Laboratory Test Interference, Malnutrition, Myoclonus, Osteoporosis, Pain, Respiratory Depression, Schizophrenia (Paranoid Type) | |||||||
| 6032118 | 4974597 | 12/01/2004 | 04/10/2006 | Zoloft | Ill-Defined Disorder | Drug Exposure During Pregnancy, Premature Baby | ||||||||
| M | 6032118 | 4978933 | 01/01/2005 | 04/17/2006 | Zoloft | Ill-Defined Disorder | Depression, Drug Exposure During Pregnancy, Eclampsia, Gestational Diabetes, Pre-Eclampsia, Premature Labour | |||||||
| 6036577 | 4980890 | 04/18/2006 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Speech Disorder Developmental | ||||||||
| 6036577 | 5021750 | 06/05/2006 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Speech Disorder Developmental | ||||||||
| F | 6050909 | 5000500 | 05/01/2006 | Zoloft | PH | Ill-Defined Disorder | Drug Exposure During Pregnancy, High Risk Pregnancy | |||||||
| 6052121 | 5003389 | 05/11/2006 | Sertraline | OT | Depression | Drug Exposure During Pregnancy, Trisomy 13 | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6059314 | 5012114 | 05/24/2006 | Zoloft | Bipolar I Disorder | Crying, Depressed Mood, Drug Exposure During Pregnancy, Feeling Abnormal, Irritability, Post-Traumatic Stress Disorder, Uterine Leiomyoma | ||||||||
| 6062602 | 5018180 | 02/16/2006 | 05/30/2006 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Trisomy 21 | |||||||
| F | 6068239 | 5025988 | 06/12/2006 | Zoloft | CN | Drug Exposure During Pregnancy | ||||||||
| F | 6071696 | 5027296 | 06/08/2006 | Zoloft | MD | Affective Disorder, Bulimia Nervosa | Appendicectomy, Drug Exposure During Pregnancy | |||||||
| F | 6074637 | 5030049 | 06/14/2006 | Zoloft | MD | Anxiety Disorder, Major Depression | Caesarean Section, Drug Dependence, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Respiratory Distress Syndrome, Pericardial Effusion | |||||||
| F | 6074728 | 5030328 | 06/15/2006 | Zoloft | MD | Ill-Defined Disorder | Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Disorder, Neonatal Respiratory Distress Syndrome, Pericardial Effusion | |||||||
| F | 6082098 | 5046659 | 06/26/2006 | 07/07/2006 | Zoloft | CN | Obsessive-Compulsive Disorder | Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Tremor Neonatal | ||||||
| F | 6094262 | 5060200 | 01/01/2006 | 07/20/2006 | Zoloft | Depression | Anxiety, Drug Exposure During Pregnancy, Heart Rate Increased, Mental Disorder | |||||||
| F | 6094262 | 5087111 | 01/01/2006 | 08/21/2006 | Zoloft | Depression | Anxiety, Drug Exposure During Pregnancy, Heart Rate Increased, Mental Disorder | |||||||
| 6097216 | 5062325 | 07/21/2006 | Zoloft | OT | Depression | Alpha 1 Foetoprotein Amniotic Fluid Increased, Drug Exposure During Pregnancy, Foetal Disorder, Microcephaly, Restlessness, Schizophrenia (Paranoid Type), Spinal Deformity | ||||||||
| 6097216 | 5170577 | 12/05/2006 | Zoloft | OT | Depression | Alpha 1 Foetoprotein Increased, Drug Exposure During Pregnancy, Microcephaly, Spine Malformation | ||||||||
| F | 6119624 | 5087490 | 08/21/2006 | Zoloft | Drug Use for Unknown Indication | Depersonalisation, Drug Exposure Before Pregnancy | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6127279 | 5096582 | 08/30/2006 | Zoloft | MD | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Polydactyly | ||||||||
| M | 6127279 | 5109788 | 09/15/2006 | Zoloft | MD | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Polydactyly | |||||||
| F | 6130557 | 5100783 | 09/06/2006 | Zoloft | Drug Use for Unknown Indication | Caesarean Section, Drug Exposure During Pregnancy, Placenta Praevia | ||||||||
| F | 6130557 | 5100902 | 09/06/2006 | Zoloft | Drug Use for Unknown Indication | Caesarean Section, Drug Exposure During Pregnancy, Placenta Praevia, Treatment Noncompliance, Wrong Technique In Drug Usage Process | ||||||||
| M | 6132419 | 5102426 | 08/01/2006 | 09/07/2006 | Sertraline | MD | Drug Use for Unknown Indication | Circulatory Failure Neonatal, Cyanosis Neonatal, Drug Exposure During Pregnancy, Neonatal Disorder, Pulmonary Hypertension | ||||||
| M | 6138425 | 5107885 | 05/15/2006 | 09/15/2006 | 05/15/2006 | Zoloft | Pelvic Pain | Death Neonatal, Drug Exposure During Pregnancy, Premature Baby | ||||||
| M | 6141471 | 5115370 | 09/22/2006 | Sertraline | MD | Depression | Apgar Score Low, Drug Exposure During Pregnancy, Transient Tachypnoea of the Newborn | |||||||
| F | 6141550 | 5115354 | 09/22/2006 | Zoloft | MD | Abortion Spontaneous, Anxiety, Drug Exposure During Pregnancy | ||||||||
| F | 6150456 | 5126474 | 10/10/2006 | Zoloft | Postpartum Depression | Drug Exposure During Pregnancy | ||||||||
| F | 6151008 | 5127963 | 10/10/2006 | Sertraline | OT | Depression | Anaemia, Drug Exposure During Pregnancy, Haemorrhage, Labour Complication, Premature Baby | |||||||
| 6161631 | 5143671 | 11/03/2006 | Sertraline | Drug Exposure During Pregnancy, Fallot's Tetralogy | ||||||||||
| M | 6161913 | 5135563 | 09/25/2005 | 10/20/2006 | Zoloft | OT | Depression | Drug Exposure During Pregnancy, Pulmonary Hypoplasia, Renal Aplasia | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 6161913 | 5149947 | 09/25/2005 | 11/08/2006 | 09/25/2005 | Zoloft | OT | Depression | Anal Atresia, Congenital Great Vessel Anomaly, Death Neonatal, Drug Exposure During Pregnancy, Pulmonary Hypoplasia, Renal Aplasia, Ventricular Septal Defect | |||||
| M | 6163094 | 5136637 | 10/23/2006 | Zoloft | Developmental Delay, Drug Exposure Via Breast Milk | |||||||||
| 6177271 | 5154390 | 11/14/2006 | Sertraline | OT | Drug Exposure During Pregnancy, Heart Disease Congenital | |||||||||
| 6177271 | 5154428 | 11/14/2006 | Sertraline | OT | Congenital Anomaly, Drug Exposure During Pregnancy, Multiple Cardiac Defects | |||||||||
| 6177454 | 5154422 | 11/14/2006 | Sertraline | OT | Drug Exposure During Pregnancy, Fallot's Tetralogy, Heart Disease Congenital | |||||||||
| 6177454 | 5155632 | 11/14/2006 | Sertraline | OT | Drug Exposure During Pregnancy, Fallot's Tetralogy | |||||||||
| F | 6180068 | 5157791 | 11/16/2006 | Zoloft | Depression | Drug Exposure During Pregnancy, Uterine Contractions Abnormal | ||||||||
| M | 6188507 | 5167682 | 04/01/2006 | 12/01/2006 | Zoloft | Depression, Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder | Cleft Lip, Congenital Anomaly, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy | |||||||
| F | 6205538 | 5179886 | 12/11/2006 | 11/19/2006 | Sertraline | MD | Depression | Apgar Score Low, Brain Damage, Caesarean Section, Drug Exposure During Pregnancy, Encephalitis, Neonatal Asphyxia, Neonatal Disorder, Placenta Praevia | ||||||
| F | 6205863 | 5195390 | 01/17/2004 | 12/29/2006 | 01/17/2004 | Zoloft | CN | Panic Attack | Drug Exposure During Pregnancy, Stillbirth | |||||
| F | 6205867 | 5195394 | 12/19/2006 | 12/29/2006 | Zoloft | CN | Panic Attack | Dizziness, Drug Exposure During Pregnancy, Fall, Nausea | ||||||
| F | 6207748 | 5189934 | 12/15/2006 | Zoloft | Depression, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, 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 | ||||
| F | 6216358 | 5209695 | 01/01/2006 | 01/16/2007 | Lustral | MD | Depression | Drug Exposure During Pregnancy, Postpartum Depression, Weight Increased | ||||||
| F | 6216358 | 5213797 | 01/01/2006 | 01/19/2007 | Lustral | MD | Depression | Postpartum Depression, Weight Increased | ||||||
| M | 6219032 | 5213781 | 03/01/2005 | 01/19/2007 | Zoloft | OT | Dysthymic Disorder | Dental Caries, Drug Exposure During Pregnancy, Enamel Anomaly, Tooth Disorder | ||||||
| M | 6220152 | 5215038 | 10/03/2006 | 01/22/2007 | Zoloft | MD | Choking, Cyanosis, Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Jaundice Neonatal, Retching, Vomiting | |||||||
| M | 6237091 | 5224759 | 01/23/2007 | 01/29/2007 | Zoloft | MD | Depression | Congenital Anomaly, Drug Exposure During Pregnancy, Polydactyly, Syndactyly | ||||||
| 6238139 | 5227169 | 01/30/2007 | Sertraline | Drug Use for Unknown Indication | Cleft Palate, Drug Exposure During Pregnancy | |||||||||
| 6241009 | 5230775 | 02/02/2007 | Sertraline | Cleft Lip and Palate, Drug Exposure During Pregnancy | ||||||||||
| F | 6244433 | 5245702 | 10/01/2006 | 02/23/2007 | Zoloft | CN | Anxiety | Abortion Spontaneous | ||||||
| 6255718 | 5258146 | 03/07/2007 | Sertraline | Cleft Lip, Cleft Palate | ||||||||||
| 6255733 | 5258153 | 03/07/2007 | Sertraline | Cleft Lip, Cleft Palate, Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||||
| F | 6258271 | 5261149 | 11/03/2006 | 03/09/2007 | Zoloft | MD | Affective Disorder | Arrested Labour | ||||||
| F | 6259897 | 5254889 | 02/19/2007 | 03/02/2007 | Zoloft | MD | Anxiety, Depression | Cerebral Cyst, Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Polydactyly, Tremor | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6260279 | 5264063 | 03/13/2007 | Sertraline | Cleft Lip, Cleft Palate, Drug Exposure During Pregnancy | ||||||||||
| F | 6262816 | 5266609 | 12/01/2006 | 03/15/2007 | Zoloft | MD | Depression | Coarctation of the Aorta, Drug Exposure During Pregnancy, Neonatal Aspiration, Pyloric Stenosis | ||||||
| F | 6262825 | 5266618 | 11/01/2006 | 03/15/2007 | Zoloft | MD | Depression | Drug Exposure During Pregnancy, Urinary Tract Infection | ||||||
| 6274536 | 5271848 | 01/01/2006 | 03/16/2007 | Sertraline | Cleft Lip and Palate, Drug Exposure During Pregnancy | |||||||||
| F | 6293093 | 5303494 | 01/01/2006 | 04/20/2007 | 01/21/2007 | Zoloft | MD | Drug Exposure During Pregnancy, Muscle Twitching, Sudden Death | ||||||
| F | 6293184 | 5303574 | 04/10/2006 | 04/20/2007 | Zoloft | OT | Drug Exposure During Pregnancy, Foetal Distress Syndrome, Placental Disorder | |||||||
| F | 6293184 | 5344472 | 04/10/2006 | 06/04/2007 | Zoloft | OT | Drug Exposure During Pregnancy, Foetal Distress Syndrome, Placental Disorder | |||||||
| F | 6293184 | 5588039 | 04/10/2006 | 01/11/2008 | Zoloft | OT | Caesarean Section, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Placental Disorder, Premature Labour, Retroplacental Haematoma | |||||||
| F | 6293365 | 5303756 | 04/20/2007 | Zoloft | OT | Ill-Defined Disorder | Drug Exposure During Pregnancy, Pulmonary Hypertension, Transposition of the Great Vessels | |||||||
| F | 6293365 | 5310838 | 04/28/2007 | Zoloft | OT | Ill-Defined Disorder | Developmental Delay, Drug Exposure During Pregnancy, Pulmonary Hypertension, Transposition of the Great Vessels | |||||||
| M | 6299193 | 5310832 | 01/01/2006 | 04/28/2007 | Zoloft | MD | Congenital Absence of Bile Ducts, Drug Exposure During Pregnancy, Nausea | |||||||
| 6300964 | 5312758 | 04/30/2007 | Sertraline | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Laryngomalacia, Muscle Spasms, Tremor | ||||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6300965 | 5312759 | 04/30/2007 | Sertraline | Choking, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Hypersensitivity, Hypervigilance, Irritability | ||||||||||
| F | 6301858 | 5313961 | 05/01/2007 | 11/19/2006 | Lustral | CN | Depression | Congenital Brain Damage, Drug Exposure During Pregnancy, Encephalitis, Neonatal Asphyxia | ||||||
| 6303154 | 5315333 | 05/02/2007 | Sertraline | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Laryngomalacia, Muscle Spasms, Tremor | ||||||||||
| M | 6303165 | 5315341 | 05/02/2007 | Sertraline | Drug Exposure During Pregnancy, Neurodevelopmental Disorder | |||||||||
| M | 6305289 | 5317339 | 05/04/2007 | Sertraline | Drug Exposure During Pregnancy, Myotonia | |||||||||
| 6305291 | 5317341 | 05/04/2007 | Sertraline | Choking, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Hypersensitivity, Hypervigilance, Irritability | ||||||||||
| 6305972 | 5318342 | 05/07/2007 | Zoloft | CN | Drug Exposure During Pregnancy, Foetal Growth Retardation | |||||||||
| M | 6312796 | 5319707 | 05/03/2007 | Sertraline | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Limb Malformation | ||||||||
| M | 6317201 | 5324409 | 05/09/2007 | Sertraline | OT | Drug Exposure During Pregnancy, Limb Malformation | ||||||||
| M | 6317568 | 5320884 | 05/04/2007 | Sertraline | Drug Exposure During Pregnancy, Limb Malformation | |||||||||
| M | 6319832 | 5334065 | 04/17/2007 | 05/24/2007 | Sertraline | OT | Convulsion, Drug Exposure During Pregnancy, Dyskinesia, Grunting, Hypervigilance, Tachypnoea, Tremor | |||||||
| M | 6320026 | 5328229 | 05/14/2007 | Sertraline | Drug Exposure During Pregnancy | 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 | 6324792 | 5342734 | 06/01/2007 | Sertraline | OT | Depression | Cardiac Septal Defect, Congenital Anomaly, Drug Exposure During Pregnancy | |||||||
| M | 6324897 | 5342833 | 01/01/2003 | 06/01/2007 | 05/05/2005 | Zoloft | LW | Cardiac Disorder, Congenital Anomaly, Drug Exposure During Pregnancy | ||||||
| M | 6325376 | 5332175 | 05/21/2007 | Sertraline | Drug Exposure During Pregnancy | Congenital Neurological Disorder, Drug Exposure During Pregnancy, Maternal Alcohol Use, Maternal Use of Illicit Drugs | ||||||||
| F | 6329220 | 5339386 | 04/16/2007 | 05/25/2007 | Sertraline | Depression | Caesarean Section, Drug Exposure During Pregnancy, Polyhydramnios | |||||||
| M | 6331022 | 5341715 | 04/17/2007 | 05/30/2007 | Sertraline | MD | Depression | Bradycardia Neonatal, Caesarean Section, Convulsion Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Grunting, Hypervigilance, Neonatal Disorder, Neonatal Tachypnoea, Oxygen Saturation Decreased, Tremor Neonatal | ||||||
| F | 6332545 | 5356258 | 06/12/2007 | Zoloft | CN | Blood Pressure Decreased, Stillbirth, Syncope Vasovagal | ||||||||
| F | 6333045 | 5346658 | 06/04/2007 | Sertraline | Depression | Cardiac Septal Defect, Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy | ||||||||
| F | 6336104 | 5353028 | 06/06/2007 | Sertraline | Drug Exposure During Pregnancy | Cardiac Septal Defect, Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||
| F | 6336243 | 5352182 | 06/06/2007 | Sertraline | OT | Depression | Cardiac Septal Defect, Congenital Anomaly | |||||||
| F | 6336456 | 5346738 | 06/04/2007 | Sertraline | Drug Exposure During Pregnancy | Cardiac Septal Defect, Drug Exposure During Pregnancy, Multiple Congenital Abnormalities | ||||||||
| M | 6343509 | 5339402 | 04/17/2007 | 05/25/2007 | Sertraline | Depression | Caesarean Section, Convulsion Neonatal, Drug Exposure During Pregnancy, Grunting, Hypervigilance, Movement Disorder, Neonatal Disorder, Neonatal Tachypnoea, Polyhydramnios, Tremor Neonatal | |||||||
| F | 6344681 | 5357409 | 06/12/2007 | Sertraline | Depression | Cardiac Septal Defect, 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 | ||||
| M | 6347579 | 5376413 | 01/01/2006 | 07/02/2007 | Zoloft | MD | Apnoea, Convulsion, Cyanosis, Drug Exposure During Pregnancy, Hypertonia, Intercostal Retraction, Muscle Twitching, Nystagmus | |||||||
| 6348681 | 5377702 | 07/03/2007 | Sertraline | Neural Tube Defect | ||||||||||
| M | 6349437 | 5372618 | 06/26/2007 | Sertraline | OT | Caesarean Section, Drug Exposure During Pregnancy, Premature Baby | ||||||||
| 6355011 | 5384787 | 07/11/2007 | Sertraline | Craniosynostosis, Drug Exposure During Pregnancy | ||||||||||
| 6355015 | 5384798 | 07/11/2007 | Sertraline | Neural Tube Defect | ||||||||||
| M | 6357039 | 5386931 | 01/01/2006 | 07/13/2007 | Zoloft | OT | Depression | Convulsion, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea | ||||||
| M | 6357096 | 5386977 | 07/13/2007 | Zoloft | PH | Blood Magnesium Decreased, Drug Exposure During Pregnancy, Hypocalcaemia, Pulmonary Hypertension | ||||||||
| M | 6357096 | 5443782 | 01/01/2007 | 09/05/2007 | Zoloft | MD | Depression | Blood Magnesium Decreased, Drug Exposure During Pregnancy, Hypocalcaemia, Pulmonary Hypertension | ||||||
| F | 6362551 | 5390511 | 07/12/2007 | Sertraline | Depression | Cardiac Septal Defect, Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||
| 6367112 | 5397099 | 07/25/2007 | Sertraline | OT | Depression | Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||
| F | 6370470 | 5400697 | 07/30/2007 | Sertraline | MD | Depression | Congenital Anomaly, Heart Disease Congenital, Transmission of Drug Via Semen | |||||||
| 6370787 | 5400171 | 07/25/2007 | Sertraline | Congenital Anomaly, Drug Exposure During Pregnancy, Lower Limb Deformity, Upper Limb Deformity | ||||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6370875 | 5400120 | 07/25/2007 | Sertraline | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Limb Deformity, Multiple Congenital Abnormalities | |||||||||
| 6375913 | 5402760 | 07/27/2007 | Sertraline | Depression | Congenital Anomaly, Congenital Hand Malformation, Drug Exposure During Pregnancy | |||||||||
| 6376522 | 5400142 | 07/25/2007 | Sertraline | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Limb Malformation | |||||||||
| F | 6376976 | 5381404 | 06/29/2007 | Zoloft | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Respiratory Distress | ||||||||
| 6377487 | 5381376 | 06/29/2007 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Respiratory Disorder Neonatal | ||||||||
| 6381107 | 5407052 | 08/03/2007 | Sertraline | Depression | Congenital Anomaly, Drug Exposure During Pregnancy | |||||||||
| 6385727 | 5413302 | 08/10/2007 | Sertraline | OT | Depression | Congenital Anomaly, Drug Exposure During Pregnancy, Limb Reduction Defect | ||||||||
| 6391885 | 5426494 | 01/01/2007 | 08/27/2007 | Daxid | MD | Drug Exposure During Pregnancy, Movement Disorder, Neonatal Disorder | ||||||||
| 6394045 | 5430070 | 08/29/2007 | 06/04/2007 | Zoloft | MD | Congenital Tricuspid Valve Atresia, Drug Exposure During Pregnancy | ||||||||
| 6394045 | 5505564 | 11/02/2007 | 06/04/2007 | Zoloft | MD | Congenital Tricuspid Valve Atresia, Drug Exposure During Pregnancy | ||||||||
| 6407696 | 5445166 | 06/26/2006 | 09/06/2007 | Zoloft | OT | Depression | Alpha 1 Foetoprotein Increased, Drug Exposure During Pregnancy, Microcephaly, Spine Malformation | |||||||
| M | 6407698 | 5445169 | 01/01/2005 | 09/06/2007 | Zoloft | MD | Drug Exposure During Pregnancy, Hypertension, Respiratory Rate Increased | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6408795 | 5446586 | 01/01/2006 | 09/07/2007 | Zoloft | CN | Postpartum Depression | Cyanosis, Drug Exposure During Pregnancy, Neonatal Disorder, Vocal Cord Paresis | ||||||
| F | 6408795 | 5530942 | 01/01/2006 | 11/30/2007 | Zoloft | MD | Postpartum Depression | Cyanosis, Drug Exposure During Pregnancy, Feeding Disorder of Infancy or Early Childhood, Neonatal Disorder, Pyloric Stenosis, Thermal Burn, Vocal Cord Paresis | ||||||
| 6408858 | 5446699 | 01/01/2005 | 09/07/2007 | Zoloft | MD | Cyanosis, Death, Drug Exposure During Pregnancy | ||||||||
| F | 6413211 | 5451802 | 09/13/2007 | Zoloft | MD | Depression | Postpartum Depression | |||||||
| M | 6438640 | 5477089 | 10/03/2007 | Zoloft | Anxiety, Depression, Obsessive-Compulsive Disorder, Trichotillomania | Cardiac Disorder, Cardiac Perforation, Cardiac Valve Disease, Drug Exposure During Pregnancy, Heart Valve Incompetence | ||||||||
| 6438680 | 5469259 | 09/24/2007 | Sertraline | OT | Drug Exposure During Pregnancy | Cleft Lip and Palate, Drug Exposure During Pregnancy | ||||||||
| M | 6438993 | 5470535 | 09/27/2007 | 05/05/2005 | Zoloft | Adrenal Disorder | Aortic Stenosis, Atrial Septal Defect, Bicuspid Aortic Valve, Cleft Palate, Congenital Arterial Malformation, Congenital Pulmonary Hypertension, DiGeorge's Syndrome, Drug Exposure During Pregnancy, Gastrointestinal Disorder, Persistent Foetal Circulation, Ventricular Septal Defect | |||||||
| F | 6441549 | 5484589 | 10/12/2007 | Sertraline | MD | Depression | Stillbirth, Vaginal Haemorrhage | |||||||
| F | 6441549 | 5511748 | 04/14/2007 | 11/09/2007 | Sertraline | MD | Depression | Antiphospholipid Syndrome, Stillbirth, Vaginal Haemorrhage | ||||||
| 6460634 | 5508048 | 04/14/2007 | 11/06/2007 | Sertraline | OT | Depression | Stillbirth, Vaginal Haemorrhage | |||||||
| F | 6469170 | 5518608 | 01/01/1999 | 11/15/2007 | Zoloft | CN | Abortion Spontaneous | |||||||
| M | 6470958 | 5520759 | 11/19/2007 | Zoloft | LW | Aortic Stenosis, Cardiac Septal Defect, Collapse of Lung, Drug Exposure During Pregnancy, Dysphagia, Persistent Foetal Circulation | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 6470959 | 5520761 | 11/19/2007 | Zoloft | LW | Atrial Septal Defect, Drug Exposure During Pregnancy | ||||||||
| F | 6470960 | 5520762 | 11/19/2007 | Zoloft | LW | Depression | Drug Exposure During Pregnancy, Takayasu's Arteritis | |||||||
| M | 6470963 | 5520765 | 01/01/1999 | 11/19/2007 | Zoloft | LW | Drug Exposure During Pregnancy, Hypoplastic Right Heart Syndrome | |||||||
| F | 6470968 | 5520770 | 03/01/2005 | 11/19/2007 | Zoloft | LW | Atrial Septal Defect, Cardiac Murmur, Drug Exposure During Pregnancy, Ventricular Septal Defect, Weight Gain Poor | |||||||
| M | 6471531 | 5521439 | 11/19/2007 | Zoloft | LW | Arterial Disorder, Drug Exposure During Pregnancy | ||||||||
| F | 6471532 | 5521440 | 11/19/2007 | Zoloft | LW | Coarctation of the Aorta, Drug Exposure During Pregnancy, Ventricular Septal Defect | ||||||||
| 6471535 | 5521442 | 01/01/2001 | 11/19/2007 | Zoloft | LW | Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Persistent Foetal Circulation | ||||||||
| F | 6471536 | 5521443 | 11/19/2007 | Zoloft | LW | Depression | Aortic Valve Stenosis, Cardiac Failure, Drug Exposure During Pregnancy | |||||||
| M | 6471537 | 5521444 | 01/01/2000 | 11/19/2007 | Zoloft | LW | Depression | Complement Factor C4, Developmental Delay, Drug Exposure During Pregnancy, Pulmonary Valve Stenosis, Single Functional Kidney | ||||||
| M | 6472581 | 5522639 | 11/20/2007 | Zoloft | LW | Asthma, Developmental Delay, Drug Exposure During Pregnancy, Fallot's Tetralogy, Grand Mal Convulsion | ||||||||
| F | 6473253 | 5523619 | 01/01/2006 | 11/21/2007 | Zoloft | CN | Body Temperature Increased, Cyanosis, Discomfort, Drug Exposure During Pregnancy, Dysphagia, Dyspnoea, Hypertension, Hypoplastic Right Heart Syndrome, Influenza Like Illness, Irritability, Laryngeal Stenosis, Psychomotor Skills Impaired, Speech Disorder Developmental, Transposition of the Great Vessels, Univentricular Heart | |||||||
| F | 6473253 | 5526353 | 01/01/2006 | 11/27/2007 | Zoloft | CN | Body Temperature Increased, Cyanosis, Discomfort, Drug Exposure During Pregnancy, Dysphagia, Dyspnoea, Hypertension, Hypoplastic Right Heart Syndrome, Influenza Like Illness, Irritability, Laryngeal Stenosis, Psychomotor Skills Impaired, Speech Disorder Developmental, Transposition of the Great Vessels, Univentricular Heart | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6473563 | 5524143 | 11/21/2007 | Zoloft | LW | Drug Exposure During Pregnancy, Post-Traumatic Stress Disorder, Ventricular Septal Defect | ||||||||
| F | 6473566 | 5524146 | 11/21/2007 | Zoloft | LW | Anomalous Pulmonary Venous Connection, Drug Exposure During Pregnancy, Post Procedural Complication, Ventricular Septal Defect | ||||||||
| F | 6473568 | 5524149 | 11/21/2007 | Zoloft | LW | Aortic Stenosis, Developmental Delay, Drug Exposure During Pregnancy, Exomphalos | ||||||||
| F | 6473667 | 5524297 | 11/21/2007 | Zoloft | LW | Drug Exposure During Pregnancy, Ebstein's Anomaly | ||||||||
| M | 6473668 | 5524298 | 11/21/2007 | Zoloft | LW | Drug Exposure During Pregnancy, Transposition of the Great Vessels | ||||||||
| M | 6473669 | 5524299 | 11/21/2007 | Zoloft | LW | Drug Exposure During Pregnancy, Limb Reduction Defect | ||||||||
| M | 6473670 | 5524300 | 11/21/2007 | Zoloft | LW | Drug Exposure During Pregnancy, Heart Valve Incompetence, Transposition of the Great Vessels, Ventricular Septal Defect | ||||||||
| F | 6473672 | 5524302 | 01/01/2006 | 11/21/2007 | Zoloft | CN | Atrial Septal Defect, Drug Exposure During Pregnancy, Patent Ductus Arteriosus, Ventricular Septal Defect | |||||||
| F | 6473673 | 5524303 | 11/21/2007 | Zoloft | CN | Atrial Septal Defect, Drug Exposure During Pregnancy | ||||||||
| F | 6473675 | 5524305 | 01/01/2005 | 11/21/2007 | Zoloft | CN | Cardiac Failure, Coarctation of the Aorta, Developmental Delay, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Organ Failure, Vocal Cord Paralysis | |||||||
| M | 6473677 | 5524307 | 11/21/2007 | Zoloft | LW | Drug Exposure During Pregnancy, Dyspnoea, Fallot's Tetralogy, Laryngeal Stenosis | ||||||||
| F | 6496046 | 5551770 | 11/16/2007 | 12/12/2007 | Zoloft | PH | Abortion Spontaneous, Menorrhagia | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6518173 | 5579809 | 01/02/2008 | Zoloft | MD | Abortion Spontaneous | ||||||||
| F | 6518173 | 5599322 | 01/22/2008 | Zoloft | MD | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||||
| F | 6524930 | 5588595 | 01/11/2008 | Zoloft | CN | Depression | Abortion Induced, Intra-Uterine Death | |||||||
| F | 6526665 | 5590689 | 01/01/2005 | 01/14/2008 | Zoloft | CN | Schizoaffective Disorder | Abdominal Pain Upper, Cholecystectomy, Endometriosis, Joint Dislocation, Mania, Migraine, Ovarian Cyst, Pre-Eclampsia, Vomiting | ||||||
| M | 6533315 | 5600654 | 01/23/2008 | Zoloft | CN | Developmental Delay, Drug Exposure During Pregnancy | ||||||||
| M | 6533315 | 5628501 | 02/15/2008 | Zoloft | CN | Developmental Delay, Drug Exposure During Pregnancy | ||||||||
| M | 6533315 | 5639339 | 02/26/2008 | Zoloft | CN | Developmental Delay, Drug Exposure During Pregnancy | ||||||||
| M | 6533316 | 5600655 | 01/23/2008 | Zoloft | CN | Developmental Delay, Drug Exposure During Pregnancy | ||||||||
| M | 6533316 | 5628455 | 02/15/2008 | Zoloft | CN | Developmental Delay, Drug Exposure During Pregnancy | ||||||||
| M | 6533316 | 5639337 | 02/26/2008 | Zoloft | CN | Developmental Delay, Drug Exposure During Pregnancy | ||||||||
| F | 6533341 | 5600702 | 09/25/2007 | 01/23/2008 | Zoloft | OT | Bradycardia Neonatal, Drug Exposure During Pregnancy | |||||||
| 6536879 | 5605208 | 01/01/2006 | 01/28/2008 | Zoloft | PH | Apnoea, Drug Exposure During Pregnancy, Hypotonia, Oxygen Saturation Decreased, Vomiting | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6539702 | 5608828 | 03/17/2007 | 01/31/2008 | 03/17/2007 | Sertraline | MD | Panic Disorder | Death Neonatal, Hypotonia Neonatal | ||||||
| F | 6549012 | 5620961 | 08/02/2007 | 02/08/2008 | Zoloft | MD | Depression | Drug Exposure During Pregnancy, Haemangioma, Patent Ductus Arteriosus | ||||||
| F | 6554631 | 5635365 | 08/01/2006 | 02/22/2008 | Sertraline | MD | Depression | Diabetes Insipidus, Drug Exposure During Pregnancy, Jaundice Neonatal | ||||||
| F | 6602391 | 5689501 | 02/15/2008 | 03/31/2008 | Serlain | MD | Anxiety Disorder | Abortion Spontaneous | ||||||
| 0 | Days | M | 3967126 | 4382202 | 06/15/2004 | Zoloft | MD | Depression | Blood Glucose Decreased, Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Hyperreflexia, Neonatal Disorder, Neonatal Tachypnoea, Reflexes Abnormal | |||||
| 0 | Days | M | 4145779 | 4360946 | 05/17/2004 | Zoloft | MD | Depression | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hyperventilation, Laryngomalacia, Neonatal Disorder, Tardive Dyskinesia | |||||
| 0 | Days | F | 5829568 | 4698486 | 01/01/2003 | 06/22/2005 | Zoloft | Caesarean Section, Drug Exposure During Pregnancy, Neonatal Aspiration, Premature Baby, Umbilical Cord Around Neck | ||||||
| M | 6470958 | 5786332 | 06/07/2006 | 06/24/2008 | Zoloft | CN | Postpartum Depression | Aortic Valve Stenosis, Arthritis, Blood Pressure Systolic Decreased, Bone Disorder, Cardiac Septal Defect, Collapse of Lung, Congenital Heart Valve Disorder, Developmental Delay, Drug Exposure During Pregnancy, Dysphagia, Ear Infection, Eczema, Feeding Disorder of Infancy or Early Childhood, Hypothalamo-Pituitary Disorder, Lethargy, Patent Ductus Arteriosus, Persistent Foetal Circulation, Pneumonia, Respiratory Distress, Walking Disability | ||||||
| M | 6470959 | 5786339 | 03/29/2001 | 06/24/2008 | Zoloft | CN | Depression | Atrial Septal Defect, Developmental Delay, Drug Exposure During Pregnancy, Ear Infection, Ear Malformation, Failure To Thrive, Foetal Growth Retardation, Head Deformity, Hydronephrosis, Hypospadias, Respiratory Disorder, Talipes, Umbilical Cord Abnormality, Ventricular Septal Defect, Weight Gain Poor | ||||||
| F | 6470960 | 5782276 | 06/23/2008 | Zoloft | LW | Depression | Angiopathy, Drug Exposure During Pregnancy, Laryngeal Stenosis, Respiratory Distress, Takayasu's Arteritis, Underweight | |||||||
| F | 6470968 | 5786364 | 03/01/2005 | 06/24/2008 | Zoloft | CN | Anxiety | Atrial Septal Defect, Cardiac Murmur, Drug Exposure During Pregnancy, Ventricular Septal Defect, Weight Gain Poor | ||||||
| M | 6471531 | 5786334 | 04/24/2003 | 06/24/2008 | Zoloft | LW | Depression | Arterial Disorder, Dehydration, Drug Exposure During Pregnancy, Hypoxia, Neonatal Aspiration, Pneumonia Bacterial, Respiratory Distress, Vasoconstriction, Viral 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 | 6471532 | 5786341 | 04/01/2005 | 06/24/2008 | Zoloft | LW | Depression | Aortic Elongation, Bicuspid Aortic Valve, Coarctation of the Aorta, Drug Exposure During Pregnancy, Scar, Ventricular Septal Defect | ||||||
| M | 6471535 | 5786360 | 01/01/2001 | 06/24/2008 | Zoloft | LW | Depression | Asthma, Cognitive Disorder, Collapse of Lung, Developmental Delay, Drug Exposure During Pregnancy, Failure To Thrive, Feeding Disorder Neonatal, Food Allergy, Gastric Disorder, Neonatal Respiratory Distress Syndrome, Persistent Foetal Circulation, Tachycardia, Weight Decreased | ||||||
| F | 6471536 | 5786357 | 01/01/2004 | 06/24/2008 | Zoloft | LW | Depression | Aortic Valve Stenosis, Cardiac Failure, Cardiac Murmur, Cardiomegaly, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Pneumonia | ||||||
| M | 6471537 | 5786356 | 01/01/2000 | 06/24/2008 | Zoloft | LW | Depression | Arthropathy, Atrial Septal Defect, Cardiac Murmur, Complement Factor C4 Decreased, Cyanosis, Developmental Delay, Dizziness, Drug Exposure During Pregnancy, Dyspepsia, Ear Infection, Headache, Hypertension, Hypertrophy, Myoclonic Epilepsy, Palpitations, Pulmonary Valve Stenosis, Single Functional Kidney, Sleep Apnoea Syndrome, Syncope, Thalassaemia, Urinary Tract Infection | ||||||
| M | 6472581 | 5786359 | 06/24/2008 | Zoloft | LW | Asthma, Developmental Delay, Drug Exposure During Pregnancy, Fallot's Tetralogy, Grand Mal Convulsion, Pulmonary Artery Atresia, Respiratory Distress | ||||||||
| F | 6473253 | 5786333 | 01/01/2006 | 06/24/2008 | Zoloft | LW | Postpartum Depression | Aortic Disorder, Body Temperature Increased, Cyanosis, Discomfort, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Dysphagia, Dyspnoea, Hypertension, Hypoplastic Right Heart Syndrome, Influenza Like Illness, Irritability, Laryngeal Stenosis, Psychomotor Skills Impaired, Pulmonary Valve Stenosis, Speech Disorder Developmental, Transposition of the Great Vessels, Ventricular Septal Defect | ||||||
| F | 6473563 | 5786232 | 06/24/2008 | Zoloft | LW | Tension Headache | Drug Exposure During Pregnancy, Post-Traumatic Stress Disorder, Ventricular Septal Defect | |||||||
| F | 6473566 | 5786363 | 07/02/2005 | 06/24/2008 | Zoloft | LW | Postpartum Depression | Anomalous Pulmonary Venous Connection, Croup Infectious, Drug Exposure During Pregnancy, Ear Infection, Nasopharyngitis, Post Procedural Complication, Respiratory Tract Infection, Ventricular Septal Defect | ||||||
| F | 6473568 | 5786361 | 03/01/2006 | 06/24/2008 | Zoloft | LW | Depression | Aortic Stenosis, Developmental Delay, Drug Exposure During Pregnancy, Exomphalos, Lung Disorder, Mitral Valve Prolapse, Scar | ||||||
| M | 6473669 | 5782279 | 08/24/2000 | 06/23/2008 | Zoloft | LW | Depression | Drug Exposure During Pregnancy, Limb Reduction Defect, Scoliosis, Tooth Disorder, Torticollis | ||||||
| F | 6473673 | 5782281 | 09/15/1999 | 06/23/2008 | Zoloft | CN | Depression | Atrial Septal Defect, Dental Caries, Drug Exposure During Pregnancy, Ear Infection, Enamel Anomaly, Migraine | ||||||
| F | 6473675 | 5786436 | 01/01/2005 | 06/24/2008 | Zoloft | LW | Depression | Cardiac Failure, Cardiac Septal Defect, Coarctation of the Aorta, Developmental Delay, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Organ Failure, Vocal Cord Paralysis | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 6473677 | 5786337 | 12/02/2005 | 06/24/2008 | Zoloft | CN | Postpartum Depression | Caesarean Section, Cardiac Murmur, Deafness, Developmental Delay, Drug Exposure During Pregnancy, Dyspnoea, Fallot's Tetralogy, Gastrooesophageal Reflux Disease, Laryngeal Stenosis, Vocal Cord Disorder, Weight Gain Poor | ||||||
| F | 6549012 | 5710198 | 08/02/2007 | 04/18/2008 | Zoloft | MD | Depression | Drug Exposure During Pregnancy, Haemangioma, Patent Ductus Arteriosus | ||||||
| 6605627 | 5693977 | 04/03/2008 | Zoloft | MD | Congenital Anomaly, Drug Exposure During Pregnancy | |||||||||
| F | 6606594 | 5695131 | 03/10/2008 | 04/04/2008 | Zoloft | MD | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia, Neonatal Asphyxia, Tremor | |||||||
| F | 6606594 | 5705982 | 03/10/2008 | 04/15/2008 | Zoloft | MD | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia, Neonatal Asphyxia, Tremor | |||||||
| F | 6612937 | 5703087 | 04/11/2008 | Lustral | MD | Bipolar Disorder | Arrested Labour, Malaise, Prolonged Labour | |||||||
| F | 6613483 | 5697925 | 08/31/2006 | 04/04/2008 | Zoloft | Anxiety | Atrial Septal Defect, Drug Exposure During Pregnancy, Pulmonary Valve Stenosis | |||||||
| M | 6614556 | 5705033 | 01/01/2004 | 04/14/2008 | Zoloft | CN | Depression | Asthma, Drug Exposure During Pregnancy, Dyspnoea, Gastroenteritis Eosinophilic, Premature Baby | ||||||
| 6616405 | 5707654 | 04/16/2008 | 11/30/2004 | Zoloft | CN | Drug Exposure During Pregnancy, Foetal Distress Syndrome, Persistent Foetal Circulation, Umbilical Cord Around Neck | ||||||||
| M | 6624961 | 5718465 | 04/25/2008 | Zoloft | MD | Panic Disorder | Drug Exposure During Pregnancy, Hypospadias | |||||||
| F | 6625123 | 5718729 | 04/25/2008 | Zoloft | MD | Panic Disorder | Drug Exposure During Pregnancy, Urinary Tract Disorder | |||||||
| 6625128 | 5718734 | 04/25/2008 | Sertraline | PH | Convulsion, Drug Exposure During Pregnancy, Eye Rolling, Muscle Twitching, Small for Dates 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 | 6629360 | 5723522 | 04/30/2008 | Sertraline | OT | Depression | Abnormal Palmar/Plantar Creases, Ear Malformation, Foetal Damage, Head Deformity, Polyhydramnios | |||||||
| 6631056 | 5725887 | 05/02/2008 | Sertraline | OT | Depression | Abnormal Palmar/Plantar Creases, Ear Malformation, Foetal Damage, Head Deformity, Polyhydramnios | ||||||||
| M | 6634711 | 5730805 | 05/07/2008 | Sertraline | OT | Depression | Abnormal Palmar/Plantar Creases, Ear Malformation, Foetal Damage, Head Deformity, Polyhydramnios | |||||||
| 6635155 | 5731292 | 05/08/2008 | Sertraline | OT | Convulsion, Drug Exposure During Pregnancy, Eye Rolling, Muscle Twitching, Small for Dates Baby | |||||||||
| F | 6635833 | 5732130 | 08/28/2007 | 05/08/2008 | Sertraline | MD | Depression | Abortion Spontaneous | ||||||
| F | 6637437 | 5734030 | 01/01/2007 | 05/09/2008 | Lustral | MD | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||
| M | 6645185 | 5731283 | 05/05/2008 | Sertraline | Depression | Abnormal Palmar/Plantar Creases, Ear Malformation, Foetal Damage, Head Deformity, Maternal Drugs Affecting Foetus, Polyhydramnios | ||||||||
| M | 6645185 | 5736924 | 05/09/2008 | Sertraline | Depression | Abnormal Palmar/Plantar Creases, Ear Malformation, Foetal Malformation, Head Deformity, Maternal Drugs Affecting Foetus, Polyhydramnios | ||||||||
| M | 6645326 | 5731272 | 05/05/2008 | Sertraline | Abnormal Palmar/Plantar Creases, Caesarean Section, Drug Exposure During Pregnancy, Ear Malformation, Foetal Damage, Head Deformity, Maternal Drugs Affecting Foetus, Polyhydramnios, Unstable Foetal Lie | |||||||||
| M | 6646894 | 5732526 | 05/06/2008 | Sertraline | Drug Exposure During Pregnancy | Abnormal Palmar/Plantar Creases, Caesarean Section, Drug Exposure During Pregnancy, Ear Malformation, Foetal Damage, Head Deformity, Oblique Presentation, Polyhydramnios | ||||||||
| M | 6646894 | 5738012 | 05/09/2008 | Sertraline | Drug Exposure During Pregnancy | Abnormal Palmar/Plantar Creases, Caesarean Section, Drug Exposure During Pregnancy, Ear Malformation, Foetal Damage, Head Deformity, Maternal Drugs Affecting Foetus, Multiple Congenital Abnormalities, Oblique Presentation, Polyhydramnios | ||||||||
| 6647495 | 5744929 | 08/28/2007 | 05/21/2008 | Sertraline | OT | Anxiety | Abortion Spontaneous | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6652267 | 5752755 | 04/13/2007 | 05/29/2008 | Zoloft | OT | Anxiety | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||
| 6652465 | 5741427 | 05/14/2008 | Sertraline | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Partial Seizures, Small for Dates Baby | |||||||||
| 6653025 | 5742526 | 05/15/2008 | Sertraline | Drug Use for Unknown Indication | Convulsion Neonatal, Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Neonatal Disorder, Small for Dates Baby | |||||||||
| 6653025 | 5744912 | 05/16/2008 | Sertraline | Drug Use for Unknown Indication | Convulsion, Drug Exposure During Pregnancy, Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Small for Dates Baby | |||||||||
| 6653025 | 5744914 | 05/16/2008 | Sertraline | Drug Use for Unknown Indication | Convulsion, Drug Exposure During Pregnancy, Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Small for Dates Baby | |||||||||
| 6653035 | 5742552 | 05/15/2008 | Sertraline | OT | Convulsion Neonatal, Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Neonatal Disorder, Small for Dates Baby | |||||||||
| M | 6653992 | 5744041 | 05/16/2008 | Sertraline | OT | Depression | Abnormal Palmar/Plantar Creases, Caesarean Section, Ear Malformation, Head Deformity, Maternal Drugs Affecting Foetus, Polyhydramnios, Unstable Foetal Lie | |||||||
| 6654587 | 5743792 | 04/08/2008 | 05/16/2008 | Sertraline | Eye Rolling, Maternal Drugs Affecting Foetus, Muscle Twitching, Partial Seizures, Small for Dates Baby | |||||||||
| M | 6654856 | 5743810 | 07/01/2005 | 05/16/2008 | Sertraline | Depression | Abnormal Palmar/Plantar Creases, Caesarean Section, Congenital Anomaly, Ear Malformation, Head Deformity, Maternal Drugs Affecting Foetus, Polyhydramnios, Unstable Foetal Lie | |||||||
| F | 6662662 | 5766101 | 01/23/2007 | 06/11/2008 | Zoloft | MD | Depression | Drug Exposure During Pregnancy, Intra-Uterine Death | ||||||
| M | 6675623 | 5782394 | 06/23/2008 | Zoloft | LW | Depression | Cerebral Haemorrhage, Convulsion, Developmental Delay, Drug Exposure During Pregnancy, Kidney Enlargement, Persistent Foetal Circulation, Pneumonia | |||||||
| F | 6675777 | 5782565 | 09/06/2003 | 06/23/2008 | Zoloft | CN | Anxiety | Cardiac Murmur, Drug Exposure During Pregnancy, Supravalvular Aortic Stenosis | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6676049 | 5782590 | 01/01/1998 | 06/24/2008 | Zoloft | LW | Anxiety | Anal Atresia, Constipation, Crying, Drug Exposure During Pregnancy, Flatulence | ||||||
| F | 6679509 | 5786435 | 06/24/2008 | 06/17/1998 | Zoloft | LW | Depression | Congenital Diaphragmatic Hernia, Dextrocardia, Drug Exposure During Pregnancy, Respiratory Distress | ||||||
| M | 6679510 | 5786437 | 06/24/2008 | Zoloft | LW | Anxiety | Asplenia, Drug Exposure During Pregnancy, Heart Disease Congenital, Hypertension, Phaeochromocytoma, Pulmonary Artery Atresia, Transposition of the Great Vessels | |||||||
| F | 6679545 | 5786477 | 11/26/2006 | 06/24/2008 | Zoloft | LW | Congenital Pulmonary Valve Atresia, Drug Exposure During Pregnancy, Fallot's Tetralogy, Patent Ductus Arteriosus | |||||||
| F | 6679623 | 5786574 | 08/17/2005 | 06/24/2008 | Zoloft | LW | Depression | Abdominal Pain, Cleft Lip and Palate, Constipation, Craniosynostosis, Drug Exposure During Pregnancy, Ear Infection, Fine Motor Delay, Gastrooesophageal Reflux Disease, Mild Mental Retardation, Mixed Receptive-Expressive Language Disorder, Perinatal Brain Damage, Weight Gain Poor | ||||||
| M | 6679624 | 5786575 | 04/21/2007 | 06/24/2008 | Zoloft | LW | Panic Attack | Cardiac Murmur, Drug Exposure During Pregnancy, Patent Ductus Arteriosus, Pulmonary Valve Stenosis | ||||||
| F | 6679625 | 5786576 | 01/02/2002 | 06/24/2008 | Zoloft | LW | Depression | Atrial Septal Defect, Cyanosis, Drug Exposure During Pregnancy, Hypertension, Patent Ductus Arteriosus, Pleural Effusion, Pulmonary Valve Stenosis, Tricuspid Valve Incompetence, Ventricular Septal Defect, Wound Infection | ||||||
| M | 6679626 | 5786577 | 06/24/2008 | Zoloft | LW | Depression | Bradycardia Foetal, Cephalhaematoma, Craniosynostosis, Developmental Delay, Drug Exposure During Pregnancy, Head Deformity, Movement Disorder, Nervousness, Premature Baby, Respiratory Distress | |||||||
| M | 6679627 | 5786578 | 04/20/2004 | 06/24/2008 | Sertraline | LW | Depression | Drug Exposure During Pregnancy, Pulmonary Artery Atresia, Pulmonary Hypertension, Pulmonary Valve Stenosis, Tricuspid Valve Disease, Ventricular Septal Defect | ||||||
| M | 6679630 | 5786580 | 06/24/2008 | Zoloft | LW | Depression | Drug Exposure During Pregnancy, Fallot's Tetralogy, Lung Disorder | |||||||
| F | 6679631 | 5786581 | 01/07/2004 | 06/24/2008 | Zoloft | LW | Depression | Congenital Anomaly, Drug Exposure During Pregnancy, Renal Cyst, Renal Impairment | ||||||
| F | 6679632 | 5786582 | 06/24/2008 | Zoloft | CN | Aortic Disorder, Cerebellar Hypoplasia, Congenital Central Nervous System Anomaly, Congenital Pulmonary Hypertension, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Hypothalamo-Pituitary Disorder, Nervous System Disorder, Patent Ductus Arteriosus, Spine Malformation, 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 | 6679633 | 5786583 | 06/24/2008 | Zoloft | LW | Coarctation of the Aorta, Drug Exposure During Pregnancy, Mitral Valve Disease, Pulmonary Hypertension, Respiratory Distress | ||||||||
| F | 6679650 | 5786596 | 09/01/2006 | 06/24/2008 | Zoloft | LW | Generalised Anxiety Disorder | Atrial Septal Defect, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Jaundice, Lethargy, Pulmonary Valve Stenosis, Unresponsive To Stimuli | ||||||
| F | 6679651 | 5786597 | 06/24/2008 | Zoloft | LW | Panic Disorder | Atrial Septal Defect, Drug Exposure During Pregnancy, Patent Ductus Arteriosus, Pulmonary Hypertension, Ventricular Septal Defect | |||||||
| M | 6679652 | 5786598 | 01/01/2005 | 06/24/2008 | Zoloft | LW | Depression | Congenital Arterial Malformation, Drug Exposure During Pregnancy, Jaundice Neonatal, Pulmonary Valve Incompetence | ||||||
| F | 6679653 | 5786599 | 06/24/2008 | Zoloft | LW | Atrial Septal Defect, Coarctation of the Aorta, Drug Exposure During Pregnancy, Ventricular Septal Defect | ||||||||
| F | 6679655 | 5786601 | 03/31/2004 | 06/24/2008 | 04/16/2004 | Zoloft | LW | Depression | Aortic Valve Stenosis, Atrial Septal Defect, Atrioventricular Septal Defect, Cardiac Murmur, Drug Exposure During Pregnancy, Hepatic Congestion, Lung Disorder, Mitral Valve Hypoplasia, Multiple Congenital Abnormalities, Patent Ductus Arteriosus, Persistent Foetal Circulation, Renal Tubular Necrosis, Right Ventricular Hypertrophy | |||||
| M | 6679656 | 5786602 | 06/11/2006 | 06/24/2008 | Zoloft | CN | Anomaly of External Ear Congenital, Craniosynostosis, Drug Exposure During Pregnancy | |||||||
| M | 6679657 | 5786603 | 06/16/2006 | 06/24/2008 | Zoloft | LW | Aortic Valve Incompetence, Atrial Septal Defect, Auricular Swelling, Double Outlet Right Ventricle, Drug Exposure During Pregnancy, Heart Disease Congenital, Respiratory Distress, Transposition of the Great Vessels, Ventricular Septal Defect | |||||||
| M | 6679677 | 5786610 | 06/01/2007 | 06/24/2008 | Zoloft | LW | Premenstrual Syndrome | Collapse of Lung, Drug Exposure During Pregnancy, Ear Infection, Post Procedural Complication, Transposition of the Great Vessels | ||||||
| M | 6679678 | 5786611 | 06/16/2005 | 06/24/2008 | Zoloft | LW | Depression | Atrial Septal Defect, Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome, Mitral Valve Incompetence, Renal Impairment | ||||||
| F | 6679679 | 5786613 | 06/24/2008 | Zoloft | LW | Obsessive-Compulsive Disorder | Cardiac Valve Disease, Drug Exposure During Pregnancy, Lung Disorder, Persistent Foetal Circulation, Plasminogen Activator Inhibitor | |||||||
| M | 6679681 | 5786614 | 02/27/1998 | 06/24/2008 | Zoloft | CN | Abdominal Pain, Asthma, Attention Deficit/Hyperactivity Disorder, Drug Exposure During Pregnancy, Pulmonary Hypertension, Respiratory Disorder, Respiratory Tract Infection, Skin Discolouration | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 6679709 | 5786629 | 09/06/2006 | 06/24/2008 | Zoloft | LW | Postpartum Depression | Cardiac Arrest, Congenital Oesophageal Web, Drug Exposure During Pregnancy, Eczema, Fallot's Tetralogy, Gastrointestinal Malformation, Haematochezia, Hypokinesia, Jaundice, Otitis Media, Respiratory Tract Infection, Speech Disorder | ||||||
| F | 6686031 | 5794225 | 06/27/2008 | Zoloft | LW | Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||
| F | 6686039 | 5794234 | 06/27/2008 | Zoloft | LW | Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||
| 1 | Hours | M | 6360092 | 5386143 | 06/27/2007 | 07/11/2007 | Zoloft | MD | Depression | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeling Jittery, Hyperreflexia, Hypertonia, Hypoglycaemia Neonatal, Hypomagnesaemia, Irritability, Neonatal Disorder | ||||
| 14 | Hours | M | 6329239 | 5339441 | 01/01/2007 | 05/25/2007 | Sertraline | Bradycardia Neonatal, Caesarean Section, Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Grunting, Hypervigilance, Neonatal Disorder, Neonatal Tachypnoea, Oxygen Saturation Decreased, Posture Abnormal, Tremor Neonatal | ||||||
| 14 | Hours | M | 6330851 | 5341700 | 04/17/2007 | 05/30/2007 | Sertraline | Drug Exposure During Pregnancy | Caesarean Section, Convulsion Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Grunting, Hypervigilance, Neonatal Disorder, Neonatal Tachypnoea, Tremor Neonatal | |||||
| 14 | Hours | M | 6519681 | 5339441 | 05/25/2007 | Sertraline | OT | Bradycardia Neonatal, Caesarean Section, Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Grunting, Hypervigilance, Neonatal Disorder, Neonatal Tachypnoea, Oxygen Saturation Decreased, Posture Abnormal, Tremor Neonatal | ||||||
| 1 | Day | M | 4135868 | 4350168 | 03/14/2004 | 04/26/2004 | Zoloft | MD | Depression | Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus | ||||
| 1 | Day | M | 4164053 | 4386180 | 06/22/2004 | Zoloft | MD | Ill-Defined Disorder | Body Temperature Decreased, Bradycardia, Cerebral Haemorrhage Neonatal, Cerebral Ventricle Dilatation, Drug Exposure During Pregnancy, Heart Rate Increased, Indirect Infection Transmission, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby, Respiratory Rate Increased, Small for Dates Baby | |||||
| 1 | Day | M | 4164053 | 4517077 | 11/30/2004 | Zoloft | MD | Ill-Defined Disorder | Body Temperature Decreased, Bradycardia Neonatal, Cerebral Haemorrhage Neonatal, Cerebral Ventricle Dilatation, Cyanosis Neonatal, Drug Exposure During Pregnancy, Foetal Disorder, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby, Unwanted Pregnancy, Vertical Infection Transmission | |||||
| 1 | Day | F | 5820115 | 4686967 | 06/06/2005 | Zoloft | MD | Arrhythmia Neonatal, Blood Glucose Decreased, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Neonatal Tachycardia, Oxygen Saturation Decreased, Premature Baby, Supraventricular Tachycardia | ||||||
| 1 | Day | F | 5890877 | 4781137 | 11/22/2003 | 09/26/2005 | Zoloft | MD | Ill-Defined Disorder | Congenital Nose Malformation, Congenital Nystagmus, Developmental Coordination Disorder, Drug Exposure During Pregnancy, Eye Movement Disorder, Fallot's Tetralogy, Hypertelorism of Orbit, Neonatal Disorder, Skull Malformation, Strabismus Congenital, Vascular Anomaly | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 1 | Day | F | 5953854 | 4899301 | 10/17/2005 | 01/31/2006 | Zoloft | MD | Ill-Defined Disorder | Caesarean Section, Diarrhoea, Drug Exposure During Pregnancy, Premature Baby, Small for Dates Baby | ||||
| 1 | Day | F | 5981216 | 4899760 | 12/01/2005 | 01/31/2006 | 01/18/2006 | Zoloft | Ill-Defined Disorder | Drug Exposure During Pregnancy, Premature Baby, Respiratory Disorder Neonatal | ||||
| 1 | Day | F | 5981216 | 4983107 | 12/01/2005 | 04/20/2006 | 01/18/2006 | Zoloft | MD | Ill-Defined Disorder | Apgar Score Low, Chorioamnionitis, Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Funisitis, Lung Disorder, Patent Ductus Arteriosus, Placental Disorder, Premature Baby | |||
| 1 | Day | F | 6252769 | 5243595 | 03/12/2000 | 02/20/2007 | Zoloft | OT | Anxiety, Depression | Congenital Central Nervous System Anomaly, Convulsion, Drug Exposure During Pregnancy | ||||
| 1 | Day | F | 6375644 | 5400226 | 03/06/2006 | 07/27/2007 | Zoloft | Postpartum Depression | Drug Exposure During Pregnancy, Fatigue, Fine Motor Delay, Personality Disorder, Speech Disorder Developmental, Transposition of the Great Vessels, Ventricular Hypoplasia | |||||
| 1 | Day | F | 6466835 | 5509912 | 09/23/2004 | 11/07/2007 | Zoloft | CN | Obsessive-Compulsive Disorder | Drug Exposure During Pregnancy, Hypopituitarism, Patent Ductus Arteriosus, Persistent Foetal Circulation, Ventricular Septal Defect | ||||
| 1 | Day | M | 6608055 | 5690115 | 09/06/2006 | 03/31/2008 | Zoloft | Depression | Colonic Obstruction, Drug Exposure During Pregnancy, Fallot's Tetralogy, Foetal Heart Rate Decreased | |||||
| 2 | Days | M | 5918671 | 4818974 | 04/10/2004 | 11/02/2005 | Zoloft | Postpartum Depression, Prophylaxis | Drug Exposure During Pregnancy, Hypoplastic Left Heart Syndrome | |||||
| 3 | Days | F | 5710733 | 4546117 | 10/08/2004 | 01/05/2005 | Sertraline | PH | Depression | Caesarean Section, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome Neonatal, Dyskinesia Neonatal, Failed Induction of Labour, Muscle Twitching, Neonatal Disorder, Tonic Clonic Movements, Tremor Neonatal | ||||
| 3 | Days | F | 6554631 | 5628724 | 02/15/2008 | Sertraline | MD | Depression | Diabetes Insipidus, Drug Exposure During Pregnancy, Jaundice Neonatal | |||||
| 4 | Days | M | 4149832 | 4366953 | 05/06/2004 | 05/24/2004 | Zoloft | MD | Depression | Agitation Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Fever Neonatal, Lethargy, Neonatal Disorder, Rash Neonatal | ||||
| 4 | Days | F | 6028166 | 4998520 | 01/01/2005 | 05/08/2006 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Muscle Spasms, Myoclonus, 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 | ||||
| 4 | Days | F | 6028166 | 4999954 | 01/01/2005 | 05/01/2006 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Muscle Spasms, Myoclonus, Premature Baby | ||||
| 5 | Days | M | 6220152 | 5178811 | 10/06/2006 | 12/08/2006 | Zoloft | MD | Choking, Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Jaundice Neonatal, Neonatal Disorder, Retching, Sinusitis | |||||
| 12 | Days | M | 5664881 | 4466398 | 01/01/2004 | 09/30/2004 | Zoloft | Anxiety | Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Heart Rate Increased, Insomnia, Medication Error, Muscle Twitching, Neonatal Disorder, Postmature Baby, Respiratory Rate Increased | |||||
| 13 | Days | F | 5785166 | 4641079 | 03/15/2005 | 04/19/2005 | 03/28/2005 | Zoloft | CN | Cleft Lip and Palate, Congenital Anomaly, Deformity, Drug Exposure During Pregnancy, Dysphagia, Ebstein's Anomaly, Horseshoe Kidney, Neonatal Disorder, Nervous System Disorder, Poor Sucking Reflex, Pulmonary Oedema Neonatal, Ventricular Septal Defect | ||||
| 19 | Days | F | 6541643 | 5611365 | 08/22/2007 | 02/01/2008 | Lustral | OT | Cleft Palate, Dehydration, Drug Exposure During Pregnancy, Irritability, Ventricular Septal Defect, Weight Decreased | |||||
| 19 | Days | F | 6541643 | 5623485 | 08/22/2007 | 02/12/2008 | Lustral | OT | Cleft Palate, Dehydration, Irritability, Ventricular Septal Defect, Weight Decreased | |||||
| 19 | Days | F | 6593112 | 5663890 | 03/11/2008 | Sertraline | OT | Cardiac Murmur, Dehydration, Drug Exposure During Pregnancy, Hypotonia Neonatal, Ill-Defined Disorder, Irritability, Lipoatrophy, Neonatal Disorder, Weight Decrease Neonatal | ||||||
| 2 | Months | M | 6518905 | 5580713 | 07/01/2007 | 01/03/2008 | Zoloft | OT | Depression | Agitation, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal | ||||
| 2 | Months | M | 6518905 | 5587356 | 07/01/2007 | 01/10/2008 | Zoloft | OT | Depression | Agitation, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal | ||||
| 4 | Months | M | 5890907 | 4781149 | 09/23/2005 | Zoloft | Ill-Defined Disorder | Body Temperature Increased, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Unevaluable Event | ||||||
| 4 | Months | M | 5890907 | 4781593 | 09/27/2005 | Zoloft | Ill-Defined Disorder | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea, Neonatal Disorder, Pyrexia | ||||||
| 23 | Weeks | M | 6498847 | 5534361 | 11/30/2007 | Sertraline | Drug Exposure During Pregnancy, Stillbirth | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6 | Months | 6330596 | 5352890 | 06/11/2007 | Zoloft | MD | Body Height Below Normal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Gastrooesophageal Reflux Disease, Weight Gain Poor | |||||||
| 6 | Months | M | 6330596 | 5389504 | 01/01/2006 | 07/17/2007 | Zoloft | MD | Depression | Body Height Below Normal, Drug Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Weight Gain Poor | ||||
| 1 | Year | M | 6271062 | 5276314 | 03/26/2007 | Zoloft | MD | Autism Spectrum Disorder, Drug Exposure During Pregnancy | ||||||
| 2 | Years | M | 6078995 | 5037096 | 06/23/2006 | Zoloft | CN | Depression | Cerebral Disorder, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Paresis, Presbyopia, Strabismus, Upper Respiratory Tract Infection | |||||
| 2 | Years | M | 6078995 | 5145917 | 01/01/2003 | 11/02/2006 | Zoloft | Depression | Cerebral Palsy, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus | |||||
| 4 | Years | M | 4035258 | 4277662 | 09/01/2003 | 01/21/2004 | Zoloft | Anxiety | Drug Exposure Via Breast Milk, Maternal Drugs Affecting Foetus, Sensory Integrative Dysfunction | |||||
| 4 | Years | M | 4035258 | 4280256 | 09/01/2003 | 01/26/2004 | Zoloft | Anxiety | Autism, Maternal Drugs Affecting Foetus, Sensory Integrative Dysfunction | |||||
| 16 | Years | F | 5837042 | 4713102 | 07/01/2005 | Zoloft | OT | Anxiety | Depression, Drug Exposure During Pregnancy, Intentional Misuse, Overdose, Suicide Attempt | |||||
| 17 | Years | F | 5983557 | 4899947 | 01/18/2006 | 01/31/2006 | Zoloft | Depression | Abdominal Pain Upper, Drug Exposure During Pregnancy, Premature Labour | |||||
| 17 | Years | F | 5983557 | 4919329 | 01/18/2006 | 02/16/2006 | Zoloft | Depression | Abdominal Pain Upper, Drug Exposure During Pregnancy, Premature Baby | |||||
| 17 | Years | F | 5983557 | 4983041 | 11/14/2005 | 04/20/2006 | Zoloft | MD | Depression | Abdominal Pain Upper, Chorioamnionitis, Drug Exposure During Pregnancy, Funisitis, Nausea, Placental Disorder, Premature Labour, Urine Ketone Body Present, Vomiting, Weight Decreased | ||||
| 18 | Years | F | 6055317 | 5007885 | 05/17/2006 | Zoloft | MD | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy, 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 | ||||
| 19 | Years | F | 4219244 | 4500891 | 08/31/2004 | 11/09/2004 | Zoloft | MD | Abnormal Behaviour, Impulse-Control Disorder | Abnormal Behaviour, Drug Exposure During Pregnancy, Impulse-Control Disorder, Refusal of Treatment By Patient, Stillbirth | ||||
| 20 | Years | F | 6202184 | 5170599 | 03/01/2006 | 12/05/2006 | Zoloft | OT | Schizophrenia | Condition Aggravated, Drug Exposure During Pregnancy, Schizophrenia | ||||
| 20 | Years | F | 6349436 | 5372616 | 03/20/2007 | 06/26/2007 | Sertraline | MD | Depression | Caesarean Section, Drug Exposure During Pregnancy, Hyperemesis Gravidarum, Premature Labour | ||||
| 21 | Years | F | 6068971 | 5022073 | 04/01/2006 | 06/05/2006 | Sertraline | OT | Anxiety | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 23 | Years | F | 5872665 | 4757711 | 01/01/2000 | 08/30/2005 | Zoloft | Bipolar Disorder, Bipolar I Disorder, Depression | Anxiety, Bipolar I Disorder, Condition Aggravated, Dizziness, Dyskinesia, Eyelid Ptosis, Haemorrhage, Insomnia, Nausea, Somnolence, Suicide Attempt, Tremor | |||||
| 23 | Years | F | 5872665 | 4771042 | 01/01/2000 | 09/14/2005 | Zoloft | Depression | Aggression, Anorexia, Anxiety, Crying, Depression, Disease Recurrence, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Galactorrhoea, Haemorrhage, Headache, Hormone Level Abnormal, Insomnia, Musculoskeletal Pain, Nausea, Somnolence, Suicide Attempt, Tremor, Vaginal Haemorrhage, Weight Decreased | |||||
| 23 | Years | F | 5872665 | 4804683 | 01/01/2000 | 10/17/2005 | Zoloft | Bipolar Disorder, Bipolar I Disorder, Depression | Abortion, Alcoholism, Amenorrhoea, Anorexia, Anxiety, Condition Aggravated, Crying, Depression, Disease Recurrence, Dizziness, Drug Exposure During Pregnancy, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Galactorrhoea, Haemorrhage, Headache, Hormone Level Abnormal, Insomnia, Irritability, Nausea, Skin Discolouration, Somnolence, Suicide Attempt, Tachycardia, Tremor, Vaginal Haemorrhage, Weight Decreased | |||||
| 23 | Years | F | 5872665 | 4823510 | 11/07/2005 | Zoloft | Depression | Abdominal Pain, Abortion Induced, Aggression, Alcoholism, Amenorrhoea, Anorexia, Anxiety, Bipolar Disorder, Condition Aggravated, Crying, Depression, Disease Recurrence, Dizziness, Drug Exposure During Pregnancy, Euphoric Mood, Eyelid Ptosis, Galactorrhoea, Haemorrhage, Headache, Hypothyroidism, Insomnia, Irritability, Movement Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Somnolence, Suicide Attempt, Tachycardia, Treatment Noncompliance, Tremor, Uterine Haemorrhage, Vaginal Haemorrhage, Vaginal Infection, Weight Decreased | ||||||
| 23 | Years | F | 5872665 | 4830570 | 11/15/2005 | Zoloft | Bipolar Disorder, Bipolar I Disorder, Depression | Abdominal Pain, Abortion, Aggression, Agonal Rhythm, Alcoholism, Anorexia, Anxiety, Bacterial Infection, Bipolar Disorder, Condition Aggravated, Crying, Depression, Disease Recurrence, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Facial Palsy, Galactorrhoea, Haemorrhage, Headache, Herpes Virus Infection, Hypothyroidism, Insomnia, Irritability, Menorrhagia, Mood Altered, Musculoskeletal Pain, Nausea, Neck Pain, Skin Discolouration, Somnolence, Suicide Attempt, Tachycardia, Tremor, Uterine Haemorrhage, Vaginal Haemorrhage, Vaginal Infection, Vaginitis Bacterial, Weight Decreased | ||||||
| 23 | Years | F | 5872665 | 4847658 | 12/05/2005 | Zoloft | Bipolar Disorder, Bipolar I Disorder, Depression | Abdominal Pain, Abortion, Aggression, Alcoholism, Anorexia, Anxiety, Bipolar I Disorder, Condition Aggravated, Crying, Decreased Appetite, Depression, Dizziness, Euphoric Mood, Eyelid Ptosis, Feeling Abnormal, Flatulence, Galactorrhoea, Genital Infection Bacterial, Headache, Hormone Level Abnormal, Hypothyroidism, Insomnia, Irritability, Memory Impairment, Menorrhagia, Menstrual Disorder, Menstruation Irregular, Mood Altered, Movement Disorder, Musculoskeletal Pain, Nausea, Neck Pain, Seborrhoeic Dermatitis, Skin Discolouration, Somnolence, Suicide Attempt, Tachycardia, Tremor, Uterine Haemorrhage, Vaginal Haemorrhage, Vaginal Infection, Weight Decreased | ||||||
| 23 | Years | F | 5962022 | 4877642 | 01/09/2006 | Zoloft | CN | Depression | Abdominal Pain, Abortion, Alcoholism, Amenorrhoea, Anorexia, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Depression, Disease Recurrence, Dizziness, Drug Dose Omission, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Flatulence, Galactorrhoea, Haemorrhage, Headache, Hormone Level Abnormal, Insomnia, Mania, Menstruation Irregular, Mood Altered, Musculoskeletal Pain, Nausea, Rash Macular, Seborrhoeic Dermatitis, Serratia Infection, Somnolence, Suicide Attempt, Tachycardia, Tremor, Uterine Haemorrhage, Vaginal Haemorrhage, Vaginal Infection, Vaginitis Bacterial, Weight Decreased | |||||
| 23 | Years | F | 5962022 | 4885813 | 01/17/2006 | Zoloft | Bipolar Disorder, Bipolar I Disorder, Depression | Abdominal Pain, Abortion, Agitation, Alcoholism, Amenorrhoea, Anxiety, Bipolar Disorder, Blood Pressure Decreased, Condition Aggravated, Crying, Decreased Appetite, Depression, Dizziness, Drug Dose Omission, Euphoric Mood, Eyelid Ptosis, Feeling Abnormal, Flatulence, Galactorrhoea, Haemorrhagic Disorder, Headache, Insomnia, Irritability, Mania, Menstruation Irregular, Mood Altered, Movement Disorder, Nausea, Neck Pain, Seborrhoeic Dermatitis, Skin Striae, Somnolence, Suicide Attempt, Tachycardia, Tremor, Vaginal Haemorrhage, Vaginitis Bacterial, Weight Decreased | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 23 | Years | F | 5962022 | 4996150 | 05/04/2006 | Zoloft | CN | Bipolar Disorder, Bipolar I Disorder, Depression | Abortion, Aggression, Agitation, Alcoholism, Amenorrhoea, Amnesia, Anorexia, Anxiety, Blood Pressure Decreased, Crying, Dizziness, Dyskinesia, Euphoric Mood, Eyelid Ptosis, Galactorrhoea, Headache, Hormone Level Abnormal, Inappropriate Schedule of Drug Administration, Influenza Like Illness, Insomnia, Irritability, Menstruation Irregular, Mood Altered, Nausea, Neck Pain, Seborrhoeic Dermatitis, Sinusitis, Somnolence, Suicide Attempt, Tachycardia, Treatment Noncompliance, Tremor, Vaginal Haemorrhage, Weight Decreased | |||||
| 23 | Years | F | 6051517 | 5003668 | 05/15/2006 | Zoloft | Depression | Abortion, Alcoholism, Amnesia, Anorexia, Anxiety, Bacterial Infection, Bipolar Disorder, Blood Pressure Decreased, Depression, Dizziness, Drug Exposure During Pregnancy, Euphoric Mood, Eyelid Ptosis, Galactorrhoea, Headache, Hypoaesthesia, Hypothyroidism, Influenza, Irritability, Mania, Musculoskeletal Pain, Nausea, Seborrhoeic Dermatitis, Sinusitis, Somnolence, Suicide Attempt, Tachycardia, Tremor, Uterine Haemorrhage, Vaginal Disorder, Vaginal Haemorrhage, Weight Decreased | ||||||
| 23 | Years | F | 6051517 | 5049123 | 07/06/2006 | Zoloft | Bipolar Disorder, Bipolar I Disorder, Depression | Abdominal Pain, Abortion, Aggression, Agitation, Alcoholism, Amenorrhoea, Amnesia, Anorexia, Anxiety, Bacterial Infection, Blood Pressure Decreased, Condition Aggravated, Depression, Disease Recurrence, Dizziness, Drug Exposure During Pregnancy, Dyskinesia, Euphoric Mood, Eye Disorder, Eyelid Ptosis, Flatulence, Galactorrhoea, Headache, Hormone Level Abnormal, Hypoaesthesia, Hypoaesthesia Facial, Hypothyroidism, Influenza, Insomnia, Irritability, Mania, Menstruation Irregular, Mood Altered, Nausea, Pain, Seborrhoeic Dermatitis, Sinusitis, Skin Discolouration, Somnolence, Suicide Attempt, Tachycardia, Tremor, Vaginal Haemorrhage, Vaginal Infection, Weight Decreased | ||||||
| 23 | Years | F | 6124800 | 5091541 | 07/29/2006 | 08/24/2006 | Zoloft | MD | Drug Use for Unknown Indication | Caesarean Section, Drug Exposure During Pregnancy, Pancreatitis Acute | ||||
| 23 | Years | F | 6155531 | 5131684 | 07/29/2006 | 10/16/2006 | Zoloft | MD | Caesarean Section, Drug Exposure During Pregnancy, Pancreatitis Acute | |||||
| 24 | Years | F | 5693729 | 4519265 | 06/01/2004 | 12/01/2004 | Zoloft | MD | Postpartum Depression | Drug Exposure During Pregnancy, Uterine Contractions During Pregnancy | ||||
| 24 | Years | F | 6171690 | 5147398 | 11/06/2006 | Zoloft | CN | Anxiety, Depression | Blood Cholesterol Increased, Drug Exposure During Pregnancy, Fatigue, Injury, Memory Impairment, Ventriculo-Peritoneal Shunt, Weight Increased | |||||
| 24 | Years | F | 6444156 | 5485583 | 10/02/2007 | 10/11/2007 | Zoloft | CN | Anxiety | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 24 | Years | F | 6466114 | 5507320 | 02/01/2006 | 11/02/2007 | Sertraline | Depression | Drug Exposure During Pregnancy | |||||
| 24 | Years | F | 6468500 | 5509580 | 02/01/2006 | 11/06/2007 | Sertraline | Depression | Drug Exposure During Pregnancy | |||||
| 24 | Years | F | 6470457 | 5513528 | 02/01/2006 | 11/08/2007 | Sertraline | OT | Depression | Drug Exposure During Pregnancy | ||||
| 24 | Years | F | 6470457 | 5612192 | 02/01/2006 | 01/28/2008 | Sertraline | 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 | ||||
| 24 | Years | F | 6472141 | 5512811 | 02/01/2006 | 11/08/2007 | Sertraline | Depression | Drug Exposure During Pregnancy | |||||
| 24 | Years | F | 6684398 | 5776997 | 01/01/2007 | 06/16/2008 | Sertraline | OT | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus | ||||
| 25 | Years | F | 6521489 | 5578266 | 12/27/2007 | Sertraline | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy | ||||||
| 25 | Years | F | 6521489 | 5580027 | 12/28/2007 | Sertraline | OT | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy | |||||
| 25 | Years | F | 6521489 | 5613444 | 01/29/2008 | Sertraline | OT | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy | |||||
| 25 | Years | F | 6522402 | 5581177 | 12/27/2007 | Sertraline | Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy | |||||||
| 25 | Years | F | 6523154 | 5580192 | 12/28/2007 | Sertraline | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Drug Interaction, Ectopic Pregnancy | ||||||
| 25 | Years | F | 6549133 | 5621060 | 01/18/2008 | 02/08/2008 | Zoloft | MD | Panic Attack | Abortion | ||||
| 25 | Years | F | 6549133 | 5628514 | 01/18/2008 | 02/15/2008 | Zoloft | MD | Panic Attack | Abortion | ||||
| 25 | Years | F | 6032120 | 4974599 | 12/01/2004 | 04/10/2006 | Zoloft | Depression | Depression, Drug Exposure During Pregnancy, Eclampsia, Gestational Diabetes, Pre-Eclampsia, Premature Baby | |||||
| 26 | Years | F | 6481228 | 5530338 | 03/01/2005 | 11/27/2007 | Zoloft | Obsessive-Compulsive Disorder | Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy | |||||
| 26 | Years | F | 5657464 | 4486436 | 07/16/2004 | 10/26/2004 | Zoloft | CN | Anxiety | Adjustment Disorder, Fear, Homicidal Ideation, Postpartum Depression, Psychotic Disorder, Suicidal Ideation, Thyroiditis | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 26 | Years | F | 5710456 | 4541828 | 01/01/2004 | 12/27/2004 | Zoloft | MD | Depression | Antepartum Haemorrhage, Anxiety, Arrested Labour, Caesarean Section, Drug Exposure During Pregnancy, Placenta Praevia, Umbilical Cord Around Neck, Weight Increased | ||||
| 26 | Years | F | 6138203 | 5112883 | 09/01/2006 | 09/21/2006 | Sertraline | OT | Dehydration, Diarrhoea, Drug Exposure During Pregnancy, Headache, Therapeutic Response Unexpected With Drug Substitution | |||||
| 27 | Years | F | 6059314 | 5030599 | 06/15/2006 | Zoloft | Bipolar I Disorder | Crying, Depressed Mood, Drug Exposure Before Pregnancy, Feeling Abnormal, Irritability, Mood Altered, Post-Traumatic Stress Disorder, Uterine Leiomyoma | ||||||
| 28 | Years | F | 4131352 | 4342388 | 03/01/2004 | 04/16/2004 | Zoloft | Anxiety | Complications of Maternal Exposure To Therapeutic Drugs, Intra-Uterine Death, Maternal Drugs Affecting Foetus | |||||
| 28 | Years | F | 4131352 | 4360018 | 03/01/2004 | 05/13/2004 | Zoloft | MD | Anxiety | Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Maternal Drugs Affecting Foetus | ||||
| 28 | Years | F | 4156847 | 4375996 | 06/07/2004 | Sertraline | PH | Obsessive-Compulsive Disorder | Abortion Spontaneous, Maternal Drugs Affecting Foetus | |||||
| 28 | Years | F | 4161076 | 4382172 | 01/01/2002 | 06/15/2004 | Zoloft | OT | Depression | Drug Dependence, Drug Effect Decreased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Emotional Distress, Nausea | ||||
| 28 | Years | F | 5693327 | 4517772 | 11/13/2004 | 11/30/2004 | Zoloft | MD | Depression | Caesarean Section, Drug Exposure During Pregnancy, Stillbirth | ||||
| 28 | Years | F | 5906034 | 4802057 | 10/11/2005 | Zoloft | PH | Ill-Defined Disorder | Caesarean Section, Drug Exposure During Pregnancy | |||||
| 28 | Years | F | 5906034 | 4835877 | 09/13/2005 | 11/18/2005 | Zoloft | PH | Depression | Caesarean Section, Drug Exposure During Pregnancy | ||||
| 28 | Years | F | 5940968 | 4916755 | 11/02/2005 | 02/14/2006 | Sertraline | MD | Obsessive-Compulsive Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 28 | Years | F | 6600980 | 5674789 | 03/19/2008 | 01/12/2008 | Zoloft | Insomnia | Completed Suicide, 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 | ||||
| 29 | Years | F | 6531530 | 5592901 | 01/14/2008 | Zoloft | CN | Developmental Delay, Drug Exposure During Pregnancy, Dyspraxia, Sensory Integrative Dysfunction | ||||||
| 29 | Years | F | 3642770 | 4332404 | 12/01/2000 | 04/01/2004 | Zoloft | Depression | Complications of Maternal Exposure To Therapeutic Drugs, Intra-Uterine Death, Maternal Drugs Affecting Foetus | |||||
| 29 | Years | F | 4159927 | 4381198 | 06/16/2004 | Zoloft | MD | Anxiety | Beta Haemolytic Streptococcal Infection, Complications of Maternal Exposure To Therapeutic Drugs, Premature Rupture of Membranes | |||||
| 29 | Years | F | 4201465 | 4433755 | 01/01/2004 | 08/25/2004 | Zoloft | MD | Depression | Abortion Induced, Drug Exposure During Pregnancy | ||||
| 29 | Years | F | 5847803 | 4720538 | 07/19/2005 | Zoloft | Panic Attack, Social Phobia | Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes | ||||||
| 30 | Years | F | 4161222 | 4382251 | 06/15/2004 | Zoloft | MD | Depression | Beta Haemolytic Streptococcal Infection, Caesarean Section, Drug Exposure During Pregnancy, Vaginal Infection | |||||
| 30 | Years | F | 5693801 | 4515663 | 06/10/2003 | 11/26/2004 | Zoloft | OT | Depression | Breech Delivery, Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Macrocephaly, Maternal Drugs Affecting Foetus | ||||
| 30 | Years | F | 5960868 | 4875056 | 12/06/2005 | 01/04/2006 | Sertraline | MD | Ill-Defined Disorder | Caesarean Section, Drug Exposure During Pregnancy | ||||
| 30 | Years | F | 5974374 | 4890813 | 01/23/2006 | Zoloft | Anxiety, Migraine | Caesarean Section, Drug Exposure During Pregnancy, Pain, Rheumatoid Factor Increased | ||||||
| 30 | Years | F | 6025518 | 4963652 | 02/04/2006 | 03/30/2006 | Sertraline | OT | Depression | Abortion Missed, Drug Exposure During Pregnancy | ||||
| 30 | Years | F | 6125205 | 5096888 | 05/15/2004 | 09/01/2006 | Zoloft | OT | Postpartum Depression | Abnormal Behaviour, Amnesia, Attention Deficit Hyperactivity Disorder, Bipolar Disorder, Condition Aggravated, Depression, Drug Exposure Before Pregnancy, Hormone Level Abnormal, Ill-Defined Disorder, Imprisonment, Mania, Panic Attack, Personality Change, Thyroid Disorder | ||||
| 31 | Years | F | 5829949 | 4719518 | 07/19/2005 | Zoloft | MD | Postpartum Depression | Abortion Spontaneous, Bipolar Disorder, Caesarean Section, Chlamydial Infection, Depression, Drug Exposure During Pregnancy, Feeling Abnormal, Hallucination (Auditory), Laceration, Mood Swings, Oral Intake Reduced, Psychomotor Hyperactivity, Somnolence, Suicidal Ideation, Suicide Attempt, Weight Decreased, 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 | ||||
| 31 | Years | F | 6643311 | 5742447 | 08/28/2007 | 05/19/2008 | Sertraline | MD | Anxiety | Abortion Spontaneous | ||||
| 31 | Years | F | 6659304 | 5753049 | 08/28/2007 | 05/27/2008 | Sertraline | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 31 | Years | F | 6660692 | 5753386 | 08/28/2007 | 05/27/2008 | Sertraline | Anxiety, Drug Exposure During Pregnancy | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 31 | Years | F | 6661416 | 5755509 | 08/28/2007 | 05/28/2008 | Sertraline | MD | Anxiety, Depression | Abortion Spontaneous, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus | ||||
| 31 | Years | F | 6663068 | 5753418 | 08/28/2007 | 05/27/2008 | Sertraline | Anxiety, Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 31 | Years | F | 6684413 | 5777009 | 08/28/2007 | 06/16/2008 | Sertraline | Anxiety, Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 32 | Years | F | 5728802 | 4564161 | 08/01/2004 | 01/26/2005 | Lustral | OT | Depression | Depression, Drug Exposure During Pregnancy, Drug Tolerance Decreased, Ectopic Pregnancy | ||||
| 32 | Years | F | 5808436 | 4674029 | 05/25/2005 | Sertraline | MD | Drug Exposure During Pregnancy, Premature Labour | ||||||
| 32 | Years | F | 5846987 | 4718864 | 07/19/2005 | Gladem | MD | Depression | Abortion Early, Drug Exposure During Pregnancy, Ectopic Pregnancy | |||||
| 32 | Years | F | 6090079 | 5053208 | 07/12/2006 | Sertraline | OT | Major Depression | Decreased Appetite, Drug Exposure During Pregnancy, Oral Intake Reduced, Weight Gain Poor | |||||
| 32 | Years | F | 6145615 | 5120242 | 01/17/2006 | 09/28/2006 | Zoloft | MD | Depression | Abortion Missed, Drug Exposure During Pregnancy | ||||
| 32 | Years | F | 6187346 | 5164627 | 11/03/2006 | 11/24/2006 | Zoloft | MD | Affective Disorder | Caesarean Section, 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 | ||||
| 33 | Years | F | 5684967 | 4507390 | 01/01/2004 | 11/18/2004 | Zoloft | MD | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy, Paraesthesia, Sensory Loss, Swelling Face | ||||
| 33 | Years | F | 5773820 | 4627072 | 03/31/2005 | Zoloft | MD | Ill-Defined Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy, Unwanted Pregnancy | |||||
| 33 | Years | F | 5812680 | 4678929 | 07/01/2004 | 05/31/2005 | Zoloft | PH | Aggression, Drug Exposure During Pregnancy, Nausea, Vomiting | |||||
| 33 | Years | F | 6021868 | 4957779 | 03/24/2006 | Zoloft | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Intra-Uterine Death | |||||
| 33 | Years | F | 6021868 | 4988993 | 04/25/2006 | Zoloft | MD | Ill-Defined Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy, Foetal Heart Rate Abnormal | |||||
| 33 | Years | F | 6052218 | 5003343 | 02/24/2006 | 05/12/2006 | Zoloft | OT | Obsessive-Compulsive Disorder | Caesarean Section, Drug Exposure During Pregnancy | ||||
| 33 | Years | F | 6141550 | 5131806 | 10/16/2006 | Zoloft | MD | Abortion Spontaneous, Anxiety, Drug Exposure During Pregnancy | ||||||
| 34 | Years | F | 5907032 | 4816400 | 02/09/2000 | 10/28/2005 | Tresleen | MD | Anxiety, Depression | Assisted Fertilisation, Drug Exposure During Pregnancy, Hypothyroidism | ||||
| 35 | Years | F | 4088934 | 4287086 | 09/01/2003 | 02/05/2004 | Zoloft | Depression | Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Ectopic Pregnancy, Haemorrhage, Laboratory Test Abnormal, Maternal Drugs Affecting Foetus, Obsessive Thoughts, Progesterone Decreased | |||||
| 35 | Years | F | 4088934 | 4304327 | 09/01/2003 | 02/24/2004 | Zoloft | Depression | Abortion Spontaneous, Blood Human Chorionic Gonadotropin Decreased, Complications of Maternal Exposure To Therapeutic Drugs, Ectopic Pregnancy, Maternal Drugs Affecting Foetus, Progesterone Decreased | |||||
| 35 | Years | F | 4148186 | 4365328 | 01/01/2003 | 05/20/2004 | Zoloft | MD | Anxiety, Depression | Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy | ||||
| 36 | Years | F | 5650690 | 4476497 | 10/12/2004 | Zoloft | OT | Depression | Anaemia, Caesarean Section, Depression, Dizziness, Drug Exposure During Pregnancy, Hypoaesthesia, Urinary Tract Infection, Uterine Leiomyoma | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 36 | Years | F | 5650690 | 4494980 | 11/03/2004 | Zoloft | OT | Depression | Abdominal Pain, Anaemia, Caesarean Section, Dizziness, Hypoaesthesia, Sensation of Pressure, Urinary Tract Infection, Uterine Leiomyoma | |||||
| 36 | Years | F | 5741846 | 4576818 | 10/25/2004 | 02/07/2005 | Zoloft | Depression | Amniotic Fluid Volume Increased, Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Glycosylated Haemoglobin Decreased, Pre-Eclampsia, Premature Labour, Premature Rupture of Membranes | |||||
| 36 | Years | F | 5741846 | 4620605 | 10/25/2004 | 03/24/2005 | Zoloft | MD | Depression | Amniotic Fluid Volume Increased, Caesarean Section, Drug Exposure During Pregnancy, Fluid Retention, Glycosylated Haemoglobin Increased, High Risk Pregnancy, Pre-Eclampsia, Premature Labour, Weight Decreased | ||||
| 36 | Years | F | 5948522 | 4851808 | 01/01/2005 | 12/09/2005 | Zoloft | Schizoaffective Disorder | Disease Recurrence, Drug Exposure During Pregnancy, Mania, Pre-Eclampsia, Weight Increased | |||||
| 36 | Years | F | 6012195 | 4947467 | 05/01/2004 | 03/13/2006 | Zoloft | Depression | Caesarean Section, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome, Feeling Abnormal, Insomnia, Nausea, Neuralgia, Obstetric Procedure Complication, Pain, Placenta Praevia, Premature Labour, Tremor, Weight Increased | |||||
| 36 | Years | F | 6229794 | 5227777 | 02/02/2007 | Zoloft | MD | Abortion Spontaneous | ||||||
| 36 | Years | F | 6229794 | 5267669 | 03/16/2007 | Zoloft | MD | Major Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 36 | Years | F | 6265283 | 5256922 | 12/19/2003 | 03/05/2007 | Zoloft | OT | Depression, Postpartum Depression | Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Ventricular Septal Defect | ||||
| 36 | Years | F | 6491711 | 5546857 | 01/01/2000 | 12/11/2007 | Zoloft | OT | Drug Exposure During Pregnancy, Synostosis | |||||
| 36 | Years | F | 6511888 | 5570240 | 09/01/2007 | 12/20/2007 | Zoloft | MD | Depression | Drug Ineffective, Postpartum Haemorrhage | ||||
| 37 | Years | F | 6464140 | 5506142 | 04/14/2007 | 11/01/2007 | Sertraline | Depression | Drug Exposure During Pregnancy, Premature Labour, Stillbirth, Vaginal Haemorrhage | |||||
| 37 | Years | F | 6465744 | 5507490 | 04/14/2007 | 11/02/2007 | Sertraline | MD | Depression | Antepartum Haemorrhage, Drug Exposure During Pregnancy, Premature Baby, Rubella, Stillbirth | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 37 | Years | F | 6466224 | 5507322 | 11/02/2007 | Sertraline | Depression | Stillbirth, Vaginal Haemorrhage | ||||||
| 37 | Years | F | 6466224 | 5512563 | 11/07/2007 | Sertraline | OT | Depression | Drug Exposure During Pregnancy, Stillbirth, Vaginal Haemorrhage | |||||
| 37 | Years | F | 6469579 | 5511088 | 11/07/2007 | Sertraline | Depression | Drug Exposure During Pregnancy, Stillbirth, Vaginal Haemorrhage | ||||||
| 37 | Years | F | 6469607 | 5511059 | 04/14/2007 | 11/07/2007 | Sertraline | Depression | Drug Exposure During Pregnancy, Rubella Antibody Positive, Stillbirth, Vaginal Haemorrhage | |||||
| 37 | Years | F | 6498857 | 5534362 | 04/14/2007 | 11/30/2007 | Sertraline | Depression | Drug Exposure During Pregnancy, Premature Baby, Rubella Antibody Positive, Stillbirth, Vaginal Haemorrhage | |||||
| 37 | Years | F | 4225168 | 4463861 | 05/10/2004 | 09/29/2004 | Zoloft | MD | Depression | Abortion Missed, Depression, Drug Exposure During Pregnancy | ||||
| 37 | Years | F | 5840305 | 4712375 | 12/01/2004 | 07/11/2005 | Zoloft | Ill-Defined Disorder | Drug Exposure During Pregnancy, Pre-Eclampsia, Premature Labour, Stillbirth | |||||
| 37 | Years | F | 5876562 | 4764063 | 01/01/2005 | 09/06/2005 | Zoloft | Ill-Defined Disorder | Caesarean Section, Drug Exposure During Pregnancy, Insomnia, Road Traffic Accident, Stress, Surgery, Vertigo | |||||
| 37 | Years | F | 5876562 | 4789640 | 01/01/2005 | 10/04/2005 | Zoloft | Depression | Drug Ineffective, Hypersomnia, Limb Operation, Oligomenorrhoea, Road Traffic Accident, Sinusitis, Stress, Vertigo | |||||
| 37 | Years | F | 5981214 | 4899758 | 01/31/2006 | Zoloft | Depression | Caesarean Section, Drug Exposure During Pregnancy, Menstrual Disorder, Metrorrhagia, Migraine, Ovarian Cyst, Pain, Panic Attack, Umbilical Cord Around Neck, Uterine Cyst, Uterine Leiomyoma, Vomiting In Pregnancy | ||||||
| 37 | Years | F | 6132133 | 5103144 | 08/01/2006 | 09/08/2006 | Zoloft | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome | |||||
| 37 | Years | F | 6207593 | 5179885 | 12/11/2006 | Sertraline | MD | Anxiety, Depression, Panic Reaction | Blood Pressure Increased, Caesarean Section, Drug Ineffective, Placenta Praevia, Vaginal Haemorrhage | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 37 | Years | F | 6659609 | 5749248 | 01/08/2007 | 05/21/2008 | 07/25/2007 | Zoloft | OT | Depression | Drug Exposure During Pregnancy | |||
| 38 | Years | F | 6534542 | 5601838 | 06/07/2007 | 01/24/2008 | Zoloft | MD | Depression | Intra-Uterine Death | ||||
| 38 | Years | F | 5907032 | 4803689 | 10/14/2005 | Tresleen | MD | Anxiety | Autoimmune Thyroiditis, Drug Exposure During Pregnancy | |||||
| 38 | Years | F | 6180007 | 5157947 | 02/01/2006 | 11/16/2006 | Zoloft | CN | Depression, Panic Disorder | Abdominal Pain Lower, Amnesia, Anxiety, Confusional State, Crying, Disturbance In Attention, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Ineffective, Emotional Disorder, Feeling Abnormal, Ill-Defined Disorder, Impaired Driving Ability, Judgement Impaired, Major Depression, Malaise, Muscle Twitching, Nervous System Disorder, Optic Neuritis, Pain, Photophobia, Postpartum Depression, Suicidal Ideation, Vision Blurred, Visual Disturbance, Weight Decreased | ||||
| 40 | Years | F | 5865696 | 4748517 | 08/17/2005 | 08/18/2005 | Zoloft | CN | Anxiety, Depression | Crying, Depression, Disorientation, Dizziness, Drug Dose Omission, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Abnormal, Hallucination (Auditory), Insomnia, Irritability, Mental Disorder, Tinnitus | ||||
| 40 | Years | F | 6124649 | 5092504 | 08/28/2006 | Zoloft | Depression | Anxiety, Diarrhoea, Drug Exposure During Pregnancy, Dyskinesia, Memory Impairment, Ovarian Cancer, Tremor | ||||||
| 41 | Years | F | 4152267 | 4417291 | 01/01/2001 | 08/02/2004 | Zoloft | OT | Depression | Blood Pressure Decreased, Bruxism, Cardiac Failure Congestive, Cardiomyopathy, Drug Exposure During Pregnancy, Fatigue, Glucose Tolerance Impaired, Tooth Fracture | ||||
| 42 | Years | F | 5697930 | 4523140 | 10/24/2004 | 12/08/2004 | Zoloft | MD | Ill-Defined Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy, Pyrexia | ||||
| 42 | Years | F | 5798649 | 4658525 | 01/01/2005 | 05/09/2005 | Zoloft | MD | Abortion Spontaneous, Contusion, Drug Exposure During Pregnancy, Haemorrhage | |||||
| 103 Males | 226 Females | 410 Cases (Gender was not reported for 81 Cases) | 537 Individual Safety Reports | |||||||||||
Daxid (sertraline), Gladem (sertraline), Lustral (sertraline), Serlain (sertraline), Sertraline (sertraline), Tresleen (sertraline), Zoloft (sertraline)
Abdominal Pain, Abdominal Pain Lower, Abdominal Pain Upper, Abnormal Behaviour, Abnormal Labour, Abnormal Palmar/Plantar Creases, Abortion, Abortion Early, Abortion Induced, Abortion Missed, Abortion Spontaneous, Adenocarcinoma, Adenotonsillectomy, Adjustment Disorder, Affective Disorder, Aggression, Agitation, Agitation Neonatal, Agonal Rhythm, Alcoholism, Alpha 1 Foetoprotein Amniotic Fluid Increased, Alpha 1 Foetoprotein Increased, Amenorrhoea, Amnesia, Amniotic Fluid Volume Decreased, Amniotic Fluid Volume Increased, Anaemia, Anal Atresia, Anencephaly, Anger, Angiopathy, Ankyloglossia Congenital, Anomalous Pulmonary Venous Connection, Anomaly of External Ear Congenital, Anorectal Disorder, Ano-Rectal Stenosis, Anorexia, Antepartum Haemorrhage, Antiphospholipid Syndrome, Anxiety, Aortic Disorder, Aortic Elongation, Aortic Stenosis, Aortic Valve Incompetence, Aortic Valve Stenosis, Apgar Score Low, Apnoea, Appendicectomy, Arrested Labour, Arrhythmia Neonatal, Arterial Disorder, Arthritis, Arthropathy, Asplenia, Assisted Fertilisation, Asthma, Atrial Septal Defect, Atrioventricular Septal Defect, Attention Deficit Hyperactivity Disorder, Attention Deficit/Hyperactivity Disorder, Auricular Swelling, Autism, Autism Spectrum Disorder, Autoimmune Thyroiditis, Back Pain, Bacterial Infection, Bed Rest, Benign Hydatidiform Mole, Beta Haemolytic Streptococcal Infection, Bicuspid Aortic Valve, Bipolar Disorder, Bipolar I Disorder, Birth Trauma, Blindness, Blood Bilirubin Increased, Blood Cholesterol Increased, Blood Glucose Abnormal, Blood Glucose Decreased, Blood Human Chorionic Gonadotropin Decreased, Blood Magnesium Decreased, Blood PH Decreased, Blood Pressure Decreased, Blood Pressure Increased, Blood Pressure Systolic Decreased, Blood Prolactin Increased, Body Height Below Normal, Body Temperature Decreased, Body Temperature Increased, Bone Disorder, Bradycardia, Bradycardia Foetal, Bradycardia Neonatal, Brain Damage, Brain Malformation, Breast Pain, Breech Delivery, Breech Presentation, Bronchitis, Bruxism, Burning Sensation, Caesarean Section, Cardiac Arrest, Cardiac Disorder, Cardiac Failure, Cardiac Failure Congestive, Cardiac Murmur, Cardiac Perforation, Cardiac Septal Defect, Cardiac Valve Disease, Cardiomegaly, Cardiomyopathy, Caudal Regression Syndrome, Cephalhaematoma, Cerebellar Hypoplasia, Cerebral Cyst, Cerebral Disorder, Cerebral Haemorrhage, Cerebral Haemorrhage Neonatal, Cerebral Palsy, Cerebral Ventricle Dilatation, Cerebrovascular Accident, Chlamydial Infection, Choking, Cholecystectomy, Chorioamnionitis, Chromosome Abnormality, Circulatory Failure Neonatal, Clavicle Fracture, Cleft Lip, Cleft Lip and Palate, Cleft Palate, Coarctation of the Aorta, Cognitive Disorder, Collapse of Lung, Colonic Obstruction, Coma, Complement Factor C4, Complement Factor C4 Decreased, Completed Suicide, Complications of Maternal Exposure To Therapeutic Drugs, Compression Fracture, Condition Aggravated, Confusional State, Congenital Absence of Bile Ducts, Congenital Absence of Cranial Vault, Congenital Anomaly, Congenital Arterial Malformation, Congenital Brain Damage, Congenital Cardiovascular Anomaly, Congenital Central Nervous System Anomaly, Congenital Diaphragmatic Anomaly, Congenital Diaphragmatic Hernia, Congenital Foot Malformation, Congenital Great Vessel Anomaly, Congenital Hand Malformation, Congenital Heart Valve Disorder, Congenital Macrocephaly, Congenital Neurological Disorder, Congenital Nose Malformation, Congenital Nystagmus, Congenital Oesophageal Web, Congenital Pulmonary Hypertension, Congenital Pulmonary Valve Atresia, Congenital Tricuspid Valve Atresia, Constipation, Contusion, Convulsion, Convulsion Neonatal, Coombs Direct Test Positive, Coombs Test Positive, Craniosynostosis, Croup Infectious, Crying, Cyanosis, Cyanosis Neonatal, Dacryostenosis Congenital, Deafness, Death, Death Neonatal, Decreased Appetite, Deformity, Dehydration, Dental Caries, Depersonalisation, Depressed Mood, Depression, Developmental Coordination Disorder, Developmental Delay, Dextrocardia, Diabetes Insipidus, Diarrhoea, DiGeorge's Syndrome, Discomfort, Disease Recurrence, Disorientation, Disturbance In Attention, Divorced, Dizziness, Double Outlet Right Ventricle, Drug Dependence, Drug Dose Omission, Drug Effect Decreased, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Interaction, Drug Intolerance, Drug Level Increased, Drug Tolerance Decreased, Drug Toxicity, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dyskinesia, Dyskinesia Neonatal, Dyspepsia, Dysphagia, Dyspnoea, Dyspraxia, Ear Infection, Ear Malformation, Ebstein's Anomaly, Eclampsia, Economic Problem, Ectopic Pregnancy, Ectopic Pregnancy Termination, Eczema, Electroencephalogram Abnormal, Emotional Disorder, Emotional Distress, Enamel Anomaly, Encephalitis, Encephalopathy Neonatal, Endometriosis, Epilepsy, Euphoric Mood, Exomphalos, Eye Disorder, Eye Movement Disorder, Eye Rolling, Eyelid Ptosis, Facial Palsy, Failed Induction of Labour, Failure To Thrive, Fall, Fallot's Tetralogy, False Labour, Fatigue, Fear, Feeding Disorder Neonatal, Feeding Disorder of Infancy or Early Childhood, Feeling Abnormal, Feeling Jittery, Fever Neonatal, Fine Motor Delay, Flatulence, Fluid Overload, Fluid Retention, Foetal Cardiac Disorder, Foetal Damage, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate, Foetal Heart Rate Abnormal, Foetal Heart Rate Decreased, Foetal Malformation, Food Allergy, Formication, Funisitis, Galactorrhoea, Gastric Disorder, Gastroenteritis Eosinophilic, Gastrointestinal Disorder, Gastrointestinal Malformation, Gastrooesophageal Cancer, Gastrooesophageal Reflux Disease, Genital Infection Bacterial, Gestational Diabetes, Glucose Tolerance Impaired, Glycosylated Haemoglobin Decreased, Glycosylated Haemoglobin Increased, Grand Mal Convulsion, Grip Strength Decreased, Growth Retardation, Grunting, Haemangioma, Haematochezia, Haematocrit Decreased, Haematoma, Haemorrhage, Haemorrhagic Disorder, Hallucination, Hallucination (Auditory), Head Deformity, Head Injury, Headache, Hearing Impaired, Heart Disease Congenital, Heart Rate Increased, Heart Valve Incompetence, Hellp Syndrome, Hepatic Congestion, Herpes Virus Infection, High Risk Pregnancy, Homicidal Ideation, Hormone Level Abnormal, Horseshoe Kidney, Hot Flush, Hunger, Hydronephrosis, Hyperemesis Gravidarum, Hyperphagia, Hyperreflexia, Hypersensitivity, Hypersomnia, Hypertelorism of Orbit, Hypertension, Hypertonia, Hypertonia Neonatal, Hypertrophy, Hyperventilation, Hypervigilance, Hypoaesthesia, Hypoaesthesia Facial, Hypocalcaemia, Hypoglycaemia, Hypoglycaemia Neonatal, Hypokinesia, Hypomagnesaemia, Hypopituitarism, Hypoplastic Left Heart Syndrome, Hypoplastic Right Heart Syndrome, Hypopnoea, Hypospadias, Hypothalamo-Pituitary Disorder, Hypothermia Neonatal, Hypothyroidism, Hypotonia, Hypotonia Neonatal, Hypoxia, Ill-Defined Disorder, Impaired Driving Ability, Imprisonment, Impulse-Control Disorder, Inappropriate Antidiuretic Hormone Secretion, Inappropriate Schedule of Drug Administration, Indirect Infection Transmission, Infantile Apnoeic Attack, Infertility, Inflammation, Influenza, Influenza Like Illness, Injury, Insomnia, Intentional Misuse, Intentional Self-Injury, Intercostal Retraction, Intra-Uterine Death, Irritability, Irritable Bowel Syndrome, Jaundice, Jaundice Neonatal, Joint Dislocation, Judgement Impaired, Kidney Enlargement, Laboratory Test Abnormal, Laboratory Test Interference, Labour Complication, Laceration, Large for Dates Baby, Laryngeal Stenosis, Laryngomalacia, Lethargy, Limb Deformity, Limb Malformation, Limb Operation, Limb Reduction Defect, Lipoatrophy, Liver Disorder, Lower Limb Deformity, Lung Disorder, Macrocephaly, Major Depression, Malaise, Malnutrition, Mania, Maternal Alcohol Use, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Maternal Use of Illicit Drugs, Medication Error, Memory Impairment, Menorrhagia, Menstrual Disorder, Menstruation Irregular, Mental Disorder, Mental Retardation Severity Unspecified, Mentally Late Developer, Metrorrhagia, Microcephaly, Migraine, Mild Mental Retardation, Mitral Valve Disease, Mitral Valve Hypoplasia, Mitral Valve Incompetence, Mitral Valve Prolapse, Mixed Receptive-Expressive Language Disorder, Mood Altered, Mood Swings, Movement Disorder, Multiple Allergies, Multiple Cardiac Defects, Multiple Congenital Abnormalities, Muscle Rigidity, Muscle Spasms, Muscle Twitching, Musculoskeletal Pain, Myoclonic Epilepsy, Myoclonus, Myotonia, Nasopharyngitis, Nausea, Neck Pain, Neonatal Apnoeic Attack, Neonatal Asphyxia, Neonatal Aspiration, Neonatal Complications of Substance Abuse, Neonatal Disorder, Neonatal Hypoxia, Neonatal Respiratory Acidosis, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Failure, Neonatal Tachycardia, Neonatal Tachypnoea, Nervous System Disorder, Nervousness, Neural Tube Defect, Neuralgia, Neurodevelopmental Disorder, Nightmare, Nystagmus, Oblique Presentation, Obsessive Thoughts, Obstetric Procedure Complication, Oligohydramnios, Oligomenorrhoea, Opisthotonus, Optic Neuritis, Oral Intake Reduced, Organ Failure, Osteoporosis, Otitis Media, Ovarian Cancer, Ovarian Cyst, Overdose, Overweight, Oxygen Saturation Decreased, Pain, Pain In Extremity, Palpitations, Pancreatitis Acute, Panic Attack, Paraesthesia, Paralysis, Paresis, Partial Seizures, Patent Ductus Arteriosus, Pericardial Effusion, Perinatal Brain Damage, Persistent Foetal Circulation, Personality Change, Personality Disorder, Phaeochromocytoma, Phobia, Photophobia, Placenta Praevia, Placental Disorder, Plasminogen Activator Inhibitor, Pleural Effusion, Pneumonia, Pneumonia Bacterial, Poisoning, Polydactyly, Polyhydramnios, Poor Sucking Reflex, Post Procedural Complication, Postmature Baby, Postpartum Depression, Postpartum Haemorrhage, Post-Traumatic Stress Disorder, Posture Abnormal, Pre-Eclampsia, Premature Baby, Premature Labour, Premature Rupture of Membranes, Premenstrual Syndrome, Presbyopia, Progesterone Decreased, Prolonged Labour, Psychomotor Hyperactivity, Psychomotor Skills Impaired, Psychotic Disorder, Pulmonary Artery Atresia, Pulmonary Hypertension, Pulmonary Hypoplasia, Pulmonary Oedema Neonatal, Pulmonary Valve Incompetence, Pulmonary Valve Stenosis, Pyloric Stenosis, Pyrexia, Rash Macular, Rash Neonatal, Reflexes Abnormal, Refusal of Treatment By Patient, Renal Aplasia, Renal Cyst, Renal Disorder, Renal Impairment, Renal Tubular Necrosis, Respiration Abnormal, Respiratory Depression, Respiratory Disorder, Respiratory Disorder Neonatal, Respiratory Distress, Respiratory Rate Increased, Respiratory Tract Infection, Restlessness, Retching, Retroplacental Haematoma, Rheumatoid Factor Increased, Rhinitis, Right Ventricular Hypertrophy, Road Traffic Accident, Rubella, Rubella Antibody Positive, Scar, Schizophrenia, Schizophrenia (Paranoid Type), Scoliosis, Seborrhoeic Dermatitis, Sedation, Sensation of Pressure, Sensory Integrative Dysfunction, Sensory Loss, Serotonin Syndrome, Serratia Infection, Shock, Single Functional Kidney, Sinusitis, Skin Burning Sensation, Skin Discolouration, Skin Lesion, Skin Striae, Skull Malformation, Sleep Apnoea Syndrome, Sleep Disorder, Sleep Study Abnormal, Small for Dates Baby, Snoring, Somnolence, Somnolence Neonatal, Speech Disorder, Speech Disorder Developmental, Spinal Deformity, Spine Malformation, Stillbirth, Strabismus, Strabismus Congenital, Stress, Sudden Death, Suicidal Ideation, Suicide Attempt, Supravalvular Aortic Stenosis, Supraventricular Tachycardia, Surgery, Swelling Face, Syncope, Syncope Vasovagal, Syndactyly, Synostosis, Tachycardia, Tachypnoea, Takayasu's Arteritis, Talipes, Tardive Dyskinesia, Tendonitis, Thalassaemia, Therapeutic Response Unexpected With Drug Substitution, Thermal Burn, Thyroid Disorder, Thyroiditis, Tinnitus, Tonic Clonic Movements, Tooth Disorder, Tooth Fracture, Tooth Injury, Torticollis, Transfusion Reaction, Transient Tachypnoea of the Newborn, Transmission of Drug Via Semen, Transposition of the Great Vessels, Treatment Noncompliance, Tremor, Tremor Neonatal, Tricuspid Valve Disease, Tricuspid Valve Incompetence, Trisomy 13, Trisomy 21, Ultrasound Antenatal Screen Abnormal, Umbilical Cord Abnormality, Umbilical Cord Around Neck, Underweight, Unevaluable Event, Univentricular Heart, Unresponsive To Pain Stimuli, Unresponsive To Stimuli, Unstable Foetal Lie, Unwanted Pregnancy, Upper Limb Deformity, Upper Respiratory Tract Infection, Urinary Tract Disorder, Urinary Tract Infection, Urine Ketone Body Present, Urine Output Decreased, Uterine Contractions Abnormal, Uterine Contractions During Pregnancy, Uterine Cyst, Uterine Haemorrhage, Uterine Leiomyoma, Vaginal Disorder, Vaginal Haemorrhage, Vaginal Infection, Vaginitis Bacterial, Vascular Anomaly, Vasoconstriction, Ventricular Hypoplasia, Ventricular Septal Defect, Ventriculo-Peritoneal Shunt, Vertical Infection Transmission, Vertigo, Viral Infection, Vision Blurred, Visual Disturbance, Vocal Cord Disorder, Vocal Cord Paralysis, Vocal Cord Paresis, Vomiting, Vomiting In Pregnancy, Vomiting Neonatal, Walking Disability, Weight Decrease Neonatal, Weight Decreased, Weight Gain Poor, Weight Increased, Wound Infection, Wrong Technique In Drug Usage Process
| Definitions | |
| Abortion Spontaneous | Miscarriage means loss of an embryo or fetus before the 20th week of pregnancy. Most miscarriages occur during the first 14 weeks of pregnancy. The medical term for miscarriage is spontaneous abortion. |
| Anal Atresia | The anus is either not present or it is in the wrong place. |
| Anencephaly | Congenital absence of most of the brain and spinal cord. |
| Ankyloglossia Congenital | A congenital anomaly in which the mucous membrane under the tongue is too short limiting the mobility of the tongue. |
| Atrial Septal Defect | An atrial septal defect (ASD), a congenital defect, occurs when there is an opening in the atrial septum, or dividing wall between the two upper chambers of the heart, known as the right and left atria.Normally, oxygen-poor (blue) blood returns to the right atrium from the body, travels to the right ventricle, then is pumped into the lungs where it receives oxygen. Oxygen-rich (red) blood returns to the left atrium from the lungs, passes into the left ventricle, then is pumped out to the body through the aorta. An atrial septal defect allows oxygen-rich (red) blood to pass from the left atrium through the opening in the septum, and then mix with oxygen-poor (blue) blood in the right atrium. This heart defect can cause lung problems if not repaired. When blood passes through the ASD from the left atrium to the right atrium, a larger volume of blood than normal must be handled by the right side of the heart, causing the right side to become overworked and enlarged. Extra blood then passes through the pulmonary artery into the lungs, causing higher pressure than normal in the blood vessels in the lungs, a condition known as pulmonary hypertension. |
| Congenital | A physical abnormality that is present at birth. |
| Digeorge's Syndrome | DiGeorge syndrome (also called congenital thymic hypoplasia, or third and fourth pharyngeal pouch syndrome) is a birth defect that is caused by an abnormal chromosome and affects the baby's immune system. The syndrome is marked by absence or underdevelopment of the thymus and parathyroid glands. |
| DiGeorge syndrome is sometimes described as one of the "CATCH 22" disorders, so named because of their characteristics — cardiac defects, abnormal facial features, thymus underdevelopment, cleft palate, and hypocalcemia — caused by a deletion of several genes in chromosome 22. The specific facial features associated with DiGeorge syndrome include low-set ears, wide-set eyes, a small jaw, and a short groove in the upper lip. | |
| Dyspnoea | Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger. |
| Ebstein's Anomaly | Congenital downward displacement of the tricuspid valve into the right ventricle. |
| Ectopic Pregnancy | In an ectopic pregnancy, the fertilized egg implants in a location outside the uterus and tries to develop there. The word ectopic means "in an abnormal place or position." The most common site is the fallopian tube, the tube that normally carries eggs from the ovary to the uterus. However, ectopic pregnancy can also occur in the ovary, the abdomen, and the cervical canal (the opening from the uterus to the vaginal canal). The phrases tubal pregnancy, ovarian pregnancy, cervical pregnancy, and abdominal pregnancy refer to the specific area of an ectopic pregnancy. |
| Fallot's Tetralogy | A congenital malformation of the heart characterized by a defect in the ventricular septum, misplacement of the origin of the aorta, narrowing of the pulmonary artery, and enlargement of the right ventricle. |
| Hypoplastic Left Heart Syndrome | (Also known as HLHS), is a rare congenital heart defect in which the left side of the heart is severely underdeveloped. In babies with HLHS, the aorta and left ventricle are very small, and the aortic and mitral valves are either too small to allow sufficient blood flow or are atretic (closed) altogether. As blood returns from the lungs to the left atrium, it must pass through an atrial septal defect to the right side of the heart.In a healthy human, the left side of the heart receives oxygen-rich blood from the lungs and pumps it out to the rest of the body; with these structures underdeveloped, they cannot circulate blood to other organs, and the right ventricle must pump blood to both the lungs, as it would normally, and to the rest of the body, a situation which cannot be sustained for long. In cases of HLHS, the right side of the heart often must pump blood to the body through a patent ductus arteriosus. As the ductus arteriosus closes a few days after birth, blood flow is severely restricted and eventually cut off, leading to dangerously low circulation and eventually to shock. |
| Hypoplastic Right Heart Syndrome | (HRHS) refers to underdevelopment of the right sided structures of the heart. These defects cause inadequate blood flow to the lungs and thus, a blue or cyanotic infant. The major problem is pulmonary valve atresia (absence). This valve normally opens and closes to let blood flow to the pulmonary artery. Secondary problems include a very small (hypoplastic) right ventricle (lower chamber which normally pumps blood to the lungs); a small tricuspid valve (this valve allows blood to flow into the right ventricle) and a small (hypoplastic) pulmonary artery. Also, the blood flow into the coronary arteries may be abnormal causing damage to the heart muscle. |
| Neonatal Asphyxia | A condition in which an extreme decrease in the concentration of oxygen in the body accompanied by an increase in the concentration of carbon dioxide leads to loss of consciousness or death. |
| Neural Tube Defect | Any of various congenital defects of the brain and spinal cord, such as spina bifida, resulting from incomplete closing of the neural tube in an embryo. |
| Nystagmus | Rhythmic, oscillating motions of the eyes are called nystagmus. The to-and-fro motion is generally involuntary. Vertical nystagmus occurs much less frequently than horizontal nystagmus and is often, but not necessarily, a sign of serious brain damage. Nystagmus can be a normal physiological response or a result of a pathologic problem. ulation refers to a medical method of testing their connections to the brain, and therefore to the eyes. Cold or warm water flushed into the ear canal will generate motion signals from the inner ear. The eyes will respond to this signal with nystagmus if the pathways are intact. |
| Opisthotonus | A condition, caused by a tetanic spasm of the back muscles, in which the trunk is arched forward while the head and lower limbs are bent backward. |
| Persistent Foetal Circulation | The circulation of blood in the foetus is somewhat different from that of the baby after birth. This transition from foetal to neonatal circulation is one of the major physiologic changes after delivery. Before birth, the lungs are collapsed and the blood pressure in the lungs is quite high. This results in a very low blood flow through the lungs. After delivery, the lungs expand and the blood pressure in the lungs decreases. |
| In some babies, although the lungs expand the blood vessels in the lungs remain constricted resulting in persistently high blood pressure in the lungs. This reduces the amount of blood that the infant can pump through the lungs. This decreased blood flow through the lungs after birth is called persistent foetal circulation because it is a persistence of the pattern of blood flow normally seen prior to birth during the foetal period. | |
| Pulmonary Hypertension | From WebMD article:Babies whose mothers took antidepressant drugs in the second half of pregnancy are six times more likely to have a rare but dangerous lung ailment, a new study suggests. |
| One study isn't proof. But it's strong evidence that taking SSRI antidepressants -- such as Prozac, Zoloft, and Paxil -- carries an extra risk during pregnancy. | |
| The risk is that the babies will have PPHN: persistent pulmonary hypertension of the newborn. Only one or two in a thousand babies get this, but it's very serious. It kills about one in 10 babies who get it. In moderately severe cases, half the survivors suffer hearing loss or brain damage. | |
| Tardive Dyskinesia | Tardive dyskinesia is a mostly irreversible neurological disorder of involuntary movements caused by longterm use of antipsychotic or neuroleptic drugs. | When these drugs are used long term, tardive dyskinesia (TD) can result. About 20 percent of people taking antipsychotic drugs for more then one year become affected by TD. The prevalence of TD tends to be highest among elderly patients and among women. |
| Transposition of the Great Vessels | In transposition of the great arteries (TGA), the aorta and pulmonary artery are reversed. The aorta receives the oxygen-poor blood from the right ventricle, but it's carried back to the body without receiving more oxygen. Likewise, the pulmonary artery receives the oxygen-rich blood from the left ventricle but carries it back to the lungs. |
| Trisomy 13 | Patau syndrome, also called trisomy 13, is a congenital (present at birth) disorder associated with the presence of an extra copy of chromosome 13. The extra chromosome 13 causes numerous physical and mental abnormalities, especially heart defects. |
| Trisomy 21 | Down syndrome is the most common cause of mental retardation and malformation in a newborn. It occurs because of the presence of an extra chromosome. The extra chromosome in Down syndrome is labeled number 21. For this reason, the existence of three such chromosomes is sometimes referred to as Trisomy 21. |
| Ventricular Septal Defect | A ventricular septal defect is a hole in the wall of the heart (septum) that separates the left lower chamber (left ventricle) from the right lower chamber (right ventricle). The hole allows blood to flow from the left ventricle to the right ventricle instead of entering the aorta for distribution throughout the body. Ventricular septal defect is one of a group of heart problems found in newborn babies that are collectively called congenital heart disease. |
| Top 20 Adverse Reactions | |
| Adverse Reaction | Cases |
| Drug Exposure During Pregnancy | 346 |
| Caesarean Section | 56 |
| Neonatal Disorder | 39 |
| Abortion Spontaneous | 39 |
| Congenital Anomaly | 33 |
| Maternal Drugs Affecting Foetus | 30 |
| Premature Baby | 27 |
| Ventricular Septal Defect | 21 |
| Drug Withdrawal Syndrome Neonatal | 17 |
| Drug Exposure Via Breast Milk | 17 |
| Developmental Delay | 17 |
| Stillbirth | 15 |
| Irritability | 15 |
| Depression | 15 |
| Atrial Septal Defect | 14 |
| Vaginal Haemorrhage | 13 |
| Premature Labour | 12 |
| Convulsion | 12 |
| Complications of Maternal Exposure To Therapeutic Drugs | 12 |
| Tremor | 11 |
MedWatch is the Food and Drug Administration's program for reporting any undesirable experience associated with the use of a medical product. If you think you or someone in your family has experienced an adverse reaction from taking Sertraline and it has not been reported to the FDA, see this page for instructions on reporting the adverse event through your doctor or directly to the FDA using an online form.
A May 2006 USA Today article states that "drug companies are required to file any reports they have to the FDA, but consumers and doctors report such events on a voluntary basis. Studies suggest the FDA's Adverse Events Reporting System database captures only 1% to 10% of drug-induced side effects and deaths, "maybe even less than 1%," says clinical pharmacologist Alastair J.J. Wood, an associate dean at Vanderbilt Medical School in Nashville. So the real number of cases is almost certainly much higher".