This table shows all adverse reactions and indications (the condition being treated) reported to the FDA's Adverse Event Reporting System between 2004 and 2007 where the listed psychiatric drug was identified as the Primary Suspect Drug (FDA's term) responsible for causing these reactions and where one or more of the Adverse Reactions reported for the Case described a congenital, prenatal or neonatal condition. Where no Age, Date of Event or Indication are shown, none were present in the FDA records.
The Oxford English Dictionary defines a poison as "a substance that causes death or harm when introduced into or absorbed by a living organism." These psychiatric drugs fit that definition.
Reported by: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR (Individual Safety Report)
Rpt Code is the type of report submitted: DIRect reports from Consumers or Doctor to the FDA; EXPedited reports to the FDA from GSK; PERiodic reports from GSK to the FDA.
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| F | 3793986 | 4766220 | 09/09/2005 | Paxil | Agitation Neonatal, Apathy, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypertonia Neonatal, Irritability, Lethargy, Neonatal Disorder, Premature Baby | EXP | ||||||
| F | 3794136 | 4393737 | 07/09/2004 | Paroxetine | CN | Abortion Spontaneous, Overdose | EXP | |||||
| M | 3964349 | 4766214 | 09/09/2005 | Paxil | Bleeding Time Prolonged, Blood PH Decreased, Clonus, Convulsion Neonatal, CSF Protein Increased, Drug Exposure During Pregnancy, Eye Movement Disorder, High-Pitched Crying, Hypertonia Neonatal, Lumbar Puncture Abnormal, Neonatal Disorder, Red Blood Cells CSF Positive, Subarachnoid Haemorrhage | EXP | ||||||
| F | 4003901 | 4282182 | 01/30/2004 | Paxil | CN | Anxiety | Abdominal Discomfort, Abdominal Pain Upper, Abortion Spontaneous, Aggression, Agitation, Anaemia, Anger, Anxiety, Blood Pressure Systolic Decreased, Cellulitis, Confusional State, Convulsion, Dehydration, Dependence, Dizziness, Drug Dependence, Drug Tolerance, Drug Withdrawal Syndrome, Gastroenteritis, Influenza, Insomnia, Motor Dysfunction, Nausea, Nightmare, Oedema Peripheral, Ovarian Cyst, Pharyngitis, Pharyngolaryngeal Pain, Pulmonary Congestion, Pyrexia, Rash, Sensory Disturbance, Suicidal Ideation, Throat Tightness, Tremor, Uterine Leiomyoma, Vaginitis, Viral Infection, Vision Blurred, Vomiting | EXP | ||||
| M | 4006550 | 5333652 | 06/08/2002 | 05/24/2007 | 08/21/2002 | Paxil | LW | Cardiogenic Shock, Coronary Artery Dilatation, Dilatation Ventricular, Disseminated Intravascular Coagulation, Drug Exposure During Pregnancy, Hypotension, Mitral Valve Stenosis, Premature Labour, Respiratory Distress, Sepsis, Tricuspid Valve Disease, Tricuspid Valve Incompetence | EXP | |||
| M | 4006550 | 5443342 | 06/08/2002 | 09/05/2007 | 08/21/2002 | Paxil | LW | Cardiac Failure, Cardiogenic Shock, Coronary Artery Dilatation, Dilatation Ventricular, Disseminated Intravascular Coagulation, Drug Exposure During Pregnancy, Heart Disease Congenital, Hypotension, Mitral Valve Stenosis, Premature Labour, Respiratory Distress, Sepsis, Tricuspid Valve Disease, Tricuspid Valve Incompetence | EXP | |||
| M | 4006550 | 5557523 | 06/08/2002 | 12/14/2007 | 08/21/2002 | Paxil | MD | Anxiety | Atrial Septal Defect, Bradycardia, Cardiac Failure, Cardiac Failure Congestive, Cardiac Murmur, Cardiac Valve Disease, Cardiogenic Shock, Cardiomegaly, Coagulopathy, Congenital Heart Valve Disorder, Coronary Artery Dilatation, Dilatation Ventricular, Disseminated Intravascular Coagulation, Drug Exposure During Pregnancy, Eating Disorder, Failure To Thrive, Haemodynamic Instability, Heart Disease Congenital, Hypochloraemia, Hyponatraemia, Hypotension, Metabolic Acidosis, Mitral Valve Stenosis, Multi-Organ Failure, Premature Labour, Pulmonary Hypertension, Pulmonary Hypoplasia, Pulmonary Oedema, Pyrexia, Renal Failure, Respiratory Distress, Respiratory Failure, Right Atrial Dilatation, Sepsis, Septic Shock, Supraventricular Tachycardia, Tachypnoea, Tricuspid Valve Disease, Tricuspid Valve Incompetence, White Blood Cell Count Increased | EXP | ||
| M | 4040749 | 4766221 | 09/09/2005 | Paxil | Agitation Neonatal, Alpha Haemolytic Streptococcal Infection, Apgar Score Low, Blood Sodium Decreased, Caesarean Section, C-Reactive Protein Increased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Distress Syndrome, Hypertonia Neonatal, Hypoglycaemia Neonatal, Opisthotonus, Salivary Hypersecretion | EXP | ||||||
| M | 4056679 | 4266737 | 12/06/2003 | 01/08/2004 | Paxil | MD | Apnoea, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypotonia | EXP | ||||
| M | 4056679 | 5232536 | 12/06/2003 | 02/07/2007 | Paxil | MD | Apnoea, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypotonia, Irritability, Respiratory Disorder Neonatal | EXP | ||||
| M | 4056679 | 5234443 | 12/06/2003 | 02/09/2007 | Paxil | MD | Borderline Personality Disorder | Agitation Neonatal, Apnoea, Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypotonia, Irritability, Neonatal Asphyxia, Neonatal Disorder, Respiratory Disorder Neonatal, Tremor, Vomiting | EXP | |||
| F | 4067215 | 4275509 | 01/21/2004 | Paxil CR | CN | Abortion Spontaneous | EXP | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| M | 4072534 | 4279472 | 03/01/2003 | 01/27/2004 | Deroxat | MD | Aspiration, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Foetal Distress Syndrome, Neonatal Aspiration | EXP | ||||
| 4072539 | 4279481 | 01/01/2003 | 01/27/2004 | Deroxat | MD | Drug Exposure During Pregnancy, Hypotonia, Neonatal Disorder, Tremor | EXP | |||||
| F | 4072539 | 4380602 | 01/01/2003 | 06/18/2004 | Deroxat | MD | Depression | Developmental Coordination Disorder, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypersomnia, Hypotonia, Poor Weight Gain Neonatal, Tremor | EXP | |||
| M | 4074188 | 4277001 | 01/09/2004 | Paxil | Atrophy, Convulsion Neonatal, Dilatation Ventricular, Epilepsy, Eye Movement Disorder, Fontanelle Bulging, Hypotonia, Intraventricular Haemorrhage Neonatal, Lethargy, Maternal Drugs Affecting Foetus, Neonatal Apnoeic Attack, Neonatal Disorder, Nervous System Disorder | EXP | ||||||
| M | 4075542 | 4282216 | 01/14/2004 | 01/30/2004 | Paxil | MD | Caesarean Section, Drug Exposure During Pregnancy, Respiratory Acidosis, Respiratory Depression | EXP | ||||
| M | 4075542 | 4300378 | 01/14/2004 | 02/20/2004 | Paxil | MD | Neurosis | Drug Exposure During Pregnancy, Neonatal Respiratory Acidosis, Neonatal Respiratory Depression, Respiratory Depression | EXP | |||
| M | 4075542 | 4334495 | 01/14/2004 | 04/07/2004 | Paxil | MD | Neurosis | Caesarean Section, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus, Neonatal Respiratory Depression, Respiratory Acidosis, Respiratory Depression | EXP | |||
| 4075543 | 4282217 | 01/30/2004 | Deroxat | CN | Depression | Drug Exposure During Pregnancy, Heart Disease Congenital | EXP | |||||
| 4075543 | 4284155 | 02/03/2004 | Deroxat | CN | Depression | Drug Exposure During Pregnancy, Heart Disease Congenital | EXP | |||||
| 4077960 | 4283575 | 06/18/2001 | 02/02/2004 | Seroxat | PH | Convulsion, Convulsion Neonatal, Dilatation Ventricular, Epilepsy, Eye Movement Disorder, Fontanelle Bulging, Hypotonia, Hypotonia Neonatal, Intraventricular Haemorrhage Neonatal, Joint Hyperextension, Lethargy, Maternal Drugs Affecting Foetus, Neonatal Apnoeic Attack, Nervous System Disorder, Respiratory Disorder, Respiratory Disorder Neonatal, Visual Evoked Potentials Abnormal, Vomiting | EXP | |||||
| M | 4077963 | 4283581 | 02/02/2004 | Paroxetine | CN | Apnoea, Convulsion, Convulsion Neonatal, Dilatation Ventricular, Eye Movement Disorder, Fontanelle Bulging, Hypotonia, Hypotonia Neonatal, Intraventricular Haemorrhage, Irritability, Joint Hyperextension, Lethargy, Maternal Drugs Affecting Foetus, Neonatal Apnoeic Attack, Nervous System Disorder, Visual Evoked Potentials Abnormal | EXP | |||||
| F | 4079774 | 4285118 | 11/01/2003 | 02/04/2004 | Deroxat | CN | Abdominal Wall Anomaly, Abortion Induced, Anorectal Disorder, Chromosome Abnormality, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Urinary Tract Malformation | EXP | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| F | 4079774 | 4286742 | 11/01/2003 | 02/06/2004 | Deroxat | CN | Abdominal Wall Anomaly, Abortion Induced, Anorectal Disorder, Bladder Disorder, Chromosome Abnormality, Congenital Anomaly, Drug Exposure During Pregnancy, Urinary Tract Malformation | EXP | ||||
| F | 4079774 | 4288616 | 11/01/2003 | 02/09/2004 | Deroxat | CN | Abdominal Wall Anomaly, Abortion Induced, Anorectal Disorder, Chromosome Abnormality, Congenital Bladder Anomaly, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus, Urinary Tract Malformation | EXP | ||||
| F | 4082691 | 4287464 | 06/01/2003 | 02/09/2004 | Paxil CR | PH | Postpartum Depression | Suppressed Lactation | PER | |||
| F | 4082999 | 4287793 | 09/21/2003 | 02/09/2004 | Paxil | CN | Postpartum Depression | Dizziness, Drug Withdrawal Syndrome, Headache, Photosensitivity Reaction | PER | |||
| F | 4083555 | 4288386 | 03/01/2003 | 02/09/2004 | Paxil | CN | Adverse Event | PER | ||||
| F | 4083555 | 4391411 | 03/01/2003 | 07/07/2004 | Paxil | CN | Ill-Defined Disorder | Abortion Spontaneous, Adverse Event, Arthralgia, Asthenia, Blood Disorder, Dehydration, Diarrhoea, Disturbance In Attention, Loss of Libido, Muscle Cramp, Weight Increased | EXP | |||
| F | 4084927 | 4739952 | 08/10/2005 | Paxil | CN | Postpartum Depression | Crying, Drug Withdrawal Syndrome, Emotional Disorder, Headache, Migraine, Nausea, Paraesthesia, Photophobia | PER | ||||
| F | 4085350 | 4291266 | 02/11/2004 | Paxil | CN | Postpartum Depression | Agitation, Anxiety, Dizziness, Insomnia, Nausea, Paraesthesia, Sexual Dysfunction, Vomiting | PER | ||||
| F | 4085400 | 4291316 | 09/01/2003 | 02/11/2004 | Paxil | CN | Postpartum Depression | Anxiety, Derealisation | PER | |||
| F | 4085412 | 4291329 | 02/11/2004 | Paxil | CN | Abortion Spontaneous, Drug Exposure During Pregnancy | PER | |||||
| F | 4086463 | 4292825 | 02/12/2004 | Paxil | CN | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome | PER | |||||
| F | 4086463 | 4295495 | 02/16/2004 | Paxil | CN | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome | PER | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| F | 4086463 | 4574523 | 02/08/2005 | Paxil | LW | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome | PER | |||||
| F | 4086463 | 4603917 | 01/01/1996 | 03/10/2005 | Paxil | MD | Anxiety | Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Normal Pregnancy, Scar, Umbilical Cord Around Neck | EXP | |||
| F | 4086463 | 4615118 | 01/01/1996 | 03/22/2005 | Paxil | MD | Anxiety | Caesarean Section, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Normal Pregnancy, Scar, Umbilical Cord Around Neck | EXP | |||
| F | 4095781 | 4305184 | 02/26/2004 | Paxil | LW | Drug Use for Unknown Indication | Abortion Spontaneous, Aggression, Agitation, Anxiety, Complications of Maternal Exposure To Therapeutic Drugs, Confusional State, Disability, Disturbance In Attention, Dizziness, Drug Withdrawal Syndrome, Fatigue, Headache, Lethargy, Maternal Drugs Affecting Foetus, Memory Impairment, Migraine, Nervousness, Nightmare, Paraesthesia, Performance Status Decreased, Sleep Disorder, Suicidal Ideation, Tremor | EXP | ||||
| F | 4099149 | 4308397 | 03/01/2004 | Paroxetine | CN | Bradycardia, Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Electroencephalogram Abnormal, Encephalopathy Neonatal, Hypopnoea, Hypotonia | EXP | |||||
| M | 4099617 | 4309147 | 03/02/2004 | Paxil | LW | Drug Use for Unknown Indication | Abortion Spontaneous, Aggression, Agitation, Disability, Dizziness, Drug Withdrawal Syndrome, Nausea, Paraesthesia, Performance Status Decreased, Suicidal Ideation, Tremor, Vertigo, Vomiting | EXP | ||||
| F | 4099661 | 4309223 | 03/02/2004 | Paxil | LW | Drug Use for Unknown Indication | Abdominal Pain, Abortion Spontaneous, Aggression, Agitation, Asthenia, Disability, Disturbance In Attention, Drug Withdrawal Syndrome, Fatigue, Hyperhidrosis, Influenza, Memory Impairment, Nausea, Nightmare, Performance Status Decreased, Sleep Disorder, Vomiting | EXP | ||||
| F | 4099698 | 4309280 | 03/02/2004 | Paxil | LW | Drug Use for Unknown Indication | Aggression, Agitation, Anxiety, Confusional State, Disturbance In Attention, Dizziness, Drug Withdrawal Syndrome, Fatigue, Headache, Hyperhidrosis, Lethargy, Memory Impairment, Migraine, Nausea, Nervousness, Nightmare, Paraesthesia, Sleep Disorder, Suicidal Ideation, Tremor, Vertigo, Vomiting | EXP | ||||
| F | 4099700 | 4309284 | 03/02/2004 | Paxil | LW | Drug Use for Unknown Indication | Abdominal Pain, Abortion Spontaneous, Aggression, Agitation, Anxiety, Asthenia, Confusional State, Diarrhoea, Disturbance In Attention, Dizziness, Drug Withdrawal Syndrome, Fatigue, Headache, Hyperhidrosis, Influenza, Lethargy, Memory Impairment, Migraine, Nervousness, Nightmare, Paraesthesia, Performance Status Decreased, Sleep Disorder, Tremor, Vertigo | EXP | ||||
| F | 4099708 | 4309291 | 03/02/2004 | Paxil | LW | Drug Use for Unknown Indication | Abdominal Pain, Abortion Spontaneous, Aggression, Agitation, Anxiety, Asthenia, Confusional State, Diarrhoea, Disability, Disturbance In Attention, Dizziness, Drug Withdrawal Syndrome, Fatigue, Headache, Hyperhidrosis, Influenza, Lethargy, Memory Impairment, Migraine, Nausea, Nervousness, Nightmare, Performance Status Decreased, Self Mutilation, Sleep Disorder, Suicidal Ideation, Vertigo, Vomiting | EXP | ||||
| 4101620 | 4312322 | 10/17/2000 | 03/05/2004 | Deroxat | CN | Depression | Cardiac Failure, Circulatory Failure Neonatal, Cystic Fibrosis Pancreatic, Drug Exposure During Pregnancy, Encephalopathy, Encephalopathy Neonatal, Enterocolitis, Facial Dysmorphism, Mitral Valve Incompetence, Neonatal Cardiac Failure, Neonatal Hypotension, Premature Baby, Renal Failure Acute, Renal Failure Neonatal | EXP | ||||
| M | 4102558 | 4313537 | 01/28/2004 | 03/08/2004 | Paxil | MD | Neonatal Tachypnoea, Tremor | EXP | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| M | 4102558 | 4317957 | 01/28/2004 | 03/16/2004 | Paxil | MD | Congenital Atrial Septal Defect, Cyanosis, Cyanosis Neonatal, Drug Withdrawal Syndrome Neonatal, Ill-Defined Disorder, Intercostal Retraction, Maternal Drugs Affecting Foetus, Micrognathia, Muscle Rigidity, Neonatal Asphyxia, Neonatal Tachypnoea, Respiratory Acidosis, Tremor, Tremor Neonatal | EXP | ||||
| M | 4102558 | 4322094 | 01/28/2004 | 03/23/2004 | Paxil | MD | Congenital Atrial Septal Defect, Cyanosis, Foetal Valproate Syndrome, Intercostal Retraction, Irritability, Maternal Drugs Affecting Foetus, Micrognathia, Muscle Rigidity, Neonatal Asphyxia, Neonatal Tachypnoea, Respiratory Acidosis, Tremor, Tricuspid Valve Incompetence | EXP | ||||
| M | 4102558 | 4328191 | 01/28/2004 | 03/31/2004 | Paxil | MD | Apgar Score Low, Asphyxia, Congenital Atrial Septal Defect, Cyanosis, Drug Withdrawal Syndrome, Hypertonia, Intercostal Retraction, Irritability, Maternal Drugs Affecting Foetus, Micrognathia, Neonatal Asphyxia, Neonatal Tachypnoea, Nervous System Disorder, Respiratory Acidosis, Tremor, Tricuspid Valve Incompetence | EXP | ||||
| 4103141 | 4314395 | 01/01/2004 | 03/09/2004 | Paxil CR | CN | Drug Use for Unknown Indication | Convulsion, Depressed Level of Consciousness, Drug Exposure During Pregnancy | EXP | ||||
| 4103141 | 4327133 | 01/01/2004 | 03/30/2004 | Paxil CR | CN | Generalised Anxiety Disorder | Coma Neonatal, Convulsion, Convulsion Neonatal, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Grand Mal Convulsion | EXP | ||||
| F | 4103564 | 4311526 | 02/14/2004 | 03/03/2004 | Paxil | CN | Postpartum Depression | Drug Withdrawal Syndrome, Headache, Nightmare, Paraesthesia, Vertigo, Vomiting | DIR | |||
| F | 4107867 | 4317639 | 03/15/2004 | Paxil | CN | Congenital Anomaly, Drug Exposure During Pregnancy | EXP | |||||
| F | 4113493 | 4323406 | 02/19/2004 | 03/25/2004 | Paroxetine | PH | Drug Abuser, Drug Exposure During Pregnancy | EXP | ||||
| F | 4113493 | 4336672 | 02/19/2004 | 04/12/2004 | Paroxetine | PH | Complications of Maternal Exposure To Therapeutic Drugs, Drug Abuser, Drug Exposure During Pregnancy | EXP | ||||
| M | 4114645 | 4324810 | 03/02/2004 | 03/26/2004 | Deroxat | CN | Depression | Agitation, Disturbance In Attention, Drug Exposure During Pregnancy, Dyskinesia, Electroencephalogram Abnormal, Hypertonia, Hypotonia Neonatal, Oculogyration, Sleep Disorder, Tremor Neonatal | EXP | |||
| F | 4115281 | 4323335 | 03/24/2004 | Paxil | CN | Abortion Spontaneous, Anger, Anxiety, Crying, Depression, Drug Dependence, Drug Withdrawal Syndrome, Feeling Abnormal, Migraine, Movement Disorder, Panic Attack, Pregnancy, Self-Injurious Ideation, Suicidal Ideation | DIR | |||||
| F | 4116474 | 4324665 | 03/25/2004 | Paxil | CN | Panic Attack | Complications of Maternal Exposure To Therapeutic Drugs, Depression, Feeling of Despair, Post-Traumatic Stress Disorder, Pregnancy, Self-Injurious Ideation | DIR | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| F | 4127239 | 4338039 | 04/07/2004 | Paxil | Blood Lactic Acid Increased, Bradycardia Neonatal, Clonus, Convulsion Neonatal, Cyanosis Neonatal, Drug Withdrawal Syndrome Neonatal, Hypertonia, Hypopnoea, Hypotonia, Maternal Drugs Affecting Foetus | EXP | ||||||
| F | 4127239 | 4766207 | 09/09/2005 | Paxil | Blood Lactic Acid Increased, Blood PH Decreased, Bradycardia Neonatal, Carbon Dioxide Increased, Clonus, Convulsion Neonatal, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Electroencephalogram Abnormal, Hypertonia Neonatal, Hypopnoea, Hypotonia Neonatal, Neonatal Disorder | EXP | ||||||
| F | 4147902 | 4366015 | 05/25/2004 | 05/26/2004 | Paxil | CN | Anxiety, Postpartum Depression | Abnormal Dreams, Aggression, Disturbance In Attention, Drug Withdrawal Syndrome, Emotional Disorder, Flat Affect, Hyperhidrosis, Indifference, Irritability, Lethargy, Myalgia, Nervous System Disorder, Paraesthesia, Suicidal Ideation, Weight Increased | DIR | |||
| F | 4148180 | 4365356 | 05/25/2004 | Paxil | Agitation, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Disorder, Neonatal Respiratory Distress Syndrome | EXP | ||||||
| F | 4166129 | 4404186 | 07/19/2004 | Paroxetine | CN | Anxiety, Drug Exposure During Pregnancy | Bradycardia Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy, Electroencephalogram Abnormal, Hypopnoea, Hypotonia Neonatal, Respiratory Disorder Neonatal | EXP | ||||
| 4167763 | 4396310 | 07/13/2004 | Seroxat | PH | Drug Use for Unknown Indication | Cerebrovascular Accident, Convulsion, Drug Exposure During Pregnancy | EXP | |||||
| F | 4167763 | 4421011 | 06/29/2004 | 08/09/2004 | Paroxetine | PH | Depression | Cerebrovascular Accident, Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy, Nervous System Disorder | EXP | |||
| 4169493 | 4399522 | 07/16/2004 | Paxil | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | EXP | |||||
| 4169493 | 4415220 | 03/26/2004 | 08/04/2004 | Paxil | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | EXP | ||||
| 4177456 | 4409929 | 07/28/2004 | Paroxetine | CN | Ill-Defined Disorder | Drug Exposure During Pregnancy, Foetal Growth Retardation | EXP | |||||
| F | 4180941 | 4407228 | 01/26/2004 | 07/23/2004 | Paxil | OT | Postpartum Depression | Confusional State, Dysarthria, Feeling Abnormal, Feeling Jittery, Headache, Insomnia, Nausea, Nervousness | DIR | |||
| F | 4181710 | 4415240 | 07/14/2004 | 08/04/2004 | Paxil | MD | Drug Exposure During Pregnancy, Feeding Problem In Newborn, Hypothermia | EXP | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| F | 4181710 | 4426823 | 07/14/2004 | 08/16/2004 | Paxil | MD | Drug Exposure During Pregnancy, Feeding Problem In Newborn, Hypothermia | EXP | ||||
| F | 4181710 | 4449933 | 07/14/2004 | 09/15/2004 | Paxil | MD | Drug Exposure During Pregnancy, Feeding Problem In Newborn, Hypothermia, Hypothermia Neonatal, Poor Sucking Reflex | EXP | ||||
| F | 4182652 | 4409822 | 11/18/2003 | 07/27/2004 | Paxil | CN | Depression, Postpartum Depression | Impulsive Behaviour, Pyromania | DIR | |||
| F | 4184612 | 4418270 | 08/09/2004 | Paxil CR | CN | Postpartum Depression | Anxiety, Nervousness | PER | ||||
| F | 4185882 | 4419530 | 08/09/2004 | Paxil | CN | Ill-Defined Disorder | Drug Withdrawal Syndrome | PER | ||||
| F | 4186499 | 4420227 | 08/09/2004 | Paxil | CN | Drug Use for Unknown Indication | Drug Withdrawal Syndrome | PER | ||||
| F | 4186847 | 4740083 | 08/27/2002 | 08/10/2005 | Paxil | MD | Postpartum Depression | Confusional State, Dependence, Dizziness, Drug Withdrawal Syndrome, Hot Flush, Hyperhidrosis, Paraesthesia, Peripheral Sensory Neuropathy | PER | |||
| F | 4187052 | 4420809 | 08/09/2004 | Paxil | OT | Postpartum Depression | Drug Withdrawal Syndrome, Fatigue, Mood Swings, Myalgia, Neurological Symptom, Sleep Disorder | PER | ||||
| F | 4187069 | 4420826 | 08/09/2004 | Paxil | CN | Postpartum Depression | Agitation, Dizziness, Nausea | PER | ||||
| 4213357 | 4455978 | 09/06/2004 | 09/22/2004 | Paxil | PH | Hypertonia, Respiratory Acidosis, Respiratory Depression | EXP | |||||
| 4213357 | 4463249 | 09/06/2004 | 09/30/2004 | Paxil | PH | Drug Exposure During Pregnancy, Hypotonia, Hypotonia Neonatal, Neonatal Disorder, Neonatal Respiratory Acidosis, Neonatal Respiratory Depression, Premature Baby, Respiratory Acidosis, Respiratory Depression | EXP | |||||
| F | 4213357 | 4489955 | 09/06/2004 | 11/01/2004 | Paxil | PH | Drug Exposure During Pregnancy, Hypotonia, Respiratory Acidosis, Respiratory Depression | EXP | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| M | 4219264 | 4463268 | 06/29/2004 | 09/30/2004 | Paroxetine | CN | Areflexia, Bradycardia, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Respiratory Depression, Pallor, Restlessness | EXP | ||||
| M | 4219264 | 4466336 | 06/29/2004 | 10/05/2004 | Paroxetine | CN | Abnormal Faeces, Bradycardia, Bradycardia Neonatal, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder, Neonatal Respiratory Depression, Pallor, Premature Baby, Restlessness, Tremor, Tremor Neonatal | EXP | ||||
| M | 4219271 | 4463275 | 06/29/2004 | 09/30/2004 | Paroxetine | CN | Areflexia, Bradycardia, Bradycardia Neonatal, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Respiratory Depression, Pallor, Restlessness | EXP | ||||
| M | 4219271 | 4466340 | 06/29/2004 | 10/05/2004 | Paroxetine | CN | Areflexia, Bradycardia, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Apnoeic Attack, Neonatal Respiratory Depression, Oxygen Saturation Decreased, Pallor, Premature Baby, Restlessness, Unresponsive To Pain Stimuli | EXP | ||||
| F | 4220100 | 4464221 | 08/04/2004 | 10/01/2004 | Deroxat | CN | Agitation, Drug Exposure During Pregnancy, High-Pitched Crying, Hypertonia, Respiratory Distress, Somnolence Neonatal, Tachypnoea, Tremor | EXP | ||||
| F | 4220100 | 4554759 | 08/04/2004 | 01/18/2005 | Deroxat | CN | Agitation, Apgar Score Low, Apnoeic Attack, Chest X-Ray Abnormal, Drug Exposure During Pregnancy, High-Pitched Crying, Hypertonia, Neonatal Respiratory Distress Syndrome, Respiratory Distress, Somnolence Neonatal, Tachypnoea, Tremor | EXP | ||||
| F | 5654406 | 4488092 | 03/23/2004 | 10/28/2004 | Paroxetine | MD | Depression | Cytomegalovirus Infection, Drug Exposure During Pregnancy, Intra-Uterine Death | EXP | |||
| F | 5670527 | 4477489 | 10/18/2004 | Paxil | CN | Ill-Defined Disorder | Congenital Eye Disorder, Drug Exposure During Pregnancy | EXP | ||||
| M | 5671641 | 4482475 | 08/27/2004 | 10/22/2004 | Paroxetine | CN | Drug Use for Unknown Indication | Blepharophimosis, Congenital Hyperextension of Spine, Drug Exposure During Pregnancy, Ear Malformation, Facial Dysmorphism, Hypertelorism of Orbit, Hypertonia, Irritability, Neck Deformity | EXP | |||
| F | 5674212 | 4502320 | 11/16/2004 | 03/16/2004 | Aropax | MD | Cerebral Haemorrhage, Cytomegalovirus Infection, Foetal Growth Retardation, Placental Disorder | EXP | ||||
| F | 5677772 | 4505736 | 11/19/2004 | Paxil | CN | Panic Disorder | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Malaise, Premature Labour | EXP | ||||
| F | 5677773 | 4505737 | 11/19/2004 | Paxil | CN | Panic Disorder | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Malaise, Premature Labour | EXP | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| F | 5686669 | 4515215 | 12/01/2004 | Seroxat | CN | Postpartum Depression | Amnesia, Dependence, Depression, Dissociation, Drug Withdrawal Syndrome, Emotional Disorder, Fatigue, Lethargy, Mental Disorder, Physical Abuse, Psychomotor Hyperactivity | EXP | ||||
| M | 5692010 | 4522365 | 08/29/2004 | 12/09/2004 | Deroxat | CN | Depression | Drug Exposure During Pregnancy, Dyskinesia, Foetal Growth Retardation, Hyperventilation, Hypoxia, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Pregnancy, Tremor | EXP | |||
| F | 5696712 | 4715996 | 05/07/2003 | 07/18/2005 | Seroxat | MD | Postpartum Depression | Alcohol Use, Completed Suicide, Drug Withdrawal Syndrome, Ill-Defined Disorder, Irritability, Suicidal Ideation | EXP | |||
| F | 5696819 | 4529173 | 12/16/2004 | Seroxat | LW | Completed Suicide, Emotional Disorder, Ill-Defined Disorder | EXP | |||||
| F | 5696819 | 4646722 | 11/01/2001 | 04/27/2005 | Seroxat | MD | Abortion Spontaneous, Drug Exposure During Pregnancy, Drug Intolerance, Ill-Defined Disorder, Overdose, Pregnancy, Suicide Attempt | EXP | ||||
| F | 5696819 | 5230741 | 11/01/2001 | 02/06/2007 | Seroxat | MD | Abortion Spontaneous, Drug Withdrawal Syndrome, Overdose, Suicide Attempt | EXP | ||||
| F | 5709805 | 4541047 | 12/28/2004 | Paxil | Caesarean Section, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Gene Mutation Identification Test Positive, Hypoglycaemia Neonatal, Hypotonia Neonatal, Loose Stools, Meconium In Amniotic Fluid, Muscle Rigidity, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Serum Serotonin Increased, Tremor Neonatal | EXP | ||||||
| M | 5711906 | 4543962 | 01/03/2005 | Paroxetine | MD | Cerebral Atrophy Congenital, Cerebral Ventricle Dilatation, Congenital Neurological Disorder, Drug Exposure During Pregnancy, Epilepsy Congenital, Eye Movement Disorder, Fontanelle Bulging, Hypotonia Neonatal, Intraventricular Haemorrhage Neonatal, Lethargy, Neonatal Apnoeic Attack, Neonatal Disorder, Serum Serotonin Decreased, Stereotypic Movement Disorder, Visual Evoked Potentials Abnormal | EXP | |||||
| F | 5717961 | 4556050 | 12/27/2004 | 01/19/2005 | Deroxat | CN | Drug Exposure During Pregnancy, Hypotonia, Hypotonia Neonatal, Neonatal Apnoeic Attack, Pregnancy | EXP | ||||
| F | 5717961 | 4608834 | 12/27/2004 | 03/15/2005 | Deroxat | CN | Drug Exposure During Pregnancy, Hypotonia, Hypotonia Neonatal, Hypoventilation, Hypoventilation Neonatal, Neonatal Apnoeic Attack, Pregnancy | EXP | ||||
| 5721077 | 4559543 | 01/01/2005 | 01/24/2005 | Seroxat | MD | Congenital Bladder Anomaly, Drug Exposure During Pregnancy, Gastrointestinal Disorder Congenital, Gastrointestinal Motility Disorder | EXP | |||||
| 5721077 | 4562813 | 11/05/2004 | 01/27/2005 | Seroxat | MD | Congenital Bladder Anomaly, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Gastrointestinal Disorder Congenital, Gastrointestinal Malformation, Gastrointestinal Motility Disorder | EXP | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| 5721077 | 4617849 | 11/05/2004 | 03/24/2005 | Paroxetine | MD | Congenital Bladder Anomaly, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Gastrointestinal Disorder Congenital, Gastrointestinal Malformation, Gastrointestinal Motility Disorder | EXP | |||||
| 5722373 | 4555636 | 01/18/2005 | Paroxetine | MD | Drug Exposure During Pregnancy, Kidney Malformation, Renal Agenesis, Ultrasound Antenatal Screen Abnormal, Urinary Tract Malformation | EXP | ||||||
| 5722373 | 4562770 | 01/21/2005 | Paroxetine | MD | Congenital Anomaly, Drug Exposure During Pregnancy, Kidney Malformation, Single Functional Kidney, Urinary Tract Malformation | EXP | ||||||
| 5722373 | 4562899 | 01/21/2005 | Paroxetine | MD | Congenital Genitourinary Abnormality, Drug Exposure During Pregnancy, Kidney Malformation, Single Functional Kidney, Urinary Tract Malformation | EXP | ||||||
| F | 5728405 | 4568289 | 01/01/2005 | 02/02/2005 | Paxil | CN | Drug Use for Unknown Indication | Abortion Spontaneous | EXP | |||
| M | 5737099 | 4580234 | 01/01/2005 | 02/14/2005 | Paxil | OT | Depression | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Pneumothorax | EXP | |||
| M | 5742120 | 4587263 | 02/18/2005 | Paroxetine | CN | Depression | Anomaly of External Ear Congenital, Cataract, Chondrodystrophy, Congenital Musculoskeletal Anomaly, Cyanosis, Drug Exposure During Pregnancy, Facial Dysmorphism, Neck Deformity, Respiratory Arrest | EXP | ||||
| M | 5767845 | 4622852 | 03/30/2005 | Paxil | MD | Panic Disorder | Drug Exposure During Pregnancy, Jaundice Neonatal | EXP | ||||
| M | 5770385 | 4627133 | 01/01/2001 | 04/05/2005 | Paxil | CN | Congenital Absence of Bile Ducts, Drug Exposure During Pregnancy | EXP | ||||
| F | 5774750 | 4634085 | 04/13/2005 | Paxil CR | CN | Abortion Spontaneous, Drug Exposure During Pregnancy | EXP | |||||
| F | 5781777 | 4644176 | 04/01/2005 | 04/25/2005 | Paroxetine | MD | Conjunctival Haemorrhage, Dermatitis Diaper, Diarrhoea Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Exanthem, Hypokinesia, Oblique Presentation, Oligodipsia, Polycythaemia, Somnolence Neonatal, Vomiting Neonatal, Weight Decreased | EXP | ||||
| F | 5787633 | 4651837 | 05/04/2005 | Paxil CR | CN | Congenital Anomaly, Drug Exposure During Pregnancy | EXP | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| M | 5787633 | 4682631 | 01/01/2005 | 06/06/2005 | Paxil CR | CN | Congenital Anomaly, Congenital Ureteric Anomaly, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hydronephrosis, Kidney Malformation | EXP | ||||
| F | 5801937 | 4668968 | 01/01/2004 | 05/23/2005 | Paroxetine | MD | Abortion Induced, Asthenia, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Abnormal, Hyperemesis Gravidarum, Malaise, Pregnancy | EXP | ||||
| F | 5814227 | 4685399 | 06/08/2005 | Deroxat | CN | Abortion Induced, Congenital Nose Malformation, Drug Exposure During Pregnancy, Facial Dysmorphism, Micrognathia, Multiple Congenital Abnormalities, Oesophageal Atresia, Retrognathia | EXP | |||||
| F | 5815063 | 4679396 | 05/31/2005 | Paxil | MD | Abortion Spontaneous, Agitation, Anorexia, Anxiety, Apathy, Contusion, Depressed Mood, Depression, Drug Exposure During Pregnancy, Drug Ineffective, Drug Withdrawal Syndrome, Dysphagia, Dyspnoea, Economic Problem, Feeling Abnormal, Flushing, Food Craving, Heart Rate Increased, Hyperventilation, Insomnia, Lethargy, Nausea, Night Sweats, Panic Attack, Paraesthesia, Restlessness, Suicidal Ideation, Tearfulness | EXP | |||||
| F | 5816453 | 4687912 | 06/10/2005 | Paxil | CN | Stillbirth | EXP | |||||
| 5817453 | 4688819 | 06/13/2005 | Paxil | CN | Ventricular Septal Defect | EXP | ||||||
| 5819180 | 4690656 | 02/24/2005 | 06/15/2005 | 02/24/2005 | Deroxat | CN | Drug Exposure During Pregnancy, Intra-Uterine Death | EXP | ||||
| 5820565 | 4692727 | 01/01/2005 | 06/17/2005 | 05/10/2005 | Paxil CR | CN | Drug Exposure During Pregnancy, Foetal Growth Retardation | EXP | ||||
| Unk | 5824757 | 4690908 | 06/10/2005 | Paroxetine | Antidepressant Drug Level Increased, Drug Exposure During Pregnancy, Hypertonia Neonatal | EXP | ||||||
| F | 5825255 | 4699310 | 10/01/2001 | 06/24/2005 | Paroxetine | MD | Abortion Spontaneous, Agitation, Anxiety, Apathy, Decreased Appetite, Depressed Mood, Depression, Drug Withdrawal Syndrome, Dysphagia, Dyspnoea, Flushing, Heart Rate Increased, Hyperventilation, Nausea, Night Sweats, Panic Attack, Paraesthesia, Restlessness, Sleep Disorder, Suicidal Ideation, Tearfulness | EXP | ||||
| M | 5825264 | 4699327 | 06/24/2005 | Paroxetine | CN | Drug Exposure During Pregnancy, Feeding Problem In Newborn, Hypoglycaemia, Hypoglycaemia Neonatal, Hypotonia, Hypotonia Neonatal, Lethargy, Motor Dysfunction, Respiratory Depth Decreased | EXP | |||||
| 5829518 | 4705390 | 06/27/2005 | 07/01/2005 | 06/27/2005 | Paxil | CN | Amniotic Fluid Volume Decreased, Congenital Genitourinary Abnormality, Drug Exposure During Pregnancy, Renal Cyst | EXP | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| F | 5829518 | 4735618 | 06/27/2005 | 08/05/2005 | 06/27/2005 | Paxil | CN | Generalised Anxiety Disorder | Abortion Induced, Amniotic Fluid Volume Decreased, Congenital Genitourinary Abnormality, Drug Exposure During Pregnancy, Renal Cyst | EXP | ||
| M | 5829521 | 4705393 | 06/29/2005 | 07/01/2005 | Paroxetine | CN | Depression | Drug Exposure During Pregnancy, Limb Malformation, Pharmaceutical Product Complaint | EXP | |||
| M | 5829521 | 4710839 | 06/29/2005 | 07/11/2005 | Paroxetine | CN | Depression | Congenital Anomaly, Drug Exposure During Pregnancy, Limb Malformation, Pharmaceutical Product Complaint | EXP | |||
| M | 5829521 | 4715985 | 06/29/2005 | 07/18/2005 | Paroxetine | CN | Depression | Limb Malformation, Pharmaceutical Product Complaint | EXP | |||
| F | 5830390 | 4706464 | 02/11/2005 | 07/05/2005 | Deroxat | MD | Panic Reaction | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Foetal Arrhythmia, Premature Baby | EXP | |||
| M | 5835831 | 4707599 | 07/05/2005 | Paroxetine | Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hypoglycaemia Neonatal, Hypotonia Neonatal, Lethargy, Motor Dysfunction, Neonatal Disorder, Poor Sucking Reflex, Respiratory Disorder Neonatal | EXP | ||||||
| M | 5835831 | 4766208 | 09/09/2005 | Paxil | Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Hypoglycaemia Neonatal, Hypotonia Neonatal, Lethargy, Neonatal Disorder, Poor Sucking Reflex, Respiratory Disorder Neonatal | EXP | ||||||
| 5838037 | 4715168 | 12/07/2004 | 07/15/2005 | 06/23/2005 | Paroxetine | CN | Drug Use for Unknown Indication | Death Neonatal, Drug Exposure During Pregnancy | EXP | |||
| M | 5841906 | 4720735 | 07/14/2005 | 07/21/2005 | Paxil | MD | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome | EXP | ||||
| M | 5841906 | 4725976 | 07/14/2005 | 07/27/2005 | Paxil | MD | Caesarean Section, Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Jittery, Moaning, Somnolence, Tachypnoea | EXP | ||||
| M | 5841906 | 4762616 | 07/14/2005 | 09/07/2005 | Paxil | MD | Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeling Jittery, Moaning, Somnolence, Tachypnoea | EXP | ||||
| M | 5841906 | 4770833 | 07/14/2005 | 09/15/2005 | Paxil | MD | Caesarean Section, Convulsion, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeding Disorder Neonatal, Feeling Jittery, Moaning, Somnolence, Somnolence Neonatal, Tachypnoea | EXP | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| M | 5845596 | 4724769 | 07/17/2005 | 07/26/2005 | Paxil | MD | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome | EXP | ||||
| M | 5845596 | 4742826 | 07/17/2005 | 08/11/2005 | Paxil | MD | Cardiac Murmur, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Nausea, Oxygen Saturation Decreased, Persistent Foetal Circulation, Tremor | EXP | ||||
| M | 5845596 | 4794270 | 07/17/2005 | 10/11/2005 | Paxil | MD | Cardiac Murmur, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Irritability, Nausea, Oxygen Saturation Decreased, Persistent Foetal Circulation, Tremor | EXP | ||||
| M | 5853915 | 4736891 | 05/01/2005 | 08/08/2005 | Deroxat | CN | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hyperbilirubinaemia, Hypertonia, Hypotonia, Insomnia, Poor Weight Gain Neonatal, Tension, Vomiting | EXP | ||||
| F | 5855837 | 4739327 | 08/10/2005 | Paroxetine | CN | Postpartum Depression | Abnormal Dreams, Diarrhoea, Night Sweats, Palpitations | PER | ||||
| F | 5855912 | 4739402 | 08/10/2005 | Paxil | CN | Postpartum Depression | Drug Withdrawal Syndrome | PER | ||||
| 5855952 | 4739442 | 01/26/2005 | 08/10/2005 | Paxil | CN | Depression | Drug Exposure During Pregnancy, Premature Baby | PER | ||||
| F | 5856584 | 4740243 | 08/10/2005 | Paxil | CN | Postpartum Depression | Drug Withdrawal Syndrome, Feeling Abnormal, Malaise | PER | ||||
| 5857070 | 4740971 | 08/10/2005 | Paxil | CN | Depression | Drug Exposure During Pregnancy, Premature Labour | PER | |||||
| F | 5857208 | 4741160 | 08/10/2005 | Paxil | LW | Drug Use for Unknown Indication | Drug Withdrawal Syndrome | PER | ||||
| F | 5857208 | 4904101 | 05/24/2002 | 02/08/2006 | Paxil | LW | Anxiety | Abortion Spontaneous, Drug Withdrawal Syndrome | PER | |||
| F | 5857278 | 4741230 | 08/10/2005 | Paxil | LW | Postpartum Depression | Dizziness, Drug Withdrawal Syndrome, Headache, Nausea, Vomiting | PER | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| F | 5859359 | 4686229 | 06/09/2005 | Paxil | CN | Apgar Score Low, Drug Exposure During Pregnancy | EXP | |||||
| M | 5866751 | 4752340 | 01/27/2005 | 08/25/2005 | Paroxetine | CN | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Polyhydramnios, Poor Sucking Reflex | EXP | |||
| 5877725 | 4768719 | 10/22/2003 | 09/14/2005 | Paxil CR | CN | Depression | Drug Exposure During Pregnancy, Heart Disease Congenital | EXP | ||||
| Unk | 5879891 | 4766219 | 06/18/2001 | 09/09/2005 | Paxil | Brain Scan Abnormal, Cerebral Atrophy, Cerebral Haematoma, Cerebral Haemorrhage Neonatal, Convulsion Neonatal, Drug Exposure During Pregnancy, Eye Movement Disorder, Fontanelle Bulging, Hypotonia Neonatal, Intracranial Pressure Increased, Intraventricular Haemorrhage Neonatal, Lethargy, Moaning, Movement Disorder, Neonatal Apnoeic Attack, Neonatal Disorder, Nervous System Disorder, Pupils Unequal, Respiratory Disorder, Ventricular Hypertrophy, Vomiting Neonatal | EXP | |||||
| M | 5879897 | 4766222 | 09/09/2005 | Paxil | Agitation Neonatal, Bradycardia Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Small for Dates Baby, Vomiting Neonatal | EXP | ||||||
| F | 5879898 | 4766223 | 09/09/2005 | Paxil | Drug Exposure During Pregnancy, Intraventricular Haemorrhage Neonatal, Nervous System Disorder, Premature Baby, Subarachnoid Haemorrhage Neonatal | EXP | ||||||
| 5879943 | 4766541 | 09/09/2005 | Paxil | Drug Dispensing Error, Drug Exposure During Pregnancy, Drug Interaction, Drug Withdrawal Syndrome Neonatal, Eye Movement Disorder, Feeding Disorder Neonatal, Feeling Jittery, Haematochezia, Hypothermia Neonatal, Irritability, Lethargy, Myoclonus, Necrotising Enterocolitis Neonatal, Neonatal Disorder, Pneumatosis Intestinalis, Somnolence | EXP | |||||||
| F | 5879945 | 4766542 | 09/09/2005 | Paxil | Apgar Score Low, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypoglycaemia Neonatal, Hypotonia Neonatal, Irritability, Lethargy, Leukopenia Neonatal, Necrotising Enterocolitis Neonatal, Pneumatosis Intestinalis, Thrombocytopenia Neonatal, Vomiting Neonatal | EXP | ||||||
| M | 5879946 | 4766543 | 09/09/2005 | Paxil | Chills, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Hyperreflexia, Hypertonia Neonatal, Neonatal Disorder, Transient Tachypnoea of the Newborn | EXP | ||||||
| 5879949 | 4766544 | 09/09/2005 | Paxil | Agitation Neonatal, Depressed Level of Consciousness, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypoglycaemia Neonatal, Hyporeflexia, Hypotonia Neonatal, Lethargy | EXP | |||||||
| F | 5882177 | 4773828 | 09/20/2005 | Seroxat | PH | Drug Exposure During Pregnancy, Normal Newborn, Premature Baby | EXP | |||||
| M | 5886102 | 4779948 | 09/27/2005 | Paroxetine | MD | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Hypospadias | EXP | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| M | 5886102 | 4804398 | 10/20/2005 | Paroxetine | MD | Depression | Drug Exposure During Pregnancy, Hypospadias | EXP | ||||
| M | 5886605 | 4778441 | 09/07/2005 | 09/23/2005 | Paxil | MD | Depression | Congenital Anomaly, Drug Exposure During Pregnancy, Hypospadias | DIR | |||
| F | 5889834 | 4785552 | 10/03/2005 | Paxil | CN | Drug Use for Unknown Indication | Abortion Spontaneous, Pregnancy of Partner | EXP | ||||
| F | 5889837 | 4785555 | 10/03/2005 | Paxil | CN | Drug Use for Unknown Indication | Cardiac Disorder, Drug Exposure During Pregnancy, Heart Disease Congenital | EXP | ||||
| 5890618 | 4787003 | 10/04/2005 | Seroxat | MD | Obsessive-Compulsive Disorder | Atrial Septal Defect, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Sedation | EXP | |||||
| F | 5891476 | 4784378 | 07/13/2001 | 09/29/2005 | 07/13/2001 | Paxil | OT | Depression | Drug Exposure During Pregnancy, Placental Disorder, Small for Dates Baby, Stillbirth | DIR | ||
| F | 5892354 | 4789790 | 10/06/2005 | Paxil | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Intra-Uterine Death, Placental Disorder, Umbilical Cord Abnormality, Umbilical Cord Vascular Disorder | EXP | ||||
| M | 5892400 | 4786675 | 08/19/1998 | 10/03/2005 | Paxil | CN | Depression, Drug Withdrawal Syndrome | Craniosynostosis, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyspnoea, Hyperacusis, Infantile Apnoeic Attack, Irritability, Neonatal Disorder, Pierre Robin Syndrome | DIR | |||
| M | 5898843 | 4804436 | 01/01/2004 | 10/20/2005 | Seroxat | CN | Drug Use for Unknown Indication | Convulsion, Convulsion Neonatal, Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Eating Disorder, Ill-Defined Disorder, Learning Disability, Muscle Twitching, Neonatal Disorder, Retrognathia, Small for Dates Baby | EXP | |||
| F | 5898845 | 4797300 | 10/13/2005 | Seroxat | CN | Depression | Anxiety, Chills, Cleft Palate, Congenital Anomaly, Drug Exposure During Pregnancy, Dyspnoea, Fatigue, Fear, Feeling Cold, Heart Disease Congenital, Hyperhidrosis, Insomnia, Pain, Palpitations, Self-Injurious Ideation, Sensory Disturbance, Suicidal Ideation | EXP | ||||
| F | 5898846 | 4797302 | 10/13/2005 | Seroxat | CN | Cardiac Disorder, Cleft Palate, Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Hereditary Disorder, Palatal Disorder, Small for Dates Baby, Speech Disorder | EXP | |||||
| F | 5901343 | 4795627 | 03/02/2001 | 10/07/2005 | Paxil | OT | Anxiety, Depression, Post-Traumatic Stress Disorder | Abortion Spontaneous, Blood Human Chorionic Gonadotropin Increased, Developmental Delay, Drug Exposure During Pregnancy, Pregnancy, Thanatophoric Dwarfism | DIR | |||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| F | 5902151 | 4800131 | 10/17/2005 | Paroxetine | CN | Depression | Convulsion, Drug Exposure During Pregnancy, Dyskinesia, Feeling Jittery, Hyperreflexia, Hypertonia Neonatal, Hypotonia, Infection, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Neonatal Tachycardia, Opisthotonus, Polycythaemia, Posturing, Psychomotor Hyperactivity, Pyrexia, Tremor | EXP | ||||
| M | 5903393 | 4801700 | 10/12/2005 | 10/18/2005 | Paxil | MD | Drug Exposure During Pregnancy, Neonatal Asphyxia, Somnolence Neonatal | EXP | ||||
| M | 5903393 | 4820627 | 10/12/2005 | 11/04/2005 | Paxil | MD | Drug Exposure During Pregnancy, Neonatal Asphyxia, Somnolence Neonatal | EXP | ||||
| M | 5903393 | 4842603 | 10/12/2005 | 12/01/2005 | Paxil | MD | Drug Exposure During Pregnancy, Neonatal Asphyxia, Somnolence Neonatal | EXP | ||||
| M | 5903945 | 4810249 | 10/26/2005 | Paroxetine | CN | Alpha Haemolytic Streptococcal Infection, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Foetal Distress Syndrome, Hypertonia, Hypoglycaemia, Inappropriate Antidiuretic Hormone Secretion, Opisthotonus, Salivary Hypersecretion | EXP | |||||
| 5906126 | 4805992 | 10/21/2005 | Paxil | OT | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Foetal Malformation | EXP | |||||
| F | 5907119 | 4807120 | 10/24/2005 | Paxil | MD | Depression | Antepartum Haemorrhage | EXP | ||||
| M | 5907462 | 4802122 | 02/08/2005 | 10/12/2005 | Paroxetine | Social Phobia | Congenital Aortic Stenosis, Drug Exposure During Pregnancy | EXP | ||||
| F | 5907905 | 4808560 | 10/25/2005 | Paxil | CN | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy, Pregnancy | EXP | ||||
| F | 5907905 | 4819181 | 11/03/2005 | Paxil | CN | Drug Use for Unknown Indication | Abortion Spontaneous, Libido Decreased | EXP | ||||
| F | 5915416 | 4816997 | 01/01/2000 | 11/01/2005 | Paxil | CN | Drug Use for Unknown Indication | Abortion Spontaneous, Drug Exposure During Pregnancy | EXP | |||
| M | 5916840 | 4819182 | 03/19/2005 | 11/03/2005 | Paxil | CN | Depression | Cleft Palate, Crying, Drug Exposure During Pregnancy, Insomnia | EXP | |||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| F | 5916862 | 4819210 | 06/07/2005 | 11/03/2005 | Deroxat | CN | Drug Exposure During Pregnancy, Hypercalcaemia, Premature Baby | EXP | ||||
| 5921221 | 4825796 | 09/25/2004 | 11/11/2005 | Deroxat | CN | Obsessive-Compulsive Disorder | Drug Exposure During Pregnancy, Hypoxia, Intra-Uterine Death | EXP | ||||
| F | 5926139 | 4832892 | 11/21/2005 | Paroxetine | CN | Convulsion, Drug Exposure During Pregnancy, Dyskinesia, Dyskinesia Neonatal, Hyperexplexia, Hyperreflexia, Hypertonia, Hypertonia Neonatal, Neonatal Disorder, Opisthotonus, Posture Abnormal, Pyrexia, Respiratory Distress, Serotonin Syndrome, Tachypnoea | EXP | |||||
| F | 5932313 | 4841333 | 11/20/2005 | 11/30/2005 | Paxil | MD | Panic Disorder | Caesarean Section, Drug Exposure During Pregnancy, Premature Labour, Twin Pregnancy | EXP | |||
| M | 5932314 | 4841334 | 11/20/2005 | 11/30/2005 | Paxil | MD | Caesarean Section, Drug Exposure During Pregnancy, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby | EXP | ||||
| M | 5932314 | 4845323 | 11/20/2005 | 12/05/2005 | Paxil | MD | Drug Exposure During Pregnancy, Dyspepsia, Gastrointestinal Hypomotility, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby, Tachypnoea | EXP | ||||
| M | 5932314 | 4865205 | 11/20/2005 | 12/23/2005 | Paxil | MD | Drug Exposure During Pregnancy, Dyspepsia, Gastrointestinal Hypomotility, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby, Respiratory Disorder, Tachypnoea | EXP | ||||
| M | 5932315 | 4841335 | 11/20/2005 | 11/30/2005 | Paxil | MD | Caesarean Section, Drug Exposure During Pregnancy, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby | EXP | ||||
| M | 5932315 | 4845324 | 11/20/2005 | 12/05/2005 | Paxil | MD | Drug Exposure During Pregnancy, Dyspepsia, Gastrointestinal Hypomotility, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby, Tachypnoea | EXP | ||||
| M | 5932315 | 4865206 | 11/20/2005 | 12/23/2005 | Paxil | MD | Drug Exposure During Pregnancy, Dyspepsia, Gastrointestinal Hypomotility, Hypoglycaemia Neonatal, Infantile Apnoeic Attack, Premature Baby, Respiratory Disorder, Tachypnoea | EXP | ||||
| 5933590 | 4842608 | 11/08/2005 | 12/01/2005 | Paxil | MD | Drug Exposure During Pregnancy, Irritability, Respiratory Disorder Neonatal | EXP | |||||
| 5933590 | 4852204 | 11/08/2005 | 12/13/2005 | Paxil | MD | Drug Exposure During Pregnancy, Irritability, Respiratory Disorder Neonatal | EXP | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Reactions | Rpt Code | |
| 5933590 | 5123844 | 11/08/2005 | 10/10/2006 | Paxil | MD | Drug Exposure During Pregnancy, Irritability, Respiratory Disorder Neonatal | EXP | |||||
| F | 5934236 | 4835936 | 11/18/2005 | Paroxetine | Convulsion Neonatal, Drug Exposure During Pregnancy, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Polycythaemia, Pyrexia, Serotonin Syndrome | EXP | ||||||
| M | 5935180 | 4848424 | 01/01/2005 | 12/08/2005 | Paxil CR | OT | Depression | Adrenal Insufficiency, Arnold-Chiari Malformation, Drug Exposure During Pregnancy, Premature Baby | EXP | |||
| M | 5935180 | 4976755 | 01/01/2005 | 04/19/2006 | Paxil CR | OT | Depression | Adrenal Insufficiency, Adrenogenital Syndrome, Arnold-Chiari Malformation, Developmental Delay, Drug Exposure During Pregnancy, Premature Baby | EXP | |||
| M | 5935180 | 5046427 | 01/01/2005 | 07/10/2006 | Paxil CR | OT | Depression | Adrenal Insufficiency, Adrenogenital Syndrome, Arnold-Chiari Malformation, Developmental Delay, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus, Premature Baby | EXP | |||
| M | 5935180 | 5094238 | 01/01/2005 | 08/31/2006 | Paxil CR | OT | Depression | Adrenal Insufficiency, Adrenogenital Syndrome, Arnold-Chiari Malformation, Developmental Delay, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus, Premature Baby | EXP | |||
| M | 5935180 | 5416700 | 01/01/2005 | 08/16/2007 | Paxil CR | OT | Depression | Adrenal Insufficiency, Adrenogenital Syndrome, Arnold-Chiari Malformation, Developmental Delay, Drug Exposure During Pregnancy, Premature Baby, Speech Disorder Developmental | EXP | |||
| M | 5938624 | 4849128 | 01/01/2005 | 12/09/2005 | Paroxetine | CN | Depression | Drug Exposure During Pregnancy, Spina Bifida | EXP | |||
| F | 5940816 | 4861090 | 12/20/2005 | Paroxetine | CN | Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Grand Mal Convulsion, Hyperreflexia, Hypertonia, Neonatal Respiratory Distress Syndrome, Opisthotonus, Polycythaemia, Psychomotor Hyperactivity, Pyrexia, Serotonin Syndrome, Tremor | EXP | |||||
| F | 5940816 | 4879784 | 01/13/2006 | Paroxetine | CN | Convulsion, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Hyperreflexia, Hypertonia Neonatal, Neonatal Respiratory Distress Syndrome, Opisthotonus, Polycythaemia, Psychomotor Hyperactivity, Pyrexia, Serotonin Syndrome, Tonic Clonic Movements, Tremor | EXP | |||||
| M | 5941076 | 4853296 | 01/01/2004 | 12/14/2005 | Paxil | CN | Depression | Aortic Valve Disease, Atrial Septal Defect, Bicuspid Aortic Valve, Coarctation of the Aorta, Drug Exposure During Pregnancy, Mitral Valve Disease, Mitral Valve Incompetence, Ventricular Septal Defect | EXP | |||