Psychiatric Drug Adverse Reactions

The tables below are comprised of adverse reactions to psychiatric drugs that have been reported to the FDA's Adverse Event Reporting System (Medwatch) between 2004 and 2006. The table below is comprised only of the drugs that were reported as the Primary Suspect Drug (the drug suspected of causing the adverse reaction in the patient). It does not include those instances where multipe drugs were reported as causing the adverse reaction. It is important to keep in mind that by the FDA's own admission, only 1-10% of side effects to prescription drugs are ever reported to the FDA, so the numbers/tables below are low in comparison to the actual side effects occuring in the general population.

All of the adverse reactions reported for these psychiatric drugs have not been included on this combined drugs table because of table size/download time considerations; there are simply too many of them. You can select a specific psychiatric drug from the Name Your Drug menu to see a full list of the adverse reactions reported for that drug.

The Rpt'd By column lists the occupation of the individual who reported the drug reaction using these abbreviations: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other Healthcare Provider, PH-Pharmacist. Where the Rpt'd By or Indications field is blank, that information was not present in the FDA report.




Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
0 Days Unk 3185282 4319821 01/01/97 03/19/04 Tegretol X CN Congenital Oesophageal Anomaly, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus
0 Months M 3464790 4335650 04/14/00 04/06/04 Effexor X X X MD Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus
0 Days F 3911686 4515192 01/07/03 12/01/04 Deroxat X X X CN Congenital Ventricular Septal Defect, Drug Exposure During Pregnancy, Heart Disease Congenital
0 Days M 3967126 4382202 06/15/04 Zoloft X X MD Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Neonatal Disorder, Neonatal Tachypnoea
0 Days F 4048691 4266284 10/22/03 01/06/04 Atarax MD Premature Baby Hypertonia Neonatal, Hypotonia Neonatal, Maternal Drugs Affecting Foetus, Tremor Neonatal
0 Days M 4074663 4443542 10/01/03 09/01/04 Celexa X X X MD Depression Drug Exposure During Pregnancy
0 Days M 4078744 4279165 01/22/04 Paroxetine X X X OT Accidental Exposure Congenital Hyperextension of Spine, Convulsion Neonatal, Hypotonia Neonatal, Intraventricular Haemorrhage Neonatal, Lethargy, Maternal Drugs Affecting Foetus, Neonatal Apnoeic Attack, Neonatal Disorder, Nervous System Disorder
0 Days M 4088957 4288525 01/03/04 02/05/04 Fluoxetine X X OT Drug Exposure During Pregnancy
0 Days 4092070 4293376 02/10/04 Celexa X X X MD Depression Maternal Drugs Affecting Foetus, Multiple Congenital Abnormalities
0 Days 4103762 4309146 02/03/04 03/01/04 Lexapro X X X MD Depression Maternal Drugs Affecting Foetus, Multiple Congenital Abnormalities
0 Days F 4103762 4316967 02/03/04 03/12/04 Lexapro X X X MD Depression Congenital Anomaly, Congenital Musculoskeletal Anomaly, Maternal Drugs Affecting Foetus
0 Days M 4121636 4334526 11/20/03 04/07/04 Lamictal X X CN Epilepsy Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
0 Days M 4134792 4507351 11/18/04 Celexa X X X MD Depression Congenital Anomaly of Inner Ear, Congenital Atrial Septal Defect, Congenital Cardiovascular Anomaly, Congenital Elevation of Scapula, Congenital Torticollis, Deafness Congenital, Drug Exposure During Pregnancy
0 Days M 4145779 4360946 05/17/04 Zoloft X X MD Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Disorder, Tardive Dyskinesia
0 Months M 4148303 4369719 01/01/03 05/28/04 Effexor XR X X X OT Depression Drug Exposure During Pregnancy
0 Days F 4148585 4386273 03/25/04 06/22/04 Cipramil X X X Agitation Neonatal, Drug Exposure During Pregnancy, Feeling Jittery, Hypotonia Neonatal, Irritability, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Tremor Neonatal
0 Days F 4167471 4390569 04/27/04 06/30/04 04/27/04 Lexapro X X X CN Depression Atelectasis, Death Neonatal, Drug Exposure During Pregnancy, Dyspnoea, Neonatal Disorder, Neonatal Respiratory Arrest, Neonatal Tachycardia, Sudden Death
0 Days F 4167471 4488279 04/27/04 10/26/04 04/27/04 Lexapro X X X MD Depression Atelectasis Neonatal, Cyanosis Neonatal, Death Neonatal, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Respiratory Arrest, Neonatal Tachycardia, Respiratory Disorder Neonatal, Sudden Death
0 Days M 4169759 4395280 09/02/91 07/06/04 Depakene X CN Congenital Hand Malformation, Drug Exposure During Pregnancy, Hypotonia, Psychotic Disorder, Visual Disturbance
0 Months M 4188546 4415335 06/15/04 07/30/04 Effexor XR X X X Depression Cardiac Arrest Neonatal, Drug Exposure During Pregnancy, Neonatal Tachycardia
0 Days M 4192294 4422991 06/15/04 08/05/04 Provigil MD Sedation Drug Exposure During Pregnancy
0 Days F 4211025 4446922 07/26/04 09/08/04 Citalopram HBr X X X Depression Congenital Ventricular Septal Defect, Drug Exposure During Pregnancy
0 Days M 4222980 4511901 05/17/04 11/23/04 Celexa X X X MD Depression Drug Exposure During Pregnancy, Foetal Growth Retardation, Jaundice Neonatal, Neonatal Disorder
0 Days 4223722 4465283 07/16/04 09/29/04 Remeron X X X MD Congenital Ectopic Bladder, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
0 Days M 4223722 4467378 07/16/04 10/04/04 Remeron X X X MD Congenital Anomaly, Congenital Ectopic Bladder, Congenital Spinal Cord Anomaly, Drug Exposure During Pregnancy, Gastrointestinal Disorder Congenital
0 Days F 5651082 4483783 10/25/04 Valproate Sodium X Drug Exposure During Pregnancy, Strabismus Congenital
0 Days F 5651082 4492590 11/04/04 Valproate Sodium X Drug Exposure During Pregnancy
0 Days F 5651082 4493813 11/05/04 Valproate Sodium X Drug Exposure During Pregnancy
0 Days M 5651083 4483786 10/25/04 Valproate Sodium X Drug Exposure During Pregnancy, Strabismus Congenital
0 Days M 5651083 4492585 11/04/04 Valproate Sodium X Congenital Eye Disorder, Drug Exposure During Pregnancy
0 Days M 5651083 4493812 11/05/04 Valproate Sodium X Drug Exposure During Pregnancy
0 Days M 5651084 4483787 10/25/04 Valproate Sodium X Congenital Joint Malformation, Drug Exposure During Pregnancy, Hypotonia, Memory Impairment
0 Days M 5651084 4492594 11/04/04 Valproate Sodium X Congenital Joint Malformation, Drug Exposure During Pregnancy, Hypotonia, Memory Impairment, Movement Disorder, Strabismus Congenital
0 Days M 5651084 4493810 11/05/04 Valproate Sodium X Congenital Joint Malformation, Drug Exposure During Pregnancy, Hypotonia, Memory Impairment, Movement Disorder
0 Days F 5654186 4479970 08/10/04 10/18/04 Lorazepam Drug Exposure During Pregnancy, Neonatal Apnoeic Attack
0 Days F 5658869 4577015 10/06/04 02/08/05 Celexa X X X Anxiety, Depression Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
0 Days M 5660326 4495050 01/01/89 11/08/04 Valproic Acid X Drug Exposure During Pregnancy Congenital Hand Malformation, Congenital Hearing Disorder, Disturbance In Attention, Drug Exposure During Pregnancy, Dyspnoea, Foetal Valproate Syndrome, Speech Disorder
0 Days 5660353 4495078 11/08/04 Depakene X Drug Exposure During Pregnancy Congenital Anomaly, Drug Exposure During Pregnancy, Mental Disorder
0 Days F 5667622 4471541 01/01/04 10/12/04 Depakene X Drug Exposure During Pregnancy Bradycardia, Congenital Atrial Septal Defect, Drug Exposure During Pregnancy, Foetal Arrhythmia, Heart Disease Congenital, Neonatal Respiratory Distress Syndrome
0 Days M 5667865 4471956 12/01/03 10/07/04 Citalopram X X X OT Panic Disorder Jaundice Neonatal, Neonatal Disorder
0 Days F 5693690 4518949 12/01/04 Neurontin MD Ill-Defined Disorder Congenital Ventricular Septal Defect, Drug Exposure During Pregnancy
0 Days F 5695491 4522878 09/11/04 12/08/04 Cipralex X X X OT Congenital Hip Deformity, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertension Neonatal, Hypertonia Neonatal, Irritability, Neonatal Disorder, Nervousness, Screaming, Tremor Neonatal
0 Days F 5709787 4540735 12/22/04 Fluoxetine X X Congenital Eye Disorder, Drug Exposure During Pregnancy
0 Days M 5710155 4541905 09/20/04 12/27/04 Citalopram HBr X X X PH Drug Exposure During Pregnancy, Heart Disease Congenital
0 Months M 5727835 4562723 08/01/04 01/21/05 Zyprexa MD Drug Exposure During Pregnancy, Hypotonia Neonatal
0 Days M 5729122 4569409 01/11/05 02/03/05 Ludiomil X X X MD Somnolence
0 Days 5729245 4569617 01/01/02 02/03/05 Depakene X Drug Exposure During Pregnancy Thrombocytopenia Neonatal
0 Days 5731094 4565915 01/28/05 Citalopram HBr X X X PH Depression Camptodactyly Congenital, Congenital Anomaly, Congenital Hand Malformation, Congenital Pulmonary Hypertension, Drug Exposure During Pregnancy, Foetal Movements Decreased
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
0 Days 5734316 4576298 02/09/05 Valproate Sodium X Foetal Valproate Syndrome
0 Days 5734317 4576300 02/09/05 Valproate Sodium X Foetal Valproate Syndrome
0 Days 5734319 4576302 02/09/05 Valproate Sodium X Foetal Valproate Syndrome
0 Days 5734320 4576303 02/09/05 Valproate Sodium X Foetal Valproate Syndrome
0 Days 5734321 4576305 02/09/05 Valproate Sodium X Foetal Valproate Syndrome
0 Days 5734322 4576306 02/09/05 Valproate Sodium X Foetal Valproate Syndrome
0 Days 5734323 4576307 02/09/05 Valproate Sodium X Foetal Valproate Syndrome
0 Days F 5743239 4577464 02/08/05 Atarax OT Ill-Defined Disorder Cardiomyopathy Neonatal, Congenital Pyelocaliectasis, Drug Exposure During Pregnancy, Neonatal Disorder, Neonatal Hypoxia, Neonatal Respiratory Distress Syndrome
0 Days F 5743490 4588649 01/24/05 02/22/05 Clozaril X Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Respiratory Distress Syndrome, Somnolence Neonatal, Vomiting Neonatal
0 Days 5748664 4587974 02/15/05 Valproate Sodium X MD Drug Exposure During Pregnancy, Foetal Valproate Syndrome
0 Days 5748667 4587975 02/15/05 Valproate Sodium X MD Drug Exposure During Pregnancy, Foetal Valproate Syndrome
0 Days 5748674 4587976 02/15/05 Valproate Sodium X MD Drug Exposure During Pregnancy, Foetal Valproate Syndrome
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
0 Days M 5749240 4594767 01/02/05 03/01/05 Ludiomil X X X Drug Exposure During Pregnancy
0 Days 5750184 4589481 02/16/05 Valproate Sodium X OT Drug Exposure During Pregnancy, Foetal Valproate Syndrome
0 Days 5755143 4596464 02/28/05 Citalopram X X X MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
0 Days 5755958 4596445 02/28/05 Citalopram X X X MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
0 Days 5755967 4596449 02/28/05 Citalopram X X X MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
0 Days 5755974 4596453 02/28/05 Citalopram X X X MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
0 Days 5755977 4596456 02/28/05 Citalopram X X X MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
0 Days M 5762003 4613462 03/21/05 Epilim X Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Foetal Valproate Syndrome
0 Days F 5762005 4613463 03/21/05 Valproic Acid X Drug Exposure During Pregnancy Neonatal Neuroblastoma
0 Days F 5762005 4617378 03/23/05 Valproic Acid X Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Neonatal Neuroblastoma
0 Days M 5764654 4617252 03/23/05 Epilim X Drug Exposure During Pregnancy Congenital Anomaly, Drug Exposure During Pregnancy, Foetal Valproate Syndrome
0 Days M 5764655 4617253 03/23/05 Epilim X Drug Exposure During Pregnancy Congenital Anomaly, Drug Exposure During Pregnancy, Foetal Valproate Syndrome
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
0 Days F 5765972 4619726 03/25/05 Epilim X Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Foetal Valproate Syndrome
0 Days M 5778907 4640661 04/20/05 Valproate Sodium X Anxiety, Autism, Congenital Nose Malformation, Congenital Oral Malformation, Foetal Valproate Syndrome, Social Avoidant Behaviour, Speech Disorder
0 Days Unk 5785616 4648686 05/27/97 04/29/05 12/30/97 Tegretol X Drug Exposure During Pregnancy, Sudden Death
0 Days M 5798380 4659271 01/23/04 05/10/05 Citalopram HBr X X X OT Drug Exposure During Pregnancy
0 Days M 5798749 4659576 01/27/05 05/10/05 Serax Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal, Jaundice Neonatal, Poor Weight Gain Neonatal, Suicide Attempt, Tremor Neonatal
0 Days M 5800139 4661119 01/12/04 05/11/05 Citalopram HBr X X X OT Congenital Central Nervous System Anomaly, Congenital Eye Disorder, Drug Exposure During Pregnancy, Haemangioma Congenital
0 Months 5809874 4674377 03/04/05 05/24/05 Effexor XR X X X OT Convulsion Neonatal, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Nervous System Disorder
0 Days F 5823191 4698332 06/21/05 Neurontin MD Abortion Induced, Congenital Jaw Malformation, Congenital Nose Malformation, Drug Exposure During Pregnancy, Foetal Malformation
0 Days F 5828655 4703954 06/30/05 Valproate Sodium X Congenital Arterial Malformation, Congenital Oral Malformation, Foetal Valproate Syndrome
0 Days F 5829568 4698486 01/01/03 06/22/05 Zoloft X X Drug Exposure During Pregnancy, Neonatal Aspiration
0 Days M 5848199 4728743 07/29/05 Lamictal X X CN Bipolar Disorder Congenital Foot Malformation, Drug Exposure During Pregnancy
0 Days 5874453 4763662 08/25/05 09/08/05 Tofranil X X MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
0 Days M 5874453 4785977 08/25/05 10/03/05 Tofranil X X MD Congenital Limb Hyperextension, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypertonia Neonatal, Irritability, Neonatal Disorder, Restlessness, Tremor
0 Days M 5874453 4791296 08/25/05 10/07/05 Tofranil X X MD Congenital Limb Hyperextension, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypertonia Neonatal, Irritability, Restlessness, Tremor
0 Days M 5894585 4792517 09/27/05 10/10/05 Clozaril X MD Drug Exposure During Pregnancy, Tachycardia Foetal
0 Days M 5894585 4828602 09/27/05 11/15/05 Clozaril X MD Drug Exposure During Pregnancy, Tachycardia Foetal
0 Days M 5898843 4797298 06/16/05 10/13/05 Seroxat X X X CN Drug Use for Unknown Indication Congenital Anomaly, Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Eating Disorder, Feeding Disorder Neonatal, Muscle Twitching
0 Days F 5907496 4807802 10/24/05 Valproate Sodium X Congenital Anomaly, Drug Exposure During Pregnancy, Foetal Valproate Syndrome
0 Days M 5924713 4830662 11/17/05 Valproate Sodium X Congenital Anomaly, Congenital Nose Malformation, Congenital Oral Malformation, Congenital Visual Acuity Reduced, Foetal Valproate Syndrome, Hypotonia, Obsessive-Compulsive Disorder, Psychomotor Hyperactivity
0 Days M 5925691 4832263 11/19/05 Valproate Sodium X Abnormal Behaviour, Autism, Congenital Anomaly, Dacryostenosis Congenital, Foetal Valproate Syndrome, Hypotonia, Visual Acuity Reduced
0 Days M 5925691 4849079 12/09/05 Valproate Sodium X Abnormal Behaviour, Autism, Congenital Anomaly, Coordination Abnormal, Dacryostenosis Congenital, Foetal Valproate Syndrome, Hypotonia, Visual Acuity Reduced
0 Days M 5925691 4865639 12/23/05 Epilim X Drug Exposure During Pregnancy Abnormal Behaviour, Autism, Congenital Anomaly, Congenital Infection, Coordination Abnormal, Dacryostenosis Congenital, Foetal Valproate Syndrome, Hypotonia, Visual Acuity Reduced
0 Days 5942578 4855667 01/01/05 12/16/05 Ergenyl Chrono X Drug Exposure During Pregnancy Congenital Hydrocephalus, Stillbirth
0 Days M 5952395 4868068 01/01/85 12/29/05 01/01/85 Epilim X Drug Exposure During Pregnancy Abdominal Distension, Congenital Cystic Kidney Disease, Congenital Genitourinary Abnormality, Foetal Valproate Syndrome
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
0 Days F 5954654 4871648 08/25/05 01/04/06 Luvox X X MD Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia, Irritability, Pyrexia, Somnolence, Tremor
0 Days F 5954654 4896619 08/25/05 01/31/06 Luvox X X MD Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal, Hypotonia, Irritability, Pyrexia, Somnolence, Tremor
0 Days F 5954654 4909025 08/25/05 02/13/06 Luvox X X MD Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal, Fever Neonatal, Hypotonia Neonatal, Irritability, Somnolence Neonatal, Tremor Neonatal
0 Days F 5955277 4872674 02/04/05 01/05/06 Luvox X X MD Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal
0 Days F 5955277 4896618 02/04/05 01/31/06 Luvox X X MD Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal, Hypotonia, Tremor
0 Days F 5957835 4876600 02/04/05 01/10/06 Myslee OT Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia, Neonatal Disorder, Tremor
0 Days F 5957835 4892671 02/04/05 01/26/06 Myslee OT Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia, Neonatal Disorder, Tremor
0 Days F 5957835 4908891 02/04/05 02/10/06 Myslee OT Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia, Respiratory Disorder Neonatal, Tremor
0 Days F 5957835 4947159 02/04/05 03/17/06 Myslee OT Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia, Hypotonia Neonatal, Neonatal Tachypnoea, Tremor
0 Days 5962817 4883663 01/18/06 Ambien CN Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy
0 Days F 5963279 4916488 11/25/05 02/20/06 Luvox X X MD Drug Exposure During Pregnancy Agitation Neonatal, Anxiety, Drug Withdrawal Syndrome Neonatal, Tremor Neonatal, Vomiting Neonatal
0 Days F 5978146 4902709 08/25/05 02/07/06 Seroquel X X X MD Schizophrenia Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal, Irritability, Somnolence Neonatal, Syncope
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
0 Days F 5978146 4916657 08/25/05 02/20/06 Seroquel X X X OT Schizophrenia Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
0 Days M 5993279 4925301 02/16/06 02/28/06 Paxil X X X MD Neonatal Asphyxia
0 Days M 5993279 4938309 02/16/06 03/09/06 Paxil X X X MD Drug Exposure During Pregnancy, Neonatal Asphyxia
0 Days M 5993279 4947797 02/16/06 03/20/06 Paxil X X X MD Drug Exposure During Pregnancy, Neonatal Asphyxia
0 Days M 5993279 4950489 02/16/06 03/22/06 Paxil X X X MD Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus, Neonatal Asphyxia
0 Days M 5993279 5123846 02/16/06 10/10/06 Paxil X X X MD Drug Exposure During Pregnancy, Neonatal Asphyxia
0 Days 6017795 4960968 04/03/06 Ambien CN Drug Use for Unknown Indication Drug Exposure During Pregnancy
0 Days M 6031671 4981810 12/19/04 04/25/06 Paxil X X X MD Depression Drug Exposure During Pregnancy, Neonatal Asphyxia
0 Days M 6031671 5013626 12/19/04 05/30/06 Paxil X X X MD Bipolar Disorder Drug Exposure During Pregnancy, Neonatal Asphyxia, Respiratory Disorder Neonatal, Somnolence Neonatal
0 Days F 6081820 5050594 06/05/06 07/13/06 Paroxetine HCL X X X CN Drug Exposure During Pregnancy
0 Hours F 6088186 5058476 07/21/06 04/14/03 Catapres MD Essential Hypertension Drug Exposure During Pregnancy
0 Days F 6182153 5168544 12/08/06 Depakene X OT Drug Exposure During Pregnancy Congenital Central Nervous System Anomaly, Congenital Hydrocephalus
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Hours M 4101662 4312455 02/01/04 03/05/04 Valium CN Maternal Drugs Affecting Foetus, Neonatal Apnoeic Attack
1 Hours F 4193883 4426931 01/01/01 08/11/04 Effexor X X X MD Depression Drug Exposure During Pregnancy, Myoclonus, Neonatal Apnoeic Attack, Neonatal Disorder
1 Hours F 4193883 4432424 01/01/01 08/20/04 Effexor X X X MD Depression Congenital Mitral Valve Incompetence, Congenital Ventricular Septal Defect, Cyanosis Neonatal, Drug Exposure During Pregnancy, Heart Rate Increased, Hypotonia Neonatal, Myoclonus, Neonatal Apnoeic Attack, Subarachnoid Haemorrhage Neonatal
1 Hours F 4193883 4434322 08/25/04 Effexor X X X MD Depression Congenital Mitral Valve Incompetence, Congenital Ventricular Septal Defect, Drug Exposure During Pregnancy, Heart Rate Increased, Hypotonia Neonatal, Myoclonus, Neonatal Apnoeic Attack, Neonatal Disorder, Subarachnoid Haemorrhage Neonatal
1 Hours M 5903945 4796746 10/07/05 Paroxetine HCL X X X MD Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Foetal Distress Syndrome, Hypertonia Neonatal, Pyrexia
1 Hours 6059270 5019314 02/10/06 06/06/06 03/15/06 Rivotril CN Anxiety Drug Exposure During Pregnancy
1 Hours 6087989 5058088 06/12/06 07/21/06 Valium CN Drug Use for Unknown Indication Anaemia Neonatal, Drug Exposure During Pregnancy, Hypotonia, Neonatal Disorder
1 Hours F 6125469 5093458 08/28/06 Citalopram HBr X X X Agitation Neonatal, Bradycardia Neonatal, Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Neonatal Asphyxia
1 Hours F 6125469 5107777 09/14/06 Citalopram HBr X X X Agitation Neonatal, Bradycardia Neonatal, Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Neonatal Asphyxia, Neonatal Disorder
1 Hours F 6155009 5136244 10/17/06 10/27/06 Rivotril MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Neonatal Respiratory Arrest
1 Hours F 6155009 5140155 10/17/06 10/31/06 Rivotril MD Drug Use for Unknown Indication Drug Exposure During Pregnancy, Neonatal Respiratory Arrest
1 Hours F 6155009 5144215 10/17/06 11/06/06 Rivotril MD Borderline Personality Disorder Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
2 Hours M 4087961 4318050 01/31/04 03/17/04 Tegretol X MD Bradycardia Neonatal, Drug Exposure During Pregnancy, Hypotonia, Hypotonia Neonatal, Neonatal Disorder
2 Hours M 4087961 4553070 01/31/04 01/14/05 Tegretol X MD Bradycardia Neonatal, Drug Exposure During Pregnancy, Hypotonia, Hypotonia Neonatal, Neonatal Disorder
2 Hours F 6141339 5120451 09/18/06 10/04/06 Seroquel X X X PH Agitation Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy
2 Hours F 6141339 5134679 09/18/06 10/25/06 Seroquel X X X PH Agitation Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy, Nervousness
0 Days F 6000593 4981102 07/30/05 04/18/06 Prozac X X OT Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Maternal Condition Affecting Foetus, Neonatal Respiratory Distress Syndrome
6 Hours F 6026803 4964881 04/03/06 Fluoxetine X X Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Feeling Jittery, Fever Neonatal, Hypertonia Neonatal, Vomiting, Vomiting Neonatal
6 Hours F 6051627 5002322 05/12/06 Fluoxetine X X MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypertonia Neonatal, Vomiting Neonatal
6 Hours F 6133459 5103026 09/08/06 Fluoxetine X X Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Feeling Jittery, Hypertonia Neonatal, Neonatal Disorder, Vomiting Neonatal
10 Hours F 6051628 5002327 12/20/05 05/12/06 12/20/05 Fluoxetine HCL X X MD Depression Drug Exposure During Pregnancy, Haemorrhage
10 Hours F 6051628 5053858 12/20/05 07/12/06 12/20/05 Fluoxetine HCL X X MD Depression Drug Exposure During Pregnancy, Haemorrhage, Malaise
12 Hours F 4004986 4333207 04/02/04 Effexor X X X Depression Drug Exposure During Pregnancy, Neonatal Disorder, Sedation
12 Hours F 4166129 4388841 06/24/04 Paroxetine X X X CN Bradycardia Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
12 Hours M 4193369 4429502 08/19/04 Valium CN Drug Exposure During Pregnancy, Foetal Growth Retardation, Neonatal Diabetes Mellitus
12 Hours F 5940816 4846033 11/30/05 Paroxetine HCL X X X Depression Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Toxicity, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Hypertonia Neonatal, Neonatal Respiratory Distress Syndrome, Psychomotor Hyperactivity, Pyrexia, Serotonin Syndrome, Tremor
12 Hours F 5940816 4847459 12/05/05 Paroxetine HCL X X X Depression Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Toxicity, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Feeling Jittery, Fever Neonatal, Hypertonia, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Psychomotor Hyperactivity, Serotonin Syndrome, Tremor Neonatal
1 Day 3783841 5088962 08/30/96 08/22/06 09/09/96 Prozac X X MD Bradycardia Neonatal, Congenital Tricuspid Valve Atresia, Cyanosis Neonatal, Drug Exposure During Pregnancy, Heart Disease Congenital, Hypertension Neonatal, Neonatal Disorder, Neonatal Hypotension, Oedema Neonatal
1 Day F 3783841 5113814 01/24/96 09/20/06 09/09/96 Prozac X X MD Drug Use for Unknown Indication Bradycardia Neonatal, Congenital Tricuspid Valve Atresia, Drug Exposure During Pregnancy, Heart Disease Congenital, Malaise, Maternal Condition Affecting Foetus, Neonatal Disorder, Neonatal Hypotension
1 Day M 3831555 4426880 04/04/02 08/11/04 Atarax OT Anxiety Congenital Atrial Septal Defect, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Grand Mal Convulsion, Hypotonia Neonatal
1 Day M 3831555 4733610 01/01/02 07/29/05 Atarax OT Anxiety, Condition Aggravated Congenital Heart Valve Disorder, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Grand Mal Convulsion, Hypotonia Neonatal, Neonatal Disorder
1 Day M 3831555 4822938 01/01/02 11/04/05 Atarax OT Anxiety, Condition Aggravated Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Grand Mal Convulsion, Hypotonia Neonatal
1 Day 3932072 4385678 03/03/03 06/23/04 Zyprexa MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dystonia, Neonatal Disorder, Tremor
1 Day F 4005815 4344330 08/19/03 04/19/04 Xanax OT Cardio-Respiratory Arrest Neonatal, Drug Exposure During Pregnancy, Foetal Arrhythmia, Somnolence Neonatal
1 Day F 4028078 4319373 09/18/95 03/03/04 Valproate Sodium X Congenital Anomaly, Dyskinesia, Foetal Valproate Syndrome, Hypertonia, Maternal Drugs Affecting Foetus, Muscle Twitching
1 Day F 4028078 4335843 09/18/95 04/05/04 Valproate Sodium X CN Congenital Nose Malformation, Drug Toxicity, Dyskinesia, Foetal Valproate Syndrome, Hypertonia, Maternal Drugs Affecting Foetus, Muscle Twitching
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day F 4040106 4294495 01/06/04 02/11/04 Zyprexa MD Anomaly of External Ear Congenital, Maternal Drugs Affecting Foetus
1 Day M 4054840 4300562 11/10/03 02/18/04 11/10/03 Zyprexa MD Maternal Drugs Affecting Foetus
1 Day M 4064368 4264642 12/06/03 01/02/04 Alprazolam Panic Disorder Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypersensitivity, Hypotonia, Irritability, Muscle Twitching, Neonatal Apnoeic Attack
1 Day M 4064368 4288543 12/06/03 02/05/04 Alprazolam Panic Disorder Drug Toxicity, Drug Withdrawal Syndrome, Heart Rate Increased, Hypersensitivity, Hypotonia, Hypotonia Neonatal, Irritability, Maternal Drugs Affecting Foetus, Muscle Twitching, Neonatal Apnoeic Attack
1 Day M 4072963 4273868 05/25/02 01/15/04 Prozac X X Blood Pressure Increased, Cognitive Disorder, Difficulty In Walking, Maternal Drugs Affecting Foetus, Neonatal Disorder, Neonatal Respiratory Arrest
1 Day F 4077876 4277696 09/21/03 01/21/04 Prozac X X MD Congenital Foot Malformation, Congenital Hand Malformation, Maternal Drugs Affecting Foetus
1 Day M 4088998 4288704 02/17/96 02/05/04 Depakene X Drug Exposure During Pregnancy Foetal Valproate Syndrome, Maternal Drugs Affecting Foetus, Nervous System Disorder
1 Day M 4089256 4315330 10/25/03 03/09/04 Zyprexa MD Maternal Drugs Affecting Foetus
1 Day M 4089898 4288540 12/05/03 02/05/04 Ativan CN Convulsion Neonatal, Foetal Distress Syndrome, Hypersensitivity, Maternal Drugs Affecting Foetus, Muscle Rigidity, Neonatal Disorder
1 Day M 4090196 4289373 12/05/03 02/06/04 Ativan CN Accidental Exposure Convulsion, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Hypersensitivity, Muscle Rigidity
1 Day F 4091165 4289241 12/29/03 02/06/04 Atarax MD Anxiety Hypotonia Neonatal, Maternal Drugs Affecting Foetus, Neonatal Respiratory Distress Syndrome, Somnolence Neonatal
1 Day F 4091165 4475195 12/29/03 10/12/04 Atarax MD Anxiety Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Somnolence
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day F 4092347 4294349 10/16/03 02/11/04 Zyprexa OT Maternal Drugs Affecting Foetus
1 Day M 4094998 4300168 12/18/03 02/18/04 Strattera X X Maternal Drugs Affecting Foetus, Neonatal Disorder, Pain
1 Day M 4094998 4356767 12/18/03 05/07/04 Strattera X X MD Intraventricular Haemorrhage Neonatal, Maternal Drugs Affecting Foetus, Pain
1 Day M 4098434 4301117 01/07/04 02/18/04 Stilnox OT Hypoglycaemia, Maternal Drugs Affecting Foetus, Renal Failure
1 Day M 4098434 4330741 01/07/04 03/31/04 Stilnox Cardiac Failure, Foetal Heart Rate Deceleration, Hypoglycaemia, Hyponatraemia, Maternal Drugs Affecting Foetus, Neonatal Disorder, Renal Failure
1 Day M 4102199 4307046 10/09/96 02/25/04 Prozac X X MD Congenital Anomaly, Maternal Drugs Affecting Foetus
1 Day M 4102242 4307140 02/25/04 Prozac X X MD Congenital Anomaly, Congenital Bladder Anomaly, Maternal Drugs Affecting Foetus
1 Day M 4107597 4314580 03/08/04 Elavil X X X Hernia Congenital, Maternal Drugs Affecting Foetus
1 Day F 4108079 4317958 02/07/04 03/16/04 Paroxetine HCL X X X CN Depression, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
1 Day F 4108079 4335698 02/07/04 04/09/04 Paroxetine HCL X X X CN Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
1 Day F 4108079 4352734 02/06/04 05/04/04 Paroxetine HCL X X X CN Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypoglycaemia, Hypoglycaemia Neonatal, Nausea, Neonatal Disorder, Tremor, Tremor Neonatal
1 Day F 4108079 4357040 02/06/04 05/12/04 Paroxetine HCL X X X CN Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypoglycaemia, Nausea, Tremor
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day Unk 4112634 4319368 01/01/93 03/16/04 Depakene X Grand Mal Convulsion Autism, Congenital Anomaly, Congenital Foot Malformation, Foetal Valproate Syndrome, Maternal Drugs Affecting Foetus
1 Day F 4112898 4319229 01/27/94 03/16/04 Epilim X CN Congenital Anomaly, Congenital Atrial Septal Defect, Congenital Nose Malformation, Congenital Ventricular Septal Defect, Dyspnoea, Foetal Distress Syndrome, Foetal Valproate Syndrome, Haemangioma Congenital, Hypotonia, Maternal Drugs Affecting Foetus, Memory Impairment, Speech Disorder
24 Hours 4118089 4330140 04/02/04 Tegretol X Agitation Neonatal, Drug Exposure During Pregnancy, Irritability
1 Day M 4122444 4332174 01/08/04 03/31/04 Prozac X X OT Maternal Drugs Affecting Foetus
1 Day M 4123743 4333000 12/04/03 03/30/04 Depakine Chrono X CN Maternal Drugs Affecting Foetus, Weight Decrease Neonatal
1 Day M 4123743 4344434 12/04/03 04/19/04 Depakine Chrono X CN Drug Exposure During Pregnancy Hypotonia Neonatal, Maternal Drugs Affecting Foetus, Weight Decreased
1 Day M 4123743 4421238 12/01/03 08/04/04 Valproate Sodium X CN Congenital Anomaly, Drug Exposure During Pregnancy, Hypotonia Neonatal, Weight Decrease Neonatal
1 Day F 4127847 4338323 10/14/03 04/07/04 Xanax MD Depression Agitation, Drug Exposure During Pregnancy, Hypertonia, Hypotonia, Irritability, Neonatal Disorder, Nervous System Disorder, Sedation
1 Day M 4128664 4339865 10/28/87 04/12/04 Valproate Sodium X CN Abnormal Behaviour, Congenital Jaw Malformation, Congenital Nose Malformation, Foetal Valproate Syndrome, Irritability, Maternal Drugs Affecting Foetus, Sleep Disorder
1 Day F 4131734 4344334 06/17/03 04/19/04 Xanax OT Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Growth Retardation, Hypertonia Neonatal, Neonatal Disorder, Tremor Neonatal
1 Day M 4133746 4351442 07/30/03 05/03/04 02/04/04 Tegretol X Akinesia, Congenital Eyelid Malformation, Drug Exposure During Pregnancy, Dysphagia, Hypotonia Neonatal
1 Day M 4133746 4465035 07/30/03 10/04/04 02/04/04 Tegretol X Akinesia, Drug Exposure During Pregnancy, Dysphagia, Hypotonia Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day M 4135868 4350168 03/14/04 04/26/04 Zoloft X X MD Depression Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus
1 Day M 4136463 4350879 04/27/04 Depakene X OT Maternal Drugs Affecting Foetus, Neonatal Respiratory Distress Syndrome
1 Day M 4136463 4423940 08/05/04 Depakine X Abnormal Behaviour, Autism, Drug Exposure During Pregnancy, Mental Disorder
1 Day M 4137693 4352358 03/14/04 04/28/04 Risperdal MD Complications of Maternal Exposure To Therapeutic Drugs, Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus
1 Day M 4137693 4372427 03/14/04 05/26/04 Risperdal MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyskinesia Neonatal, Irritability, Respiratory Disorder Neonatal, Tremor
1 Day F 4139845 4345721 12/08/98 04/21/04 Depakene X Camptodactyly Congenital, Congenital Anomaly, Congenital Atrial Septal Defect, Congenital Cyst, Congenital Eyelid Malformation, Congenital Genital Malformation, Congenital Jaw Malformation, Congenital Nose Malformation, Congenital Oral Malformation, Congenital Ventricular Septal Defect, Foetal Growth Retardation, Hypotonia Neonatal, Maternal Drugs Affecting Foetus, Neonatal Disorder
1 Day F 4141846 4348237 09/19/04 04/22/04 Prozac X X MD Bradycardia Neonatal, Maternal Drugs Affecting Foetus
1 Day M 4147943 4364814 01/13/04 05/21/04 Prozac Weekly X X Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk
1 Day M 4156620 4377244 06/08/04 06/14/04 Zyprexa MD Bipolar Disorder Drug Exposure During Pregnancy, Neonatal Disorder, Sedation
1 Day F 4156643 4376073 05/30/01 06/07/04 Depakene X OT Drug Exposure During Pregnancy Congenital Nose Malformation, Congenital Ventricular Septal Defect, Difficulty In Walking, Foetal Valproate Syndrome, Hypoglycaemia Neonatal, Hypotonia Neonatal, Maternal Drugs Affecting Foetus, Neonatal Disorder
1 Day F 4157068 4377691 06/06/00 06/08/04 Valproate Sodium X Congenital Anomaly, Drug Exposure During Pregnancy, Foetal Valproate Syndrome
1 Day F 4159684 4385050 11/01/03 06/25/04 Deroxat X X X CN Ill-Defined Disorder Drug Exposure During Pregnancy, Hypotonia Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day Ns 4160926 4382223 06/16/04 Effexor X X X Depression Blindness Congenital, Cerebral Atrophy Congenital, Drug Exposure During Pregnancy, Epilepsy Congenital
1 Day 4160926 4382346 06/16/04 Effexor X X X Depression Blindness Congenital, Cerebral Atrophy Congenital, Congenital Anomaly, Drug Exposure During Pregnancy, Epilepsy Congenital
1 Day M 4162579 4383930 01/01/04 06/21/04 Risperdal MD Drug Use for Unknown Indication Congenital Anomaly, Drug Exposure During Pregnancy
1 Day M 4162579 4395823 01/01/04 07/07/04 Risperdal MD Drug Exposure During Pregnancy
1 Day M 4162604 4383940 03/21/04 06/21/04 Risperdal OT Adverse Event Congenital Anomaly, Drug Exposure During Pregnancy, Dystonia, Hypotonia Neonatal
1 Day F 4163209 4386405 06/23/04 Atarax OT Ill-Defined Disorder Complications of Maternal Exposure To Therapeutic Drugs
1 Day F 4163690 4386400 06/23/04 Atarax OT Ill-Defined Disorder Drug Exposure During Pregnancy, Neonatal Disorder
1 Day M 4164053 4386180 06/22/04 Zoloft X X MD Ill-Defined Disorder Bradycardia, Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Heart Rate Increased, Neonatal Disorder, Neonatal Respiratory Distress Syndrome
1 Day M 4164053 4517077 11/30/04 Zoloft X X MD Ill-Defined Disorder Bradycardia Neonatal, Cerebral Haemorrhage Neonatal, Cyanosis Neonatal, Drug Exposure During Pregnancy, Foetal Disorder, Neonatal Disorder, Neonatal Respiratory Distress Syndrome
1 Day M 4164360 4386849 03/25/04 06/23/04 Prozac X X Agitation Neonatal, Drug Exposure During Pregnancy, Hypotonia Neonatal, Tremor Neonatal
1 Day F 4168234 4391611 01/13/04 07/01/04 Zyprexa MD Drug Exposure During Pregnancy, Neonatal Tachypnoea
1 Day M 4191182 4420081 05/28/04 08/04/04 Fluoxetine X X Drug Exposure During Pregnancy, Hypokinesia Neonatal, Hypotonia Neonatal, Neonatal Disorder, Nervous System Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day 4194655 4426863 07/20/04 08/11/04 Zyprexa MD Circulatory Failure Neonatal, Drug Exposure During Pregnancy, Neonatal Disorder, Vomiting Neonatal
1 Day M 4194655 4448576 07/19/04 09/09/04 Zyprexa MD Abdominal Distension, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Disorder
1 Day 4195548 4426874 07/22/04 08/11/04 Olanzapine OT Drug Exposure During Pregnancy, Hypoglycaemia Neonatal, Neonatal Disorder, Neonatal Pneumonia, Tremor Neonatal
1 Day M 4197845 4435248 03/26/04 08/27/04 Seroxat X X X CN Depression Drug Exposure During Pregnancy, Hypoglycaemia, Musculoskeletal Stiffness, Myoclonus, Retching, Tremor, Vomiting, Weight Increased
1 Day M 4201214 4433176 01/01/02 08/23/04 Neurontin Epilepsy Congenital Atrial Septal Defect, Congenital Ventricular Septal Defect, Drug Exposure During Pregnancy, Hepatic Failure, Neonatal Cardiac Failure, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Thrombocytopenia Neonatal
1 Day M 4201901 4433970 08/10/04 08/25/04 Prozac X X MD Drug Exposure During Pregnancy
1 Day M 4201974 4434065 04/21/04 08/25/04 Prozac X X MD Bradycardia Neonatal, Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus, Neonatal Disorder, Neonatal Respiratory Distress Syndrome
1 Day M 4201974 4483359 04/21/04 10/20/04 Prozac X X MD Bradycardia Neonatal, Cyanosis Neonatal, Hypothermia Neonatal, Intraventricular Haemorrhage Neonatal, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Neonatal Disorder, Neonatal Respiratory Distress Syndrome
1 Day M 4211252 4448943 12/18/97 09/09/04 Zyprexa Drug Exposure During Pregnancy
1 Day F 4213873 4450269 09/01/04 09/14/04 Alprazolam PH Panic Disorder Drug Exposure During Pregnancy, Respiratory Disorder Neonatal
1 Day F 4213873 4466153 09/01/04 09/30/04 Alprazolam PH Panic Disorder Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder, Neonatal Respiratory Acidosis, Neonatal Respiratory Arrest, Respiratory Disorder Neonatal
1 Day 4214635 4450561 07/16/04 09/14/04 Ambien MD Maternal Drugs Affecting Foetus
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day 4214635 4469486 07/16/04 10/05/04 Ambien MD Congenital Bladder Anomaly, Drug Exposure During Pregnancy
1 Day M 4217877 4455780 03/04/94 09/17/04 Valproate Sodium X Congenital Anomaly, Drug Exposure During Pregnancy, Foetal Valproate Syndrome
1 Day F 4218971 4457524 07/16/04 09/22/04 Zyprexa Drug Exposure During Pregnancy, Neonatal Aspiration
1 Day 4223065 4462429 08/10/04 09/24/04 Effexor LP X X X MD Depression Drug Exposure During Pregnancy, Hypotonia Neonatal
1 Day M 4224863 4463929 09/29/04 Tranxene Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Foetal Heart Rate Decreased, Sedation
1 Day M 4224863 4471954 10/07/04 Tranxene MD Maternal Drugs Affecting Foetus Drug Exposure During Pregnancy, Foetal Disorder, Foetal Heart Rate Decreased, Neonatal Respiratory Arrest, Sedation
1 Day M 5569741 4422029 08/04/04 Prozac X X Autism, Drug Exposure During Pregnancy, Hypoglycaemia Neonatal, Hypothermia Neonatal, Neonatal Disorder
1 Day F 5659091 4493730 01/01/03 11/05/04 Ergenyl X Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Hypotonia, Hypotonia Neonatal
1 Day F 5660337 4495064 01/01/90 11/08/04 Valproic Acid X Drug Exposure During Pregnancy Heart Disease Congenital, Maternal Drugs Affecting Foetus
1 Day 5661397 4489020 09/10/04 10/26/04 Zyprexa MD Drug Exposure During Pregnancy
1 Day 5672867 4494354 11/02/04 Fluoxetine HCL X X MD Congenital Ventricular Septal Defect, Drug Exposure During Pregnancy
1 Day 5672870 4494355 11/02/04 Fluoxetine HCL X X MD Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day M 5688198 4510245 08/23/04 11/19/04 Fluoxetine X X MD Drug Exposure During Pregnancy, Haemangioma Congenital, Tremor Neonatal
1 Day M 5688198 4618328 08/23/04 03/24/05 Fluoxetine X X MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Haemangioma Congenital, Rash, Tremor Neonatal
1 Day M 5691532 4517235 09/28/04 11/30/04 Prozac X X MD Drug Exposure During Pregnancy, Feeling Jittery, Retching
1 Day 5692807 4523967 01/01/93 12/10/04 Depakene X Autism, Congenital Foot Malformation, Drug Exposure During Pregnancy, Foetal Valproate Syndrome
1 Day F 5707491 4530361 11/17/04 12/15/04 Clonidine Drug Exposure During Pregnancy, Hypertension Neonatal
1 Day M 5711903 4543961 01/03/05 Paroxetine X X X MD Cerebral Atrophy Congenital, Congenital Neurological Disorder, Drug Exposure During Pregnancy, Epilepsy Congenital, Hypotonia Neonatal, Intraventricular Haemorrhage Neonatal, Neonatal Apnoeic Attack, Stereotypic Movement Disorder
1 Day M 5711903 4587966 02/15/05 Paroxetine HCL X X X MD Congenital Neurological Disorder, Convulsion Neonatal, Drug Exposure During Pregnancy, Epilepsy, Hypotonia Neonatal, Intraventricular Haemorrhage Neonatal, Lethargy, Neonatal Apnoeic Attack, Stereotypic Movement Disorder
1 Day M 5711903 4589473 02/16/05 Paroxetine HCL X X X MD Drug Exposure During Pregnancy, Intraventricular Haemorrhage Neonatal, Neonatal Apnoeic Attack, Neonatal Disorder
1 Day F 5724131 4563004 02/01/04 01/27/05 Depakote X Drug Exposure During Pregnancy Congenital Arterial Malformation, Congenital Cardiovascular Anomaly, Foetal Growth Retardation
1 Day 5728570 4567784 01/13/05 01/27/05 Alprazolam PH Ill-Defined Disorder Drug Exposure During Pregnancy, Neonatal Disorder
1 Day M 5728570 4585441 01/10/05 02/14/05 Alprazolam PH Ill-Defined Disorder Congenital Anomaly, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Disorder, Neonatal Infection, Somnolence Neonatal
1 Day M 5728570 4594850 01/12/05 02/23/05 Alprazolam PH Anxiety Anxiety, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day M 5731094 4727698 09/08/04 07/27/05 09/21/04 Citalopram HBr X X X Depression Camptodactyly Congenital, Cerebral Haemorrhage, Congenital Multiplex Arthrogryposis, Drug Exposure During Pregnancy, Foetal Disorder, Foetal Distress Syndrome, Hypokinesia Neonatal, Muscular Weakness
1 Day M 5731094 4758951 09/08/04 08/26/05 09/21/04 Citalopram HBr X X X OT Depression Akinesia, Camptodactyly Congenital, Cerebral Haemorrhage Neonatal, Congenital Hand Malformation, Congenital Multiplex Arthrogryposis, Death Neonatal, Drug Exposure During Pregnancy, Foetal Disorder, Foetal Distress Syndrome, Hypokinesia Neonatal, Neonatal Cholestasis, Neonatal Hypoxia
1 Day M 5731094 4759161 09/08/04 08/31/05 09/21/04 Citalopram HBr X X X PH Depression Akinesia, Camptodactyly Congenital, Cerebral Haemorrhage, Congenital Multiplex Arthrogryposis, Congenital Neurological Disorder, Congenital Oral Malformation, Congenital Pulmonary Hypertension, Death Neonatal, Drug Exposure During Pregnancy, Hypokinesia Neonatal, Neonatal Hypoxia
1 Day M 5731094 4785157 09/08/04 09/28/05 09/21/04 Citalopram HBr X X X OT Depression Akinesia, Camptodactyly Congenital, Cerebral Haemorrhage, Congenital Multiplex Arthrogryposis, Death Neonatal, Drug Exposure During Pregnancy, Foetal Disorder
1 Day F 5736798 4579702 11/18/02 02/14/05 Depakene X Drug Exposure During Pregnancy Drug Exposure During Pregnancy
1 Day F 5739177 4572060 09/23/04 02/02/05 Zyprexa OT Drug Exposure During Pregnancy
1 Day F 5739177 4658387 09/23/04 05/09/05 Zyprexa OT Drug Exposure During Pregnancy, Neonatal Disorder
1 Day F 5739177 4853092 09/23/04 12/12/05 Zyprexa OT Drug Exposure During Pregnancy, Feeding Disorder Neonatal
1 Day M 5744291 4589528 01/01/05 02/23/05 Risperdal MD Drug Use for Unknown Indication Drug Withdrawal Syndrome Neonatal
1 Day 5745907 4591474 02/25/05 Depakene X Drug Exposure During Pregnancy Hypotonia Neonatal
1 Day M 5749932 4596731 07/15/03 03/02/05 Lamictal X X CN Epilepsy Drug Exposure During Pregnancy
1 Day M 5751399 4591145 12/03/04 02/23/05 Paxil CR X X X OT Anxiety, Panic Disorder Congenital Anomaly, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeling Jittery, Neonatal Disorder, Neonatal Respiratory Arrest, Nervous System Disorder, Sepsis Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day F 5753511 4595935 11/25/04 02/24/05 Fluoxetine X X MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
1 Day F 5753511 4599931 11/25/04 03/03/05 Fluoxetine X X MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia, Tremor
1 Day F 5753511 4613362 11/25/04 03/16/05 Fluoxetine X X MD Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Neonatal Disorder, Tremor Neonatal
1 Day M 5754507 4596184 02/03/05 02/25/05 Effexor XR X X X Depression Convulsion Neonatal, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypothermia Neonatal, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Hypoxia, Tremor Neonatal
1 Day M 5757918 4599505 06/12/99 03/03/05 Phenergan X Nausea Drug Exposure During Pregnancy, Dysphagia, Neonatal Disorder, Speech Disorder
1 Day F 5757919 4599510 08/28/02 03/03/05 Phenergan X Nausea Cerebrovascular Accident, Drug Exposure During Pregnancy, Speech Disorder
1 Day M 5757920 4599529 07/25/00 03/03/05 Phenergan X Nausea Drug Exposure During Pregnancy, Dysphagia, Neonatal Disorder
1 Day M 5759143 4600457 03/04/05 Clozapine X MD Schizophrenia Coma Neonatal, Congenital Anomaly, Congenital Central Nervous System Anomaly, Congenital Floppy Infant, Convulsion Neonatal, Drug Exposure During Pregnancy, Encephalopathy Neonatal, Foetal Arrhythmia, Foetal Disorder, Heart Disease Congenital, Hernia Congenital, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Respiratory Failure
1 Day Unk 5759880 4606782 07/01/04 01/16/05 Effexor X X X PH Anxiety, Depression Convulsion, Drug Exposure During Pregnancy, Musculoskeletal Stiffness
1 Day F 5768182 4616141 04/07/02 03/21/05 Anafranil X X OT Drug Exposure During Pregnancy, Extrapyramidal Disorder, Foetal Disorder, Hypoglycaemia Neonatal, Neonatal Disorder
1 Day M 5769719 4618266 01/27/05 03/24/05 Anafranil X X Agitation, Crying, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Cardiac Disorder, Gastrointestinal Disorder Congenital, Hypotonia Neonatal
1 Day 5769841 4618342 03/24/05 Zyprexa MD Congenital Anomaly, Drug Exposure During Pregnancy, Multiple Congenital Abnormalities
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
24 Hours F 5771031 4677419 05/26/05 Effexor XR X X X Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
1 Day M 5779305 4634422 11/22/04 04/11/05 Effexor X X X Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Fever Neonatal, Neonatal Tachypnoea, Vomiting Neonatal
1 Day F 5781756 4638193 03/04/05 04/18/05 Zyprexa MD Drug Exposure During Pregnancy, Dyskinesia Neonatal, Hypotonia Neonatal
1 Day F 5781756 4684547 03/04/05 05/31/05 Zyprexa MD Dyskinesia Neonatal, Hypotonia Neonatal
1 Day F 5781756 4713680 03/04/05 07/13/05 Zyprexa OT Cyanosis Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal, Feeding Disorder Neonatal, Hypotonia Neonatal, Neonatal Apnoeic Attack, Neonatal Disorder
1 Day M 5782758 4638228 03/25/05 04/15/05 Zyprexa OT Drug Exposure During Pregnancy, Neonatal Respiratory Depression
1 Day M 5782758 4697592 03/25/05 06/21/05 Zyprexa OT Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome
1 Day M 5784815 4641604 03/28/96 04/20/05 Lamictal X X MD Anomaly of External Ear Congenital, Drug Exposure During Pregnancy, Multiple Congenital Abnormalities, Tremor Neonatal
1 Day F 5785014 4631784 07/22/03 03/30/05 Valproate Sodium X OT Congenital Musculoskeletal Anomaly
1 Day F 5786740 4642928 02/14/01 04/21/05 Valproate Sodium X Aphasia, Camptodactyly Congenital, Congenital Anomaly of Inner Ear, Congenital Central Nervous System Anomaly, Congenital Eye Disorder, Convulsion Neonatal, Deafness Congenital, Drug Exposure During Pregnancy, Encephalopathy Neonatal, Hypotonia Neonatal, Multiple Congenital Abnormalities, Neonatal Tachypnoea
1 Day M 5787213 4632422 07/14/03 04/01/05 Depakote X Congenital Musculoskeletal Anomaly, Multiple Congenital Abnormalities
1 Day F 5788476 4642973 02/01/04 04/22/05 Depakote X Congenital Arterial Malformation, Congenital Cardiovascular Anomaly, Foetal Growth Retardation
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day F 5788476 4647800 02/01/04 04/26/05 Depakote X CN Drug Exposure During Pregnancy, Foetal Growth Retardation, Heart Disease Congenital
1 Day F 5790381 4648979 02/16/05 04/27/05 Sarafem X X Drug Exposure During Pregnancy, Foetal Heart Rate Decreased
1 Day F 5790381 4784963 02/16/05 09/28/05 Sarafem X X MD Drug Exposure During Pregnancy, Foetal Heart Rate Deceleration
1 Day F 5791385 4650077 01/01/04 04/28/05 Effexor X X X Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Hypotension, Neonatal Respiratory Failure
1 Day M 5798139 4785309 01/26/01 09/29/05 Risperdal MD Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus Congenital Anomaly, Drug Exposure During Pregnancy
1 Day M 5802390 4662638 10/27/04 05/12/05 Zyprexa MD Drug Exposure During Pregnancy
1 Day M 5802390 4681874 10/27/04 06/02/05 Zyprexa MD Drug Exposure During Pregnancy
1 Day F 5802960 4672722 05/24/05 Tegretol X Drug Exposure During Pregnancy, Foetal Distress Syndrome, Hypotonia Neonatal
1 Day M 5803399 4665076 01/03/05 05/17/05 01/03/05 Zyprexa MD Cardiomegaly, Death Neonatal, Drug Exposure During Pregnancy, Neonatal Disorder
1 Day F 5803809 4686515 04/27/05 06/09/05 Tegretol X Drug Exposure During Pregnancy
1 Day F 5803809 4698871 04/27/05 06/24/05 Tegretol X Drug Exposure During Pregnancy
1 Day M 5811957 4678733 01/01/04 05/31/05 Effexor XR X X X Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day F 5814225 4685397 01/06/04 06/08/05 Deroxat X X X CN Agitation, Agitation Neonatal, Drug Exposure During Pregnancy, Eating Disorder, Hypertonia, Hypertonia Neonatal, Hypotonia, Hypotonia Neonatal, Respiratory Disorder Neonatal
1 Day F 5820115 4686967 06/06/05 Zoloft X X MD Arrhythmia Neonatal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Neonatal Tachycardia
1 Day 5820728 4686762 06/06/05 Fluoxetine HCL X X MD Coma, Drug Exposure During Pregnancy, Neonatal Disorder
1 Day M 5832301 4494276 11/02/04 Prozac X X MD Agitation Neonatal, Congenital Hand Malformation, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Toxicity, Dyskinesia, Hypertonia, Jaundice Neonatal, Neonatal Respiratory Distress Syndrome, Neonatal Tachypnoea, Rash Neonatal, Sepsis Neonatal, Tremor Neonatal
1 Day M 5832303 4693001 05/17/05 06/15/05 Prozac X X MD Cyanosis Neonatal, Drug Exposure During Pregnancy, Feeling Jittery, Neonatal Disorder
1 Day 5834272 4854430 12/13/05 Zyprexa MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Infection, Neonatal Pneumonia
1 Day 5837319 4708882 09/19/04 07/05/05 03/29/05 Fluoxetine X X OT Congenital Multiplex Arthrogryposis, Drug Exposure During Pregnancy
1 Day M 5843028 4714041 07/12/05 Serax OT Depression Abnormal Behaviour, Cerebral Atrophy Congenital, Congenital Central Nervous System Anomaly, Congenital Hair Disorder, Congenital Nail Disorder, Drug Exposure During Pregnancy, Epilepsy
1 Day F 5845358 4716551 07/14/05 Escitalopram Oxalate X X X OT Drug Exposure During Pregnancy, Neonatal Respiratory Depression
1 Day F 5845358 4724880 07/21/05 Escitalopram Oxalate X X X PH Drug Exposure During Pregnancy, Neonatal Respiratory Depression
1 Day F 5845394 4716477 07/13/05 Olanzapine MD Drug Exposure During Pregnancy
1 Day F 5845394 4738626 08/03/05 Olanzapine MD Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day M 5849880 4730234 04/01/04 08/01/05 Risperdal MD Drug Use for Unknown Indication Drug Exposure During Pregnancy
1 Day F 5850779 4724507 07/21/05 Celexa X X X Drug Exposure During Pregnancy, Neonatal Disorder
1 Day F 5850786 4724523 07/21/05 Celexa X X X Crying, Drug Exposure During Pregnancy, Neonatal Disorder
1 Day F 5850786 4726488 07/26/05 Celexa X X X Crying, Drug Exposure During Pregnancy, Neonatal Disorder
1 Day M 5852043 4734602 04/01/05 08/04/05 Seroquel X X X MD Cyanosis Neonatal, Drug Exposure During Pregnancy
1 Day M 5852043 4735782 04/01/05 08/05/05 Seroquel X X X MD Cyanosis Neonatal, Drug Exposure During Pregnancy
1 Day M 5857859 4736710 08/02/05 Atarax OT Ill-Defined Disorder Agitation Neonatal, Drug Exposure During Pregnancy, Tremor Neonatal
1 Day M 5859865 4736978 07/12/05 08/04/05 Citalopram HBr X X X OT Panic Disorder Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal, Irritability, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Respiratory Disorder Neonatal, Tremor Neonatal
1 Day M 5859865 4865793 07/12/05 12/20/05 Citalopram HBr X X X PH Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Hypotonia Neonatal, Irritability, Neonatal Asphyxia, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Tremor Neonatal
1 Day M 5862487 4742387 02/01/03 08/08/05 Neurontin OT Migraine Congenital Anomaly, Drug Exposure During Pregnancy
1 Day M 5862487 4775157 04/03/03 09/20/05 Neurontin Migraine Drug Exposure During Pregnancy, Jaundice Neonatal
1 Day 5877815 4765256 08/15/05 09/06/05 Prozac X X Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day M 5877815 4824590 07/15/05 11/08/05 Prozac X X Congenital Anomaly, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea, Hypoglycaemia Neonatal
1 Day M 5881374 4767761 08/25/05 09/12/05 Alprazolam MD Ill-Defined Disorder Convulsion Neonatal, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hypertonia Neonatal
1 Day M 5881374 4781471 09/27/05 Alprazolam MD Ill-Defined Disorder Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypertonia Neonatal, Tremor
1 Day F 5882292 4770950 05/08/05 09/14/05 Prozac X X MD Congenital Anomaly, Convulsion Neonatal, Drug Exposure During Pregnancy, Dysphagia, Hypotonia Neonatal, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Infection, Neonatal Respiratory Distress Syndrome
1 Day F 5886269 4776919 09/10/05 09/22/05 Tegretol X MD Convulsion Congenital Anomaly, Drug Exposure During Pregnancy
1 Day F 5887379 4777491 08/22/05 09/15/05 Provigil OT Somnolence Convulsion Neonatal, Drug Exposure During Pregnancy, Respiratory Disorder Neonatal
1 Day F 5887379 4810772 08/22/05 10/24/05 Provigil OT Somnolence Convulsion Neonatal, Drug Exposure During Pregnancy, Respiratory Disorder Neonatal
1 Day F 5890877 4781137 11/22/03 09/26/05 Zoloft X X MD Ill-Defined Disorder Congenital Nose Malformation, Congenital Nystagmus, Drug Exposure During Pregnancy, Neonatal Disorder, Strabismus Congenital
1 Day M 5892247 4786801 03/16/05 10/03/05 Paxil X X X Depression, Stress Arrhythmia Neonatal, Drug Exposure During Pregnancy, Neonatal Disorder
1 Day F 5892732 4784419 03/04/04 09/28/05 Zyprexa OT Anxiety, Blood Glucose Increased, Diabetes Mellitus Non-Insulin-Dependent, Malaise, Nausea, Vomiting
1 Day F 5907197 4822116 06/30/05 11/03/05 Olanzapine Drug Exposure During Pregnancy, Feeding Disorder Neonatal
1 Day F 5907197 4853517 12/12/05 Olanzapine Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Somnolence Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day M 5910628 4806709 10/19/05 Fluoxetine HCL X X MD Drug Exposure During Pregnancy
1 Day M 5911905 4806496 04/08/05 10/19/05 Strattera X X CN Drug Exposure During Pregnancy
1 Day 5915093 4806978 05/01/05 10/19/05 Prozac X X MD Drug Exposure During Pregnancy
1 Day F 5915929 4809699 03/03/04 10/21/05 Zyprexa Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Lethargy, Neonatal Disorder
1 Day F 5921771 4822317 10/04/05 11/03/05 Zyprexa MD Drug Exposure During Pregnancy, Extrapyramidal Disorder, Respiratory Disorder Neonatal
1 Day F 5921771 5141735 10/04/05 10/27/06 Zyprexa MD Drug Exposure During Pregnancy, Extrapyramidal Disorder, Neonatal Disorder, Neonatal Respiratory Depression
1 Day M 5922274 4821948 12/12/04 11/03/05 Temesta OT Drug Exposure During Pregnancy
1 Day M 5928861 4831155 08/21/05 11/14/05 Lorazepam Schizophrenia Drug Exposure During Pregnancy, Maternal Use of Illicit Drugs
1 Day M 5928861 5135850 08/21/05 10/20/06 Lorazepam Schizophrenia Drug Exposure During Pregnancy
1 Day M 5934194 4708427 07/05/05 Effexor X X X Depression Cerebral Atrophy Congenital, Congenital Anomaly, Congenital Central Nervous System Anomaly, Congenital Hair Disorder, Congenital Nail Disorder, Drug Exposure During Pregnancy, Epilepsy, Neonatal Disorder
1 Day M 5934396 4843827 01/01/05 12/02/05 Deroxat X X X CN Congenital Genitourinary Abnormality, Drug Exposure During Pregnancy
1 Day M 5934396 4854753 01/01/05 12/15/05 Deroxat X X X CN Congenital Genitourinary Abnormality, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day M 5937224 4847507 12/07/05 Imipramine X X Circulatory Failure Neonatal
1 Day M 5937224 4876365 01/01/01 01/10/06 Tofranil X X Circulatory Failure Neonatal, Drug Exposure During Pregnancy
1 Day F 5948425 4852797 08/03/00 12/12/05 Paxil X X X CN Depression, Suicidal Ideation Drug Exposure During Pregnancy, Heart Disease Congenital
1 Day F 5953854 4899301 10/17/05 01/31/06 Zoloft X X MD Ill-Defined Disorder Diarrhoea, Drug Exposure During Pregnancy
1 Day F 5955277 4909027 02/04/05 02/13/06 Luvox X X MD Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal, Respiratory Disorder Neonatal, Tremor Neonatal
1 Day F 5958601 4871124 12/29/05 Fontex X X Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
1 Day F 5959051 4870291 12/04/05 12/28/05 Zyprexa PH Haemangioma Congenital
1 Day M 5961288 4881540 04/06/04 01/16/06 Deroxat X X X CN Congenital Genitourinary Abnormality, Drug Exposure During Pregnancy
1 Day F 5961722 4881965 01/08/06 01/17/06 Paxil X X X MD Drug Exposure During Pregnancy, Somnolence Neonatal
1 Day F 5961722 4902788 01/08/06 02/07/06 Paxil X X X MD Drug Exposure During Pregnancy, Neonatal Asphyxia, Somnolence Neonatal
1 Day F 5961722 4909352 01/08/06 02/13/06 Paxil X X X MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Asphyxia, Somnolence Neonatal
1 Day F 5961722 4946568 01/08/06 03/17/06 Paxil X X X MD Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia, Hypotonia Neonatal, Irritability, Neonatal Asphyxia, Neonatal Respiratory Failure, Neonatal Tachypnoea, Somnolence Neonatal, Tremor
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
24 Hours M 5972394 4895063 01/30/06 Tegretol X Drug Exposure During Pregnancy, Somnolence Neonatal
1 Day F 5972500 4895209 11/09/05 01/30/06 Luvox X X MD Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal, Hypertonia, Irritability, Tremor
1 Day F 5972500 4916490 11/09/05 02/20/06 Luvox X X MD Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Irritability, Tremor Neonatal
24 Hours M 5972729 4895563 01/30/06 Rivotril CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Somnolence
1 Day Unk 5976864 4895608 01/01/97 01/25/06 01/01/97 Zyprexa MD Drug Exposure During Pregnancy, Drug Toxicity
1 Day F 5981216 4899760 12/01/05 01/31/06 01/18/06 Zoloft X X Ill-Defined Disorder Drug Exposure During Pregnancy, Respiratory Disorder Neonatal
1 Day F 5981216 4983107 12/01/05 04/20/06 01/18/06 Zoloft X X MD Ill-Defined Disorder Drug Exposure During Pregnancy, Foetal Cardiac Disorder
1 Day 5981364 4907578 02/10/06 Valproate Sodium X Drug Exposure During Pregnancy, Foetal Valproate Syndrome
1 Day F 5988305 4968025 01/01/06 04/10/06 Tegretol X Agitation Neonatal, Congenital Pulmonary Valve Disorder, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Fever Neonatal, Foetal Heart Rate Disorder, Hypertonia Neonatal, Neonatal Tachypnoea
1 Day 5991645 4909921 02/08/06 Atarax Ill-Defined Disorder Drug Exposure During Pregnancy, Irritability, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Sleep Disorder, Tremor Neonatal
1 Day M 5997905 4918368 01/11/06 02/14/06 Zyprexa MD Obsessive-Compulsive Personality Disorder Bradycardia Foetal, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Hypotonia Neonatal, Hypoventilation Neonatal, Neonatal Disorder, Sedation, Tremor Neonatal
1 Day 5997905 4936714 11/11/05 03/02/06 Zyprexa MD Obsessive-Compulsive Personality Disorder Bradycardia Neonatal, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Foetal Distress Syndrome, Hypotonia Neonatal, Hypoventilation Neonatal, Neonatal Disorder, Neonatal Hypoxia, Sedation, Tremor Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day Unk 5997905 4936902 11/11/05 03/02/06 Zyprexa MD Obsessive-Compulsive Personality Disorder Bradycardia Foetal, Chorea, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Foetal Distress Syndrome, Hypokinesia Neonatal, Hypotonia Neonatal, Hypoventilation Neonatal, Neonatal Disorder, Respiratory Disorder Neonatal, Somnolence Neonatal, Tremor Neonatal
1 Day 5997905 4990741 11/11/05 04/28/06 Zyprexa Obsessive-Compulsive Personality Disorder Bradycardia Foetal, Chorea, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Foetal Distress Syndrome, Hypokinesia Neonatal, Hypotonia Neonatal, Hypoventilation Neonatal, Somnolence Neonatal, Tremor Neonatal
1 Day 6026592 4974078 01/01/05 04/17/06 01/31/06 Paroxetine HCL X X X CN Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy
1 Day M 6032369 4975187 02/02/06 04/17/06 Paxil X X X MD Depression Drug Exposure During Pregnancy
1 Day 6036412 4979526 04/18/06 Fontex X X MD Drug Exposure During Pregnancy
1 Day F 6036548 4979326 01/01/04 04/18/06 Zyprexa OT Drug Exposure During Pregnancy, Pilonidal Cyst Congenital
1 Day F 6041457 4996894 05/09/06 Lamictal X X CN Epilepsy Anaemia, Drug Exposure During Pregnancy
1 Day F 6045005 4990722 11/24/05 04/27/06 Lexapro X X X MD Anxiety Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyskinesia, Insomnia, Neonatal Respiratory Distress Syndrome, Restlessness, Screaming
1 Day F 6045005 5027330 11/24/05 06/12/06 Lexapro X X X MD Anxiety, Depression Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Insomnia, Neonatal Respiratory Distress Syndrome, Restlessness, Screaming
1 Day F 6045428 4891820 10/04/05 01/23/06 Zyprexa PH Congenital Anomaly
1 Day M 6050572 5008988 05/01/05 05/23/06 Stilnox OT Sleep Disorder Drug Exposure During Pregnancy
1 Day F 6057395 5017305 01/01/87 06/02/06 01/01/87 Epilim X CN Drug Exposure During Pregnancy Death
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day F 6059049 5019008 06/06/06 Deroxat X X X CN Congenital Diaphragmatic Hernia, Drug Exposure During Pregnancy, Pulmonary Artery Stenosis Congenital
1 Day F 6062468 5016849 08/19/05 05/26/06 Prozac X X MD Agitation Neonatal, Drug Exposure During Pregnancy, Foetal Growth Retardation, Neonatal Respiratory Distress Syndrome
1 Day M 6062646 5018185 02/04/06 05/30/06 Xanax MD Anxiety Drug Exposure During Pregnancy
1 Day M 6064876 5025938 05/02/06 06/14/06 Paxil X X X MD Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Disorder, Pyrexia, Tremor Neonatal
1 Day M 6064876 5035624 05/02/06 06/27/06 Paxil X X X MD Depression Crying, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Disorder, Pyrexia, Tremor Neonatal
1 Day M 6064876 5063468 05/02/06 07/27/06 Paxil X X X MD Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Disorder, Neonatal Tachypnoea, Pyrexia, Tremor Neonatal
1 Day M 6064876 5067790 05/02/06 08/02/06 Paxil X X X MD Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Disorder, Pyrexia, Tremor Neonatal
1 Day F 6093118 5042947 01/01/05 06/27/06 Zyprexa MD Schizophrenia Delirium, Drug Exposure During Pregnancy
1 Day F 6098314 5070452 01/01/89 08/04/06 Epilim X CN Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Foetal Anticonvulsant Syndrome
1 Day F 6099180 5065014 11/14/05 07/26/06 Venlafaxine HCL X X X Anxiety, Depression, Panic Attack Drug Exposure During Pregnancy, Neonatal Disorder
1 Day F 6102965 5071487 07/27/06 08/03/06 Prozac X X MD Depression Cyanosis Neonatal, Drug Exposure During Pregnancy, Heart Disease Congenital, Neonatal Disorder
1 Day 6107673 5074354 08/03/06 Prozac X X Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day 6107690 5074406 08/03/06 Prozac X X Drug Exposure During Pregnancy
1 Day F 6125908 5094409 05/18/06 08/30/06 Prozac X X Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Extrapyramidal Disorder, Neonatal Disorder
1 Day M 6126787 5103900 09/13/06 Ritalin X MD Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome
1 Day 6126850 5096388 08/30/06 Zyprexa MD Congenital Anomaly, Drug Exposure During Pregnancy
1 Day 6126850 5106684 09/13/06 Zyprexa MD Drug Exposure During Pregnancy
1 Day 6126850 5117718 09/26/06 Zyprexa MD Congenital Anomaly, Drug Exposure During Pregnancy
1 Day F 6126850 5123418 10/05/06 Zyprexa MD Congenital Anomaly, Drug Exposure During Pregnancy
1 Day F 6129015 5105876 06/01/05 09/15/06 Deroxat X X X CN Agitation, Crying, Diarrhoea Neonatal, Drug Exposure During Pregnancy, Hypertonia, Suicide Attempt, Tremor, Vomiting Neonatal
1 Day M 6129138 5106039 02/15/02 09/15/06 Depakote X OT Drug Exposure During Pregnancy Dacryostenosis Congenital, Drug Exposure During Pregnancy
1 Day M 6129138 5106041 02/15/02 09/15/06 Depakote X OT Drug Exposure During Pregnancy Dacryostenosis Congenital, Drug Exposure During Pregnancy
1 Day Ns 6140196 5110150 09/18/06 Effexor X X X OT Depression Drug Exposure During Pregnancy, Necrotising Enterocolitis Neonatal, Neonatal Respiratory Failure
1 Day M 6141004 5110549 01/01/03 09/18/06 Effexor XR X X X CN Depression Drug Exposure During Pregnancy, Neonatal Respiratory Failure, Respiratory Disorder Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day F 6144103 5123768 06/15/06 10/10/06 Valium CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hypotonia, Hypotonia Neonatal, Malaise, Somnolence, Somnolence Neonatal
1 Day 6145584 5120627 07/01/06 10/02/06 Zyprexa MD Agitation Neonatal, Drug Exposure During Pregnancy, Somnolence Neonatal
1 Day M 6150276 5127346 05/04/05 10/10/06 Xanax OT Congenital Mitral Valve Incompetence, Heart Disease Congenital
1 Day F 6150557 5131418 08/01/06 10/20/06 Lamictal X X CN Epilepsy Drug Exposure During Pregnancy, Foetal Distress Syndrome
1 Day M 6151530 5132734 04/01/06 10/23/06 08/21/06 Lamictal X X MD Epilepsy Cardiac Arrest, Drug Exposure During Pregnancy
1 Day M 6151530 5154009 04/01/06 11/20/06 08/21/06 Lamictal X X MD Epilepsy Cardiac Arrest, Drug Exposure During Pregnancy
1 Day M 6151530 5179336 12/19/06 08/21/06 Lamictal X X MD Epilepsy Cardiac Arrest, Drug Exposure During Pregnancy
1 Day F 6153168 5134650 01/04/06 10/25/06 Deroxat X X X CN Drug Exposure During Pregnancy, Hypotonia Neonatal, Somnolence Neonatal
1 Day M 6160363 5142020 07/10/05 11/02/06 Tegretol X MD Drug Exposure During Pregnancy
1 Day 6167107 5141849 03/19/06 10/27/06 Zyprexa Drug Exposure During Pregnancy, Hypotonia Neonatal, Maternal Condition Affecting Foetus, Neonatal Respiratory Distress Syndrome
1 Day F 6172184 5156101 02/01/06 11/22/06 Tegretol X Agitation, Coordination Abnormal, Crying, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Growth Retardation, Foetal Heart Rate Deceleration, Jaundice Neonatal, Pyrexia, Tremor Neonatal, Weight Decreased
1 Day M 6173142 5150369 06/05/06 11/08/06 Atarax OT Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypotonia Neonatal, Neonatal Disorder
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Day F 6173556 5157437 11/27/06 Prozac X X MD Drug Exposure During Pregnancy
1 Day F 6174697 5151736 01/01/01 11/07/06 Prozac X X CN Congenital Tracheomalacia, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Heart Disease Congenital, Hypertonia Neonatal
1 Day F 6180528 5158841 08/07/06 11/17/06 Xanax OT Bipolar Disorder Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Respiratory Distress Syndrome
1 Day 6187226 5174301 12/14/06 Olanzapine MD Drug Exposure During Pregnancy
1 Day 6198477 5186436 09/15/98 12/20/06 Prozac X X MD Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Growth Retardation
1 Day M 6205298 5179779 06/15/06 12/12/06 Xanax OT Agitation Neonatal, Congenital Hearing Disorder, Congenital Jaw Malformation, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Neonatal Respiratory Distress Syndrome, Pilonidal Cyst Congenital
1 Day F 6220570 5201748 10/26/05 10/13/06 Lexapro X X X MD Hypokinesia Neonatal, Hypotonia Neonatal, Somnolence Neonatal
30 Hours M 5899292 4791869 10/05/05 Fluoxetine X X Depression Drug Exposure During Pregnancy, Neonatal Disorder
1 Days M 5919206 4816167 01/01/04 10/26/05 Fluoxetine X X MD Depression Drug Exposure During Pregnancy, Neonatal Disorder
2 Days M 4014415 4277679 06/14/03 01/21/04 Zyprexa MD Maternal Drugs Affecting Foetus, Neonatal Disorder, Neonatal Tachypnoea
2 Days M 4014415 4284730 06/14/03 01/30/04 Zyprexa MD Maternal Drugs Affecting Foetus, Neonatal Disorder, Neonatal Infection, Respiratory Disorder Neonatal
2 Days M 4098263 4299979 10/31/96 02/18/04 Depakine Chrono X CN Maternal Drugs Affecting Foetus, Tremor Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
2 Days F 4104939 4310414 01/01/03 03/01/04 Effexor XR X X X Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Maternal Drugs Affecting Foetus, Neonatal Disorder
2 Days M 4114644 4324809 09/20/03 03/26/04 Deroxat X X X CN Anxiety Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Tremor
2 Days M 4159787 4382393 06/16/04 06/21/04 Prozac X X MD Depression Agitation Neonatal, Diarrhoea Neonatal, Irritability, Neonatal Disorder
2 Days M 4187551 4417248 02/26/02 07/02/04 Neurontin Epilepsy Death Neonatal, Drug Exposure During Pregnancy
2 Days M 4192809 4428833 12/13/03 08/18/04 Deroxat X X X CN Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Neonatal Apnoeic Attack, Neonatal Tachycardia, Respiratory Disorder Neonatal, Tremor Neonatal
2 Days M 4197734 4431800 01/20/04 08/18/04 Prozac X X MD Abdominal Pain, Agitation, Crying, Drug Exposure During Pregnancy, Insomnia
2 Days M 4197734 4595505 01/20/04 02/24/05 Prozac X X MD Abdominal Pain, Agitation Neonatal, Drug Exposure During Pregnancy, Neonatal Disorder, Restlessness, Sleep Disorder, Vomiting Neonatal
2 Days 5733272 4574845 02/08/05 Paxil X X X CN Ill-Defined Disorder Feeling Jittery, Somnolence
2 Days M 5757436 4597966 02/23/05 03/01/05 Anafranil X X Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Tachycardia, Tremor Neonatal
2 Days M 5769923 4617899 01/23/05 03/22/05 Anafranil X X Agitation Neonatal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Neonatal Disorder, Neonatal Tachycardia, Tremor Neonatal
2 Days F 5882173 4773813 09/20/05 Wellbutrin X X X OT Major Depression Convulsion, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk
2 Days F 5882173 4795296 10/12/05 Wellbutrin X X X OT Major Depression Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
2 Days M 5918671 4818974 04/10/04 11/02/05 Zoloft X X Postpartum Depression, Prophylaxis Drug Exposure During Pregnancy
48 Hours 6001673 4939430 02/08/06 03/10/06 Abilify OT Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Sedation
2 Days 6009025 4940990 02/10/06 03/07/06 Lexapro X X X Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Neonatal Oversedation
2 Days Ns 6009631 4941905 02/08/06 03/08/06 Remeron X X X OT Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Neonatal Disorder, Nervous System Disorder, Sedation
2 Days F 6012290 4947279 02/27/06 03/13/06 Effexor XR X X X MD Drug Exposure During Pregnancy Agitation Neonatal, Drug Exposure During Pregnancy, Dyskinesia Neonatal
2 Days M 6041990 4977016 03/26/06 04/12/06 Ativan OT Drug Withdrawal Syndrome Agitation Neonatal, Diarrhoea Neonatal, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Foetal Distress Syndrome, Irritability, Muscle Rigidity, Muscle Spasms, Neonatal Disorder, Neonatal Tachypnoea, Restlessness, Tremor Neonatal
2 Days M 6041990 5036864 03/26/06 06/22/06 Ativan OT Drug Withdrawal Syndrome Agitation Neonatal, Diarrhoea Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Foetal Distress Syndrome, Irritability, Muscle Rigidity, Muscle Spasms, Nervous System Disorder, Restlessness, Tremor Neonatal
2 Days 6060680 5014536 05/25/06 Effexor X X X Depression Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Neonatal Disorder, Neonatal Tachypnoea
2 Days 6090157 5060568 07/25/06 Risperdal MD Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Respiratory Disorder Neonatal
2 Days M 6104922 5071784 06/09/06 08/01/06 Fluoxetine X X Agitation Neonatal, Drug Exposure During Pregnancy, Hypoglycaemia Neonatal
2 Days M 6149212 5124721 09/01/06 10/06/06 Venlafaxine HCL X X X Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hypertonia, Nervousness, Tremor
2 Days M 6149212 5124741 09/01/06 10/06/06 Venlafaxine HCL X X X Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Nervousness
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
2 Days F 6151156 5128928 05/01/04 10/11/06 Zyprexa LW Abasia, Cerebral Haemorrhage Neonatal, Cerebrovascular Accident, Convulsion Neonatal, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Heart Rate Decreased, Foetal Movements Decreased, Hypertension Neonatal, Hypoglycaemia Neonatal, Intraventricular Haemorrhage Neonatal, Neonatal Respiratory Distress Syndrome, Tremor Neonatal
2 Days F 6160737 5142384 09/14/06 11/02/06 Lamotrigine X X CN Petit Mal Epilepsy Agitation Neonatal
2 Days F 6173814 5150822 09/14/06 11/08/06 Lamotrigine X X Petit Mal Epilepsy Agitation Neonatal, Drug Exposure During Pregnancy
66 Hours M 6031985 4973913 03/22/06 04/10/06 Effexor XR X X X Depression Drug Withdrawal Syndrome, Feeling Abnormal, Panic Attack
3 Days M 4091956 4299935 02/20/04 Tegretol X Agitation Neonatal, Drug Exposure During Pregnancy, Somnolence Neonatal
3 Days M 4128244 4284527 10/03/03 01/30/04 Prozac X X MD Agitation Neonatal, Anxiety, Foetal Arrhythmia, Irritability, Maternal Drugs Affecting Foetus, Neonatal Disorder, Sleep Disorder, Tremor Neonatal
3 Days F 5710733 4546117 10/08/04 01/05/05 Sertraline HCL X X PH Depression Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome Neonatal, Dyskinesia Neonatal, Muscle Twitching, Neonatal Disorder, Tremor Neonatal
3 Days 5881465 4772760 09/19/05 Wellbutrin X X X CN Depression Drug Exposure During Pregnancy
3 Days 5947047 4848732 08/22/05 12/06/05 Prozac X X MD Drug Exposure During Pregnancy, Somnolence Neonatal, Tremor Neonatal
3 Days 5985282 4912863 01/01/04 02/15/06 01/01/04 Tegretol X CN Drug Exposure During Pregnancy
3 Days F 6134393 5112715 02/19/05 09/22/06 Deroxat X X X CN Drug Exposure During Pregnancy, Dyskinesia, Dysphagia, Extrapyramidal Disorder, Feeding Disorder Neonatal, Hypotonia, Myoclonus, Tremor
4 Days F 4000515 4379400 04/17/02 06/17/04 Tegretol X CN Congenital Aplastic Anaemia, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
4 Days F 4084461 4290214 01/01/04 02/10/04 01/01/04 Tegretol X CN Death Neonatal, Drug Exposure During Pregnancy
4 Days M 4149832 4366953 05/06/04 05/24/04 Zoloft X X MD Depression Agitation Neonatal, Drug Exposure During Pregnancy, Fever Neonatal, Lethargy, Neonatal Disorder, Rash Neonatal
4 Days M 5796740 4654615 04/23/05 05/03/05 Lexapro X X X PH Cerebral Haemorrhage Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy, Subarachnoid Haemorrhage Neonatal, Subdural Haemorrhage Neonatal
4 Days F 5802451 4662627 03/18/05 05/12/05 Zyprexa MD Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Disorder, Respiratory Disorder Neonatal, Tremor Neonatal
4 Days F 5988305 4917673 01/01/06 02/21/06 Tegretol X Agitation Neonatal, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Fever Neonatal, Hypertonia Neonatal, Neonatal Tachypnoea
4 Days F 6028166 4998520 01/01/05 05/08/06 Zoloft X X MD Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Muscle Spasms, Myoclonus
4 Days F 6028166 4999954 01/01/05 05/01/06 Zoloft X X MD Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Muscle Spasms, Myoclonus
5 Days F 4149202 4370196 06/03/04 Abilify OT Nervousness
5 Days M 5756356 4597792 11/26/04 03/01/05 12/01/04 Anafranil X X Congenital Acrochordon, Congenital Anomaly, Congenital Hydrocephalus, Deafness Congenital, Drug Exposure During Pregnancy
5 Days M 5879880 4766206 09/09/05 Paxil X X X Chills, Crying, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Irritability, Neonatal Disorder
5 Days M 6075656 5031059 06/15/06 Fluoxetine X X Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Feeling Jittery, Hypertonia Neonatal, Hypothermia Neonatal, Hypotonia Neonatal, Irritability, Myoclonus, Restlessness, Tardive Dyskinesia
5 Days M 6220152 5178811 10/06/06 12/08/06 Zoloft X X MD Drug Exposure During Pregnancy, Jaundice Neonatal, Neonatal Disorder, Retching
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
6 Days 5840481 4718348 07/20/05 Topamax MD Drug Use for Unknown Indication Convulsion
6 Days M 5855075 4738409 07/22/05 08/09/05 Lamictal X X MD Epilepsy Crying, Drug Exposure During Pregnancy, Neonatal Disorder, Sepsis Neonatal
6 Days F 6104156 5070065 07/31/06 Atarax Cholestasis of Pregnancy Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Hypotonia Neonatal, Neonatal Oversedation
6 Days F 6153170 5134652 03/22/05 10/25/06 Lamictal X X CN Epilepsy Cardiac Disorder, Drug Exposure During Pregnancy
1 Week 4176442 4399937 09/03/03 07/14/04 Prozac X X MD Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Tachycardia
7 Days F 4211020 4446921 07/19/04 09/08/04 Citalopram HBr X X X Drug Exposure During Pregnancy, Fever Neonatal, Neonatal Disorder
7 Days F 4211020 4544797 07/19/04 12/30/04 Citalopram HBr X X X OT Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Fever Neonatal, Neonatal Disorder, Neonatal Infection
7 Days F 4211020 4553262 07/19/04 01/13/05 Citalopram HBr X X X OT Cerebral Haemorrhage Neonatal, Congenital Hydrocephalus, Drug Exposure During Pregnancy, Fever Neonatal, Neonatal Disorder, Neonatal Infection
7 Days F 4211020 4883385 07/19/04 01/13/06 Citalopram HBr X X X Drug Exposure Before Pregnancy, Fever Neonatal, Neonatal Disorder
1 Week M 5691652 4517627 10/22/04 11/30/04 Prozac X X MD Convulsion Neonatal, Drug Exposure During Pregnancy
7 Days F 5767239 4621910 12/17/04 03/29/05 Lamictal X X CN Epilepsy Congenital Anomaly, Congenital Cerebrovascular Anomaly, Drug Exposure During Pregnancy
7 Days M 5871878 4757061 04/26/05 08/29/05 Lexapro X X X PH Depression Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Week 5922120 4822108 11/03/05 Zyprexa MD Congenital Central Nervous System Anomaly, Drug Exposure During Pregnancy, Multiple Congenital Abnormalities, Neonatal Intestinal Obstruction
7 Days M 5936959 4840097 10/29/05 11/25/05 Lexapro X X X MD Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Jaundice Neonatal, Neonatal Tachypnoea, Sepsis Neonatal
7 Days M 5936959 4869808 10/29/05 12/23/05 Lexapro X X X MD Drug Exposure During Pregnancy, Jaundice Neonatal, Neonatal Disorder, Neonatal Tachypnoea
7 Days M 5936959 4905637 10/29/05 02/03/06 Lexapro X X X MD Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Jaundice Neonatal, Neonatal Disorder, Neonatal Tachypnoea
7 Days M 5936959 4975845 10/29/05 04/11/06 Lexapro X X X MD Cerebrovascular Accident, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Foetal Disorder, Jaundice Neonatal, Neonatal Disorder, Neonatal Tachypnoea, Nervous System Disorder
1 Week M 6128713 5105593 09/15/06 Clozapine X MD Neutropenia Neonatal
8 Days M 4152895 4375801 04/12/04 06/11/04 Tegretol-XR X MD Convulsion, Drug Exposure During Pregnancy
8 Days F 4160927 4382949 11/01/03 06/17/04 Haloperidol PH Drug Exposure During Pregnancy Dyskinesia Neonatal, Maternal Drugs Affecting Foetus
8 Days M 4198710 4433423 08/24/04 Atarax OT Ill-Defined Disorder Drug Exposure During Pregnancy, Lethargy, Neonatal Disorder
8 Days F 5798070 4655820 11/28/04 05/05/05 Zyprexa MD Drug Exposure During Pregnancy
8 Days F 5975017 4898924 01/01/05 02/02/06 Clozaril X Drug Exposure During Pregnancy
8 Days F 5975017 4899935 01/01/05 02/03/06 Clozaril X Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
8 Days F 6135959 5106122 01/01/05 09/11/06 Effexor XR X X X MD Anxiety, Depression, Panic Disorder Cerebrovascular Accident, Convulsion Neonatal, Crying, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hypokinesia Neonatal, Neonatal Anoxia, Neonatal Disorder, Neonatal Respiratory Arrest
10 Days M 5691652 4539544 10/22/04 12/22/04 Prozac X X MD Convulsion Neonatal, Drug Exposure During Pregnancy
10 Days F 6108760 5081814 06/01/06 08/16/06 Paxil X X X MD Anxiety Disorder Abdominal Distension, Congenital Megacolon, Drug Exposure During Pregnancy, Jaundice Neonatal
11 Days M 5750576 4590318 02/07/05 02/17/05 Lexapro X X X CN Postpartum Depression Drug Exposure Via Breast Milk, Somnolence Neonatal
11 Days M 5750576 4610313 02/07/05 03/14/05 Lexapro X X X CN Postpartum Depression Drug Exposure Via Breast Milk, Somnolence Neonatal
12 Days M 5664881 4466398 01/01/04 09/30/04 Zoloft X X Anxiety Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Heart Rate Increased, Insomnia, Muscle Twitching, Neonatal Disorder
13 Days F 5785166 4641079 03/15/05 04/19/05 03/28/05 Zoloft X X CN Congenital Anomaly, Drug Exposure During Pregnancy, Dysphagia, Neonatal Disorder, Nervous System Disorder, Pulmonary Oedema Neonatal
14 Days F 3727869 4652906 05/03/05 Lamictal X X MD Anxiety, Congenital Anomaly, Drug Exposure During Pregnancy, Neonatal Disorder, Weight Decreased
2 Weeks M 5956289 4874142 01/01/05 01/06/06 11/08/05 Paroxetine HCL X X X CN Depression Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk
15 Days 4062075 4264546 01/02/04 Lorazepam Injury Coma
16 Days Unk 6135107 5104628 03/25/06 09/11/06 Zyprexa MD Drug Exposure During Pregnancy
17 Days M 5942095 4854762 11/26/05 12/15/05 Paroxetine HCL X X X CN Drug Use for Unknown Indication Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
17 Days M 5956289 4988534 01/01/05 05/02/06 11/08/05 Paxil X X X OT Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk
3 Weeks F 5976199 4893232 07/07/05 01/24/06 Paroxetine X X X MD Dysthymic Disorder Drug Exposure During Pregnancy, Haemangioma Congenital
3 Weeks 6075799 5040726 07/03/06 Tegretol X PH Drug Exposure Via Breast Milk, Poor Weight Gain Neonatal
3 Weeks 6075799 5086235 08/23/06 Tegretol X PH Drug Exposure Via Breast Milk, Poor Weight Gain Neonatal
3 Weeks F 6126852 5109714 04/24/06 09/18/06 05/15/06 Zyprexa Zydis MD Death Neonatal, Drug Exposure During Pregnancy
3 Weeks F 6173309 5120432 04/24/06 10/02/06 05/15/06 Zyprexa Zydis Death Neonatal, Drug Exposure During Pregnancy
3 Weeks F 6173309 5157062 01/01/06 11/27/06 05/15/06 Zyprexa Zydis MD Drug Exposure During Pregnancy, Maternal Use of Illicit Drugs, Neonatal Respiratory Distress Syndrome
3 Weeks F 6200481 5189053 09/05/06 12/21/06 Prozac X X MD Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Vomiting Neonatal
4 Weeks F 5675913 4503386 09/01/04 11/17/04 Lamictal X X MD Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Fatigue, Hypersomnia, Weight Decreased
4 Weeks F 5675913 4841316 09/01/04 11/30/05 Lamictal X X MD Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Fatigue, Hypersomnia, Weight Decreased
4 Weeks M 5852078 4734730 06/27/05 08/04/05 Paxil X X X CN Depression Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Hypotonia
4 Weeks M 5935248 4844664 12/05/05 Clonidine Perioperative Analgesia Bradycardia
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
4 Weeks M 5998827 4920047 01/01/05 02/16/06 Clonidine MD Perioperative Analgesia Anaesthetic Complication Neonatal, Bradycardia Neonatal, Neonatal Respiratory Depression
29 Days M 5714200 4546400 12/21/04 01/03/05 Ziprasidone MD Schizophrenia Extrapyramidal Disorder, Neuroleptic Malignant Syndrome, Pyrexia
1 Month M 4044891 4363001 09/11/03 05/18/04 Depakene X CN Convulsion Neonatal General Physical Health Deterioration, Neonatal Disorder, Neonatal Infection
1 Month M 4168168 4414118 12/11/03 08/03/04 Abilify MD Drug Exposure During Pregnancy, Neonatal Disorder
1 Month M 4176947 4408878 12/01/02 07/27/04 Lamictal X X MD Drug Exposure During Pregnancy
1 Month M 5770046 4626710 04/05/05 Epilim X Congenital Hand Malformation, Congenital Musculoskeletal Anomaly, Congenital Nail Disorder, Congenital Nose Malformation, Foetal Valproate Syndrome
1 Month M 5778816 4633922 04/07/05 Valproate Sodium X PH Congenital Anomaly, Congenital Eye Disorder, Congenital Hand Malformation, Congenital Nail Disorder, Congenital Nose Malformation, Drug Exposure During Pregnancy, Foetal Valproate Syndrome
1 Month M 5864017 4743874 01/01/04 08/09/05 Xanax MD Ill-Defined Disorder Convulsion Neonatal, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hyperbilirubinaemia Neonatal, Hypertonia Neonatal, Hypotonia Neonatal, Neonatal Disorder, Pain, Sleep Disorder, Vomiting Neonatal, Weight Decrease Neonatal
1 Month M 5967420 4902789 02/07/06 Paxil X X X MD Drug Exposure During Pregnancy
1 Month M 5967420 4986362 04/28/06 Paxil X X X MD Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy
1 Month Unk 5988270 4903491 02/03/06 Lamictal X X Agitation Neonatal, Anorexia, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Irritability, Neonatal Disorder
1 Month M 5996682 4915681 01/01/04 02/14/06 Lexapro X X X CN Asthenia, Drug Exposure Via Breast Milk
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
1 Month M 5996682 4920050 01/01/04 02/17/06 Lexapro X X X CN Drug Exposure Via Breast Milk
1 Month M 5996682 4941894 01/01/04 03/07/06 Lexapro X X X MD Abnormal Behaviour, Drug Exposure Via Breast Milk
1 Month F 6001932 4967538 04/10/06 Paxil X X X MD Dysthymic Disorder Drug Exposure During Pregnancy
1 Month F 6001932 4975180 04/18/06 Paxil X X X MD Dysthymic Disorder Drug Exposure During Pregnancy
1 Month 6074281 5038280 05/01/06 06/29/06 Tegretol X Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Irritability
5 Weeks F 6087985 5058084 05/30/06 07/21/06 Rivotril CN Drug Use for Unknown Indication Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk
5 Weeks F 6166520 5149313 11/13/06 Paroxetine HCL X X X CN Agitation Neonatal, Congenital Anomaly, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hypoglycaemia
5 Weeks F 6180630 5159025 11/17/06 Paroxetine HCL X X X Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypoglycaemia Neonatal
5 Weeks F 6199866 5167185 11/30/06 Paroxetine HCL X X X Agitation Neonatal, Congenital Anomaly, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypoglycaemia Neonatal
6 Weeks F 4173231 4397655 06/08/04 07/13/04 Venlafaxine HCL X X X Depression Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk
6 Weeks F 4173231 4526382 06/08/04 12/10/04 Venlafaxine HCL X X X Depression Anaemia Neonatal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder
6 Weeks 4193769 4425601 08/10/04 Effexor XR X X X OT Coma
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
6 Weeks 4193769 4444459 09/02/04 Effexor XR X X X MD Loss of Consciousness
6 Weeks F 5941069 4853289 10/27/05 12/14/05 Paxil X X X CN Panic Disorder Drug Exposure During Pregnancy
44 Days M 5793080 4672442 05/24/05 Tofranil X X CN Convulsion, Drug Exposure During Pregnancy
44 Days M 5793080 4682700 06/06/05 Tofranil X X CN Agitation, Convulsion, Convulsion Neonatal, Crying, Drug Exposure During Pregnancy, Neonatal Apnoeic Attack
50 Days M 5932102 4841119 11/30/05 Abilify MD Delirium, Disorientation
8 Weeks M 4124220 4336137 03/29/04 Strattera X X PH Diarrhoea, Lethargy, Vomiting
8 Weeks M 6055707 5194497 04/29/06 12/26/06 Lexapro X X X Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome
2 Months M 5737098 4580233 01/01/04 02/14/05 Paxil X X X OT Panic Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeling Jittery, Nervous System Disorder, Tic
2 Months M 5737098 4596700 12/01/04 03/02/05 Paxil X X X OT Panic Disorder Drug Exposure During Pregnancy, Dyspnoea, Feeling Jittery, Hypothermia Neonatal, Jaundice Neonatal, Neonatal Apnoeic Attack, Neonatal Infection, Nervous System Disorder, Tic
2 Months M 5740132 4577017 01/01/04 02/08/05 Lexapro X X X OT Depression Drug Exposure Via Breast Milk, Somnolence
2 Months M 5861185 4745741 08/16/05 Floxyfral X X OT Drug Exposure During Pregnancy Agitation, Crying, Drug Withdrawal Syndrome, Hypertonia, Pain
2 Months M 5861185 4859676 01/01/05 12/19/05 Fluvoxamine Maleate X X OT Drug Exposure During Pregnancy Agitation, Crying, Drug Withdrawal Syndrome, Hypertonia, Pain
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
2 Months M 5994604 4926619 03/22/05 02/28/06 Lamictal X X CN Drug Use for Unknown Indication Drug Exposure Via Breast Milk, Insomnia, Irritability
2 Months F 5998243 4932810 07/01/05 03/06/06 Depakene X OT Drug Exposure During Pregnancy Hypotonia, Malaise
2 Months M 6017551 4960449 06/01/04 04/03/06 Paxil X X X CN Drug Exposure During Pregnancy
2 Months M 6055707 5096537 04/29/06 08/30/06 Lexapro X X X OT Depression Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Neonatal Disorder
2 Months F 6138342 5108655 05/04/06 09/15/06 05/04/06 Celexa X X X Drug Exposure During Pregnancy
10 Weeks F 5744094 4578088 05/06/04 02/09/05 Olanzapine MD Diarrhoea, Drug Exposure During Pregnancy, General Physical Health Deterioration
71 Days F 5744094 4765562 05/06/04 09/06/05 05/08/04 Olanzapine MD Diarrhoea, Drug Exposure During Pregnancy
11 Weeks F 4140998 4357137 03/18/04 05/11/04 Fluoxetine X X Depression Drug Toxicity
12 Weeks 5696383 4522542 08/16/04 12/07/04 Zyprexa MD Drug Exposure During Pregnancy
12 Weeks F 5696383 5052527 08/16/04 07/11/06 Zyprexa MD Drug Exposure During Pregnancy
12 Weeks 6157445 5138646 01/01/06 10/30/06 Lamictal X X MD Epilepsy Drug Exposure Via Breast Milk
12 Weeks 6157445 5170013 01/01/06 12/12/06 Lamictal X X MD Epilepsy Drug Exposure Via Breast Milk
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
3 Months F 4086554 4292909 07/01/03 02/12/04 Paxil X X X CN Drug Exposure Via Breast Milk
3 Months F 4086554 4295580 07/01/03 02/16/04 Paxil X X X CN Drug Exposure Via Breast Milk
3 Months F 4132490 4350044 03/01/04 04/29/04 Tegretol X OT Epilepsy Weight Increased
3 Months F 4132490 4355361 03/01/04 05/10/04 Tegretol X OT Epilepsy Nervous System Disorder, Weight Increased
3 Months M 4196638 4430558 08/18/04 Trilafon OT Depression Drug Exposure During Pregnancy, Foetal Growth Retardation, Neonatal Diabetes Mellitus
3 Months Unk 5696003 4522759 07/01/04 12/07/04 Stilnox MD Insomnia Abortion Induced, Drug Exposure During Pregnancy
3 Months F 5908579 4796826 09/16/05 Topamax PH Convulsion Convulsion
3 Months M 5932566 4841637 11/30/05 Wellbutrin XL X X X CN Drug Use for Unknown Indication Drug Exposure Via Breast Milk, Insomnia
3 Months 5934741 4837017 11/21/05 Effexor X X X Depression Congenital Anomaly, Drug Exposure During Pregnancy
3 Months 5934741 4839673 11/25/05 Effexor X X X Depression Congenital Anomaly, Drug Exposure During Pregnancy, Foetal Growth Retardation, Haemangioma Congenital
3 Months F 5980045 4905176 02/08/06 Paxil X X X CN Crying, Drug Exposure Via Breast Milk, Insomnia
3 Months M 6034570 4986128 04/28/06 Haloperidol MD Drug Use for Unknown Indication Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
3 Months F 6110505 5083838 07/01/06 08/18/06 07/04/06 Depakene X OT Epilepsy General Physical Health Deterioration, Myoclonus, Renal Failure, Shock
3 Months F 6110505 5089286 07/01/06 08/25/06 07/04/06 Depakene X OT Epilepsy General Physical Health Deterioration, Myoclonus, Renal Failure, Shock
3 Months F 6111141 5084160 08/21/06 12/30/05 Tegretol X Drug Exposure During Pregnancy, Dyspnoea, Pulmonary Artery Stenosis Congenital
3 Months F 6111141 5089724 08/28/06 12/30/05 Tegretol X Drug Exposure During Pregnancy, Dyspnoea, Pulmonary Artery Stenosis Congenital
3 Months F 6111141 5095107 09/01/06 12/30/05 Tegretol X Drug Exposure During Pregnancy, Dyspnoea, Pulmonary Artery Stenosis Congenital
3 Months M 6119363 5087239 01/01/05 08/21/06 Effexor XR X X X CN Drug Exposure Via Breast Milk
3 Months M 6119363 5096258 11/17/05 08/30/06 Effexor XR X X X Postpartum Depression Drug Exposure Via Breast Milk
3 Months M 6119363 5133047 11/17/05 10/17/06 Effexor XR X X X OT Anxiety, Postpartum Depression Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Irritability
3 Months M 6119363 5134039 11/17/05 10/19/06 Effexor XR X X X Anxiety, Postpartum Depression Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Irritability
3 Months 6150989 5127873 01/01/06 10/10/06 Effexor XR X X X Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Irritability
3 Months Ns 6150989 5129936 01/01/06 10/12/06 Effexor XR X X X Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Irritability
3 Months M 6175409 5159834 11/29/06 Wellbutrin SR X X X CN Depression Drug Exposure Via Breast Milk
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
14 Weeks F 4136907 4351330 01/01/04 04/28/04 Fluoxetine X X Drug Exposure Via Breast Milk, Somnolence
3 Months F 4144693 4363638 02/15/04 05/24/04 02/15/04 Citalopram X X X CN Depression Abnormal Behaviour, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Hypotonia, Movement Disorder, Screaming, Sedation, Somnolence
4 Months 4134785 4348465 04/01/04 04/23/04 Celexa X X X PH Drug Exposure Via Breast Milk, Maternal Drugs Affecting Foetus, Rash
4 Months 4134785 4446761 04/01/04 09/10/04 Celexa X X X PH Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Rash
4 Months F 4142585 4384413 02/01/04 06/24/04 Zyban X X X OT Abnormal Behaviour, Convulsion, Crying, Drug Toxicity, Emotional Distress, Hypotonia, Irritability, Nervous System Disorder, Restlessness
4 Months M 4177472 4404225 12/05/03 07/19/04 Mirtazapine X X X OT Depression Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Limb Hypoplasia Congenital
4 Months M 4183520 4411689 07/04/03 07/29/04 Zyprexa CN Bipolar Disorder Drug Exposure During Pregnancy, Visual Acuity Reduced
4 Months 5654928 4488925 10/29/04 Valproate Sodium X Asthenia
4 Months M 5660959 4489615 09/18/04 10/26/04 Fluoxetine X X Abdominal Pain, Drug Exposure Via Breast Milk, Irritability, Sleep Disorder
4 Months F 5675913 4536864 09/01/04 12/23/04 Lamictal X X MD Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Fatigue, Hypersomnia, Weight Decreased
4 Months F 5675913 4588180 09/01/04 02/21/05 Lamictal X X MD Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Fatigue, Hypersomnia, Weight Decreased
4 Months 5692018 4522375 12/09/04 Deroxat X X X MD Coma, Drug Toxicity
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt'd By Indications Reactions
4 Months M 5866527 4900430 01/01/05 02/01/06 07/31/05 Lexapro X X X MD Depression Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus, Neonatal Disorder, Respiratory Disorder Neonatal
4 Months M 5890907 4781149 09/23/05 Zoloft X X Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Neonatal Respiratory Distress Syndrome
4 Months M 5890907 4781593 09/27/05 Zoloft X X Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea, Neonatal Disorder, Pyrexia
4 Months F 5893604 4791754 06/07/05 10/07/05 Tegretol X MD Drug Exposure During Pregnancy, Hypoglycaemia, Hypoglycaemia Neonatal, Neonatal Respiratory Distress Syndrome
4 Months M 5961330 4881633 01/16/06 Focalin XR X Attention Deficit/Hyperactivity Disorder Drug Exposure During Pregnancy, Dyspnoea
4 Months M 5961330 4921569 09/01/05 02/24/06 Focalin XR X Attention Deficit/Hyperactivity Disorder Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea, Neonatal Disorder
4 Months 5978833 4903792 02/08/06 Paxil X X X CN Panic Disorder Drug Exposure Via Breast Milk, Rash
4 Months F 6080117 5053485 05/27/06 07/18/06 05/27/06 Topamax MD Convulsion Cardiac Arrest, Somnolence
4 Months F 6080117 5063131 05/27/06 07/27/06 05/27/06 Topamax MD Convulsion Cardiac Arrest, Somnolence
4 Months F 6116895 5090473 05/07/06 08/28/06 Wellbutrin XL X X X CN Drug Exposure Via Breast Milk
20 Weeks 5992609 4924117 02/27/06 Wellbutrin XL X X X CN Depression Drug Exposure Via Breast Milk
21 Weeks F 5652288 4476939 09/02/04 10/13/04 Olanzapine MD Convulsion, Drug Exposure During Pregnancy
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Black Box Inc'd Risk Not Appv'd Rpt