Imipramine - Congenital, Prenatal & Neonatal Adverse Rections

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

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

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


Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
F 4148220 4365350 04/24/2004 05/20/2004 Tofranil Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus, Trisomy 21
F 5759477 4610225 03/16/2005 Tofranil MD Depression Abortion Induced, Drug Exposure During Pregnancy
M 5793080 4658592 05/11/2005 Tofranil CN Apnoea, Convulsion, Drug Exposure During Pregnancy, Lung Disorder, Premature Baby
M 5810381 4675787 05/04/2005 05/25/2005 Tofranil Convulsion Neonatal, Drug Exposure During Pregnancy, Neonatal Apnoeic Attack, Premature Baby, Pulmonary Malformation, Small for Dates Baby
5840597 4718544 07/20/2005 Tofranil PH Agitation Neonatal, Drug Exposure During Pregnancy
F 5937222 4847505 12/07/2005 Imipramine Panic Disorder Caesarean Section, Drug Exposure During Pregnancy, Premature Rupture of Membranes, Threatened Labour
F 5937222 4876367 01/10/2006 Tofranil Panic Disorder Caesarean Section, Drug Exposure During Pregnancy, Premature Rupture of Membranes, Threatened Labour
6295926 5306849 04/25/2007 Imipramine Agitation Neonatal, Drug Exposure During Pregnancy, Poor Sucking Reflex, Somnolence Neonatal
F 6560021 5636311 02/25/2008 Imipramine PH Meconium In Amniotic Fluid, Premature Labour
0 Days 5874453 4763662 08/25/2005 09/08/2005 Tofranil MD Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Wheezing
0 Days M 5874453 4785977 08/25/2005 10/03/2005 Tofranil MD Congenital Limb Hyperextension, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Gaze Palsy, Hypertonia Neonatal, Irritability, Neonatal Disorder, Restlessness, Tremor, Wheezing
0 Days M 5874453 4791296 08/25/2005 10/07/2005 Tofranil MD Congenital Limb Hyperextension, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Gaze Palsy, Hypertonia Neonatal, Irritability, Restlessness, Tremor, Wheezing
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
1 Day M 5937224 4847507 12/07/2005 Imipramine Apnoeic Attack, Circulatory Failure Neonatal, Pallor
1 Day M 5937224 4876365 01/01/2001 01/10/2006 Tofranil Apnoeic Attack, Cerebral Palsy, Circulatory Failure Neonatal, Drug Exposure During Pregnancy, Pallor
2 Days F 6517012 5577612 10/28/2007 12/31/2007 Tofranil MD Aspartate Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Decreased Activity, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Distress Syndrome, Hypertonia Neonatal, Irritability, Leukocytosis, Meconium Stain, Neonatal Disorder, Poor Sucking Reflex, Pyrexia, Thrombocythaemia, Tremor Neonatal
44 Days M 5793080 4672442 05/24/2005 Tofranil CN Apnoea, Convulsion, Drug Exposure During Pregnancy, Lung Disorder, Premature Baby
44 Days M 5793080 4682700 06/06/2005 Tofranil CN Agitation, Apnoea, Convulsion, Convulsion Neonatal, Crying, Drug Exposure During Pregnancy, Lung Disorder, Neonatal Apnoeic Attack, Premature Baby
24 Years F 4163233 4385837 06/22/2004 Tofranil Asphyxia, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Drug Interaction, Drug Toxicity, Petechiae, Respiratory Disorder, Urine Abnormality
28 Years F 6517011 5577611 10/28/2007 12/31/2007 Tofranil MD Depression Drug Exposure During Pregnancy, Ventouse Extraction
34 Years F 5796171 4662201 05/16/2005 Tofranil CN Abdominal Pain, Drug Exposure During Pregnancy, Premature Labour
34 Years F 5796171 4669529 05/08/2005 05/23/2005 Tofranil CN Abdominal Pain, Bronchitis, Dizziness, Drug Exposure During Pregnancy, Headache, Insomnia, Premature Labour
34 Years F 5796171 4682617 05/08/2005 06/06/2005 Tofranil CN Abdominal Pain, , Bronchitis, Convulsion Neonatal, Dizziness, Drug Exposure During Pregnancy, Headache, Insomnia, Neonatal Apnoeic Attack, Premature Labour
34 Years F 5810377 4675784 05/04/2005 05/25/2005 Tofranil Abdominal Pain, Bronchitis, Dizziness, Drug Exposure During Pregnancy, Headache, Insomnia, Premature Labour
3 Males 9 Females 15 Cases (Gender was not reported for 3 Cases) 23 Individual Safety Reports

This is a list of all Primary Suspect Drugs reported in the Detail Table

Imipramine (imipramine), Tofranil (imipramine)

These are the Adverse Reactions culled from the Individual Safety Reports in the Detail Table

Abdominal Pain, Abortion Induced, Agitation, Agitation Neonatal, Apnoea, Apnoeic Attack, Aspartate Aminotransferase Increased, Asphyxia, Blood Lactate Dehydrogenase Increased, Bronchitis, Caesarean Section, Cerebral Palsy, Circulatory Failure Neonatal, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Limb Hyperextension, Convulsion, Convulsion Neonatal, Crying, Decreased Activity, Dizziness, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Interaction, Drug Toxicity, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Foetal Distress Syndrome, Gaze Palsy, Headache, Hypertonia Neonatal, Insomnia, Irritability, Leukocytosis, Lung Disorder, Maternal Drugs Affecting Foetus, Meconium In Amniotic Fluid, Meconium Stain, Neonatal Apnoeic Attack, Neonatal Disorder, Pallor, Petechiae, Poor Sucking Reflex, Premature Baby, Premature Labour, Premature Rupture of Membranes, Pulmonary Malformation, Pyrexia, Respiratory Disorder, Restlessness, Small for Dates Baby, Somnolence Neonatal, Threatened Labour, Thrombocythaemia, Tremor, Tremor Neonatal, Trisomy 21, Urine Abnormality, Ventouse Extraction, Wheezing


Imipramine Adverse Reaction Definitions
  
Cerebral Palsy Cerebral palsy (CP) is the term used for a group of nonprogressive disorders of movement and posture caused by abnormal development of, or damage to, motor control centers of the brain. CP is caused by events before, during, or after birth.

Voluntary movement (walking, grasping, chewing, etc.) is primarily accomplished using muscles that are attached to bones, known as the skeletal muscles. Control of the skeletal muscles originates in the cerebral cortex, the largest portion of the brain. Palsy means paralysis, but may also be used to describe uncontrolled muscle movement. Therefore, cerebral palsy encompasses any disorder of abnormal movement and paralysis caused by abnormal function of the cerebral cortex. [Images]
  
Congenital A physical abnormality that is present at birth.
  
Drug Withdrawal Syndrome Neonatal Refers to the characteristic signs and symptoms that appear when a drug that causes physical dependence is regularly used for a long time and then suddenly discontinued or decreased in dosage. Also known as abstinence syndrome. A group of unpleasant symptoms produced by the abrupt termination of drug taking. These symptoms, commonly called withdrawal symptoms, include anxiety, muscle weakness, nausea, vomiting, tremor, and a rapid heart beat.
  
Foetal Distress Syndrome An abnormal condition of a fetus during gestation or at the time of delivery, marked by altered heart rate or rhythm and leading to compromised blood flow or changes in blood chemistry.
  
Gaze Palsy Refers to the inability of both eyes to move in the same direction at the same time. [Images]
  
Hypertonia Extreme tension of the muscles or arteries.
  
Neonatal Apnoeic Attack Temporary absence or cessation of breathing in a newborn.
  
Trisomy A condition in which an extra copy of a chromosome is present in the cell nuclei, causing developmental abnormalities.
  
Trisomy 21 Down syndrome is the most common cause of mental retardation and malformation in a newborn. It occurs because of the presence of an extra chromosome. The extra chromosome in Down syndrome is labeled number 21. For this reason, the existence of three such chromosomes is sometimes referred to as Trisomy 21. [Images]
  
Ventouse Extraction Vacuum extraction (delivery) of the fetus.
  

MedWatch Reporting by Consumers

MedWatch is the Food and Drug Administration's program for reporting any undesirable experience associated with the use of a medical product. If you think you or someone in your family has experienced an adverse reaction from taking Imipramine and it has not been reported to the FDA, see this page for instructions on reporting the adverse event through your doctor or directly to the FDA using an online form.

A May 2006 USA Today article states that "drug companies are required to file any reports they have to the FDA, but consumers and doctors report such events on a voluntary basis. Studies suggest the FDA's Adverse Events Reporting System database captures only 1% to 10% of drug-induced side effects and deaths, "maybe even less than 1%," says clinical pharmacologist Alastair J.J. Wood, an associate dean at Vanderbilt Medical School in Nashville. So the real number of cases is almost certainly much higher".