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 | ||||
| 4042874 | 4289648 | 01/01/2003 | 01/26/2004 | Strattera | PH | Limb Malformation | ||||||||
| F | 4042874 | 4341872 | 04/15/2004 | Strattera | PH | Drug Exposure During Pregnancy | ||||||||
| 4148345 | 4364662 | 05/21/2004 | Strattera | MD | Anencephaly, Intra-Uterine Death, Transmission of Drug Via Semen | |||||||||
| 4148345 | 4464694 | 04/01/2004 | 09/29/2004 | Strattera | MD | Abortion Induced, Anencephaly, Drug Exposure During Pregnancy, Transmission of Drug Via Semen | ||||||||
| F | 4205958 | 4441500 | 07/28/2004 | Strattera | Attention Deficit/Hyperactivity Disorder | Abortion Spontaneous | ||||||||
| 6041125 | 4985900 | 04/19/2006 | Strattera | MD | Drug Exposure During Pregnancy, Stillbirth | |||||||||
| 6041125 | 5022685 | 06/01/2005 | 06/05/2006 | 02/18/2006 | Strattera | MD | Drug Exposure During Pregnancy, Intra-Uterine Death, Labour Complication, Stillbirth | |||||||
| 6041125 | 5053558 | 06/01/2005 | 07/12/2006 | 02/18/2006 | Strattera | MD | Anoxia, Drug Exposure During Pregnancy, Labour Complication, Stillbirth | |||||||
| 6045434 | 4990718 | 02/01/2006 | 04/28/2006 | 02/01/2006 | Strattera | Drug Exposure During Pregnancy, Stillbirth | ||||||||
| 6045434 | 5053551 | 02/01/2006 | 07/12/2006 | 02/01/2006 | Strattera | Drug Exposure During Pregnancy, Stillbirth | ||||||||
| 6142862 | 5117527 | 09/26/2006 | Strattera | OT | Cleft Palate, Congenital Anomaly, Drug Exposure During Pregnancy | |||||||||
| 6142862 | 5141774 | 10/27/2006 | Strattera | Attention Deficit/Hyperactivity Disorder | Cleft Lip, Drug Exposure During Pregnancy | |||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6144742 | 5117518 | 09/26/2006 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cleft Palate, Drug Exposure During Pregnancy | ||||||||
| 6144742 | 5141734 | 10/27/2006 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cleft Lip, Cleft Palate, Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||
| 6294395 | 5304803 | 04/23/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cleft Palate, Drug Exposure During Pregnancy | ||||||||
| 6294395 | 5306294 | 04/24/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cleft Palate, Drug Exposure During Pregnancy, Premature Baby | ||||||||
| 6294395 | 5363999 | 06/20/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cleft Palate, Drug Exposure During Pregnancy, Premature Baby | ||||||||
| 6294395 | 5367853 | 06/22/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cleft Palate, Drug Exposure During Pregnancy | ||||||||
| 6294395 | 5368829 | 06/25/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cleft Palate, Drug Exposure During Pregnancy | ||||||||
| 6294399 | 5304807 | 04/23/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cleft Lip, Drug Exposure During Pregnancy | ||||||||
| 6294399 | 5306289 | 04/24/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cleft Lip, Drug Exposure During Pregnancy, Premature Baby | ||||||||
| 6294399 | 5364013 | 06/20/2007 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cleft Lip, Drug Exposure During Pregnancy | ||||||||
| 6465649 | 5514742 | 11/13/2007 | Strattera | CN | Obsessive-Compulsive Disorder | Congenital Cardiovascular Anomaly, Drug Exposure During Pregnancy, Pneumothorax | ||||||||
| M | 6569914 | 5649883 | 09/01/2007 | 03/04/2008 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Adenotonsillectomy, Congenital Central Nervous System Anomaly, Convulsion, Drug Interaction, Electroencephalogram Abnormal, Hallucination (Auditory), Hallucination (Visual) | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6590829 | 5676222 | 03/21/2008 | Strattera | MD | Drug Exposure During Pregnancy, Pre-Eclampsia | ||||||||
| F | 6590836 | 5676230 | 03/21/2008 | Strattera | MD | Congenital Foot Malformation, Drug Exposure During Pregnancy, Premature Baby | ||||||||
| 1 | Day | M | 4094998 | 4300168 | 12/18/2003 | 02/18/2004 | Strattera | Forceps Delivery, Intraventricular Haemorrhage, Maternal Drugs Affecting Foetus, Neonatal Disorder, Pain | ||||||
| 1 | Day | M | 4094998 | 4356767 | 12/18/2003 | 05/07/2004 | Strattera | MD | Intraventricular Haemorrhage Neonatal, Maternal Drugs Affecting Foetus, Pain | |||||
| 1 | Day | M | 5911905 | 4806496 | 04/08/2005 | 10/19/2005 | Strattera | CN | Drug Exposure During Pregnancy, Immature Respiratory System, Premature Baby | |||||
| 10 | Years | F | 6042847 | 4989645 | 01/11/2006 | 04/26/2006 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Chest Pain, Coarctation of the Aorta, Headache, Hypertension | ||||
| 10 | Years | F | 6042847 | 5063160 | 01/11/2006 | 07/24/2006 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Cardiac Valve Disease, Chest Pain, Coarctation of the Aorta, Headache, Hypertension | ||||
| 11 | Years | M | 5682592 | 4498249 | 04/01/2004 | 09/27/2004 | Strattera | Attention Deficit/Hyperactivity Disorder | Abnormal Behaviour, Birth Mark, Crying, Disturbance In Attention, Irritability, Mood Altered, Vein Discolouration | |||||
| 12 | Years | 5650226 | 4476619 | 10/13/2004 | Strattera | OT | Cardiomyopathy, Congenital Anomaly | |||||||
| 13 | Years | M | 4136881 | 4351417 | 03/29/2004 | 04/28/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Cardiomegaly, Cardiomyopathy, Dyspnoea | ||||
| 13 | Years | M | 4136881 | 4373146 | 03/29/2004 | 06/03/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Anorexia, Carnitine Increased, Chromosome Abnormality, Congestive Cardiomyopathy, Ejection Fraction Decreased, Hepatitis C Positive, HIV Test Positive, Urine Analysis Abnormal | ||||
| 13 | Years | 5650226 | 4522458 | 03/29/2004 | 12/07/2004 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Body Temperature Decreased, Cardiac Failure Congestive, Cardiac Murmur, Cardiomegaly, Cardiomyopathy, Dyspnoea, Mitral Valve Incompetence, Pleural Effusion, Sinus Tachycardia, Tricuspid Valve Incompetence, Viral Infection, Vomiting | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 14 | Years | F | 5680016 | 4502211 | 10/24/2004 | 11/09/2004 | Atomoxetine | PH | Attention Deficit/Hyperactivity Disorder | Abortion Induced, Convulsion, Drug Exposure During Pregnancy | ||||
| 14 | Years | F | 5680016 | 4522533 | 10/22/2004 | 12/07/2004 | Atomoxetine | PH | Attention Deficit/Hyperactivity Disorder | Abortion Induced, Drug Exposure During Pregnancy, Epilepsy | ||||
| 14 | Years | F | 5680016 | 4540370 | 10/22/2004 | 12/22/2004 | Atomoxetine | PH | Attention Deficit/Hyperactivity Disorder | Abortion Induced, Drug Exposure During Pregnancy, Epilepsy | ||||
| 17 | Years | F | 4205986 | 4440746 | 03/27/2004 | 07/28/2004 | Strattera | OT | Attention Deficit/Hyperactivity Disorder | Prolonged Labour | ||||
| 22 | Years | F | 5752581 | 4580254 | 12/16/2003 | 01/27/2005 | Strattera | OT | Attention Deficit/Hyperactivity Disorder | Abortion Spontaneous | ||||
| 25 | Years | F | 6384021 | 5415914 | 01/01/2007 | 08/15/2007 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 25 | Years | F | 6543533 | 5613887 | 02/05/2008 | Strattera | CN | Disturbance In Attention | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| 31 | Years | F | 5915256 | 4806567 | 12/01/2004 | 10/19/2005 | Strattera | Attention Deficit/Hyperactivity Disorder | Drug Exposure During Pregnancy, High Risk Pregnancy, Premature Labour | |||||
| 38 | Years | F | 5752476 | 4580213 | 01/01/2004 | 01/27/2005 | Strattera | CN | Attention Deficit/Hyperactivity Disorder | Abortion Spontaneous | ||||
| 38 | Years | F | 5903912 | 4786632 | 09/27/2005 | Strattera | MD | Attention Deficit/Hyperactivity Disorder | Placenta Praevia | |||||
| 5 Males | 12 Females | 27 Cases (Gender was not reported for 10 Cases) | 46 Individual Safety Reports | |||||||||||
Atomoxetine (atomoxetine), Strattera (atomoxetine)
Abnormal Behaviour, Abortion Induced, Abortion Spontaneous, Adenotonsillectomy, Anencephaly, Anorexia, Anoxia, Auditory, Birth Mark, Body Temperature Decreased, Cardiac Failure Congestive, Cardiac Murmur, Cardiac Valve Disease, Cardiomegaly, Cardiomyopathy, Carnitine Increased, Chest Pain, Chromosome Abnormality, Cleft Lip, Cleft Palate, Coarctation of the Aorta, Congenital Anomaly, Congenital Cardiovascular Anomaly, Congenital Central Nervous System Anomaly, Congenital Foot Malformation, Congestive Cardiomyopathy, Convulsion, Crying, Disturbance In Attention, Drug Exposure During Pregnancy, Drug Interaction, Dyspnoea, Ejection Fraction Decreased, Electroencephalogram Abnormal, Epilepsy, Forceps Delivery, Hallucination (Auditory), Hallucination (Visual), Headache, Hepatitis C Positive, High Risk Pregnancy, HIV Test Positive, Hypertension, Immature Respiratory System, Intra-Uterine Death, Intraventricular Haemorrhage, Intraventricular Haemorrhage Neonatal, Irritability, Labour Complication, Limb Malformation, Maternal Drugs Affecting Foetus, Mitral Valve Incompetence, Mood Altered, Neonatal Disorder, Pain, Placenta Praevia, Pleural Effusion, Pneumothorax, Pre-Eclampsia, Premature Baby, Premature Labour, Prolonged Labour, Sinus Tachycardia, Stillbirth, Transmission of Drug Via Semen, Tricuspid Valve Incompetence, Urine Analysis Abnormal, Vein Discolouration, Viral Infection, Vomiting
| Definitions | |
| Abortion Spontaneous | Miscarriage means loss of an embryo or fetus before the 20th week of pregnancy. Most miscarriages occur during the first 14 weeks of pregnancy. The medical term for miscarriage is spontaneous abortion. |
| Anencephaly | Congenital absence of most of the brain and spinal cord. |
| Anoxia | Anoxia is a condition characterized by an absence of oxygen supply to an organ or a tissue. |
| Cardiomegaly | Enlargement of the heart. Also called megalocardia. |
| Cardiomyopathy | A disease or disorder of the heart muscle, especially of unknown or obscure cause. |
| Congenital | A physical abnormality that is present at birth. |
| Congenital Anomaly | Medical term for a birth defect which is a physical abnormality that is present at birth; they are also called congenital abnormalities. When multiple birth defects occur together and have a similar cause, they are called syndromes (e.g. Adrenogenital Syndrome, Dandy-Walker Syndrome, Digeorge's Syndrome, Drug Withdrawal Syndrome Neonatal). |
| Dyspnoea | Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger. |
| Placenta Praevia | Placenta previa is a condition that occurs during pregnancy when the placenta is abnormally placed, and partially or totally covers the cervix. |
| Pleural Effusion | Pleural effusion occurs when too much fluid collects in the pleural space (the space between the two layers of the pleura - two thin membranes in the chest, one lining the lungs and the other covering the inside of the chest). It is commonly known as "water on the lungs". |
| Pneumothorax | Pneumothorax is a collection of air or gas in the chest or pleural space that causes part or all of a lung to collapse. |
| Pre-Eclampsia | Abnormal state of pregnancy characterized by hypertension and fluid retention and albuminuria (the presence of albumin in the urine, sometimes indicating kidney disease); if untreated, can lead to eclampsia (coma and convulsions before, during, or shortly after childbirth, characterized by edema, hypertension, and proteinuria). |
| Top 20 Adverse Reactions | |
| Adverse Reaction | Cases |
| Drug Exposure During Pregnancy | 16 |
| Abortion Spontaneous | 5 |
| Premature Baby | 4 |
| Hallucination (Auditory/Visual) | 4 |
| Congenital Anomaly | 3 |
| Cleft Palate | 3 |
| Cleft Lip | 3 |
| Stillbirth | 2 |
| Intra-Uterine Death | 2 |
| Dyspnoea | 2 |
| Convulsion | 2 |
| Cardiomyopathy | 2 |
| Cardiomegaly | 2 |
| Abortion Induced | 2 |
| Vomiting | 1 |
| Viral Infection | 1 |
| Vein Discolouration | 1 |
| Urine Analysis Abnormal | 1 |
| Tricuspid Valve Incompetence | 1 |
| Transmission of Drug Via Semen | 1 |
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 Atomoxetine 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".