Fluvoxamine - 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
4189981 4417561 01/01/2004 08/04/2004 Fluvoxamine Depression, Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Foetal Growth Retardation, Premature Baby
F 5686429 4514932 10/25/2004 12/01/2004 Fluvoxamine MD Depression Abortion Spontaneous, Alanine Aminotransferase Increased, Drug Exposure During Pregnancy
5728811 4569004 01/01/2004 02/03/2005 Fevarin OT Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Small for Dates Baby
5798773 4665455 05/19/2005 Fevarin PH Drug Exposure During Pregnancy, Dyspnoea, Muscular Weakness, Neonatal Disorder, Tachycardia
5798773 4688437 06/13/2005 Fluvoxamine PH Drug Exposure During Pregnancy, Dyspnoea, Muscular Weakness, Neonatal Disorder, Tachycardia
5963279 4884441 01/19/2006 Luvox MD Ill-Defined Disorder Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
0 Days F 5954654 4871648 08/25/2005 01/04/2006 Luvox MD Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Eye Movement Disorder, Hypotonia, Irritability, Pyrexia, Somnolence, Tremor
0 Days F 5954654 4896619 08/25/2005 01/31/2006 Luvox MD Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal, Eye Movement Disorder, Hypotonia, Irritability, Pyrexia, Somnolence, Tremor
0 Days F 5954654 4909025 08/25/2005 02/13/2006 Luvox MD Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal, Eye Movement Disorder, Fever Neonatal, Hypotonia Neonatal, Irritability, Somnolence Neonatal, Tremor Neonatal
0 Days F 5955277 4872674 02/04/2005 01/05/2006 Luvox MD Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal
0 Days F 5955277 4896618 02/04/2005 01/31/2006 Luvox MD Drug Exposure During Pregnancy Developmental Delay, Drug Withdrawal Syndrome Neonatal, Hypotonia, Tachypnoea, Tremor
0 Days F 5963279 4916488 11/25/2005 02/20/2006 Luvox MD Drug Exposure During Pregnancy Agitation Neonatal, Anxiety, Drug Withdrawal Syndrome Neonatal, Tremor Neonatal, Vomiting Neonatal
Age M/F Case # ISR Date of Event Recv'd by FDA Date of Death Drug Name Rpt'd By Indications Adverse Reactions
1 Day F 5955277 4909027 02/04/2005 02/13/2006 Luvox MD Drug Exposure During Pregnancy Developmental Delay, Drug Withdrawal Syndrome Neonatal, Hypotonia Neonatal, Respiratory Disorder Neonatal, Tremor Neonatal
1 Day F 5972500 4895209 11/09/2005 01/30/2006 Luvox MD Drug Exposure During Pregnancy Apnoea, Drug Withdrawal Syndrome Neonatal, Hypertonia, Irritability, Small for Dates Baby, Tachypnoea, Tremor
1 Day F 5972500 4916490 11/09/2005 02/20/2006 Luvox MD Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Infantile Apnoeic Attack, Irritability, Small for Dates Baby, Tachypnoea, Tremor Neonatal
3 Days F 5762095 4613548 02/01/2005 03/21/2005 Fevarin MD Drug Exposure During Pregnancy Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
5 Days M 5743253 4588320 01/01/2004 02/22/2005 01/01/2004 Fevarin MD Drug Exposure During Pregnancy Congenital Acrochordon, Congenital Hearing Disorder, Congenital Hydrocephalus, Facial Dysmorphism, Rib Deformity
16 Years F 6665874 5757567 01/01/2008 05/29/2008 Luvox MD Depression Abortion Spontaneous, Drug Exposure During Pregnancy
24 Years F 5844594 4723328 05/09/2004 07/25/2005 Floxyfral MD Anxiety Abortion Spontaneous, Drug Exposure During Pregnancy, Pneumonia
28 Years F 4201353 4433253 02/01/2003 08/24/2004 Fluvoxamine MD Obsessive-Compulsive Disorder Abortion Spontaneous, Complications of Maternal Exposure To Therapeutic Drugs, Maternal Drugs Affecting Foetus
31 Years F 5951915 4867408 09/02/2005 12/28/2005 Fluvoxamine OT Drug Dependence Anaesthetic Complication, Drug Exposure During Pregnancy
31 Years F 5951915 4884440 09/02/2005 01/19/2006 Fluvoxamine OT Drug Dependence Anaesthetic Complication, Drug Exposure During Pregnancy
36 Years F 4114717 4321844 03/18/2004 Fluvoxamine Obsessive-Compulsive Disorder Agitation, Anxiety, Asthenia, Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Convulsion, Electroconvulsive Therapy, Foetal Heart Rate Decreased, Insomnia, Irritability, Obsessive-Compulsive Disorder
37 Years F 5686429 4547966 10/25/2004 01/10/2005 Dumirox MD Depression Abortion Spontaneous, Alanine Aminotransferase Increased, 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
38 Years F 6665877 5757568 01/25/2007 05/29/2008 Luvox Social Phobia Abortion Spontaneous, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus
1 Males 11 Females 16 Cases (Gender was not reported for 4 Cases) 25 Individual Safety Reports

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

Fevarin (fluvoxamine), Floxyfral (fluvoxamine), Fluvoxamine (fluvoxamine), Luvox (fluvoxamine)

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

Abortion Spontaneous, Agitation, Agitation Neonatal, Alanine Aminotransferase Increased, Anaesthetic Complication, Anxiety, Apnoea, Asthenia, Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Congenital Acrochordon, Congenital Hearing Disorder, Congenital Hydrocephalus, Convulsion, Developmental Delay, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyspnoea, Electroconvulsive Therapy, Eye Movement Disorder, Facial Dysmorphism, Fever Neonatal, Foetal Growth Retardation, Foetal Heart Rate Decreased, Hypertonia, Hypertonia Neonatal, Hypotonia, Hypotonia Neonatal, Infantile Apnoeic Attack, Insomnia, Irritability, Maternal Drugs Affecting Foetus, Muscular Weakness, Neonatal Disorder, Obsessive-Compulsive Disorder, Pneumonia, Premature Baby, Pyrexia, Respiratory Disorder Neonatal, Rib Deformity, Small for Dates Baby, Somnolence, Somnolence Neonatal, Tachycardia, Tachypnoea, Tremor, Tremor Neonatal, Vomiting Neonatal

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.
  
Apnoea Temporary absence or cessation of breathing.
  
Asthenia Loss or lack of bodily strength; weakness; debility.
  
Congenital A physical abnormality that is present at birth.
  
Congenital Hydrocephalus Hydrocephalus is an abnormal expansion of cavities (ventricles) within the brain that is caused by the accumulation of cerebrospinal fluid, the result of an imbalance between the formation and drainage of cerebrospinal fluid (CSF). Approximately 500 milliliters (about a pint) of CSF is formed within the brain each day, by epidermal cells in structures collectively called the choroid plexus. These cells line chambers called ventricles that are located within the brain. There are four ventricles in a human brain. Once formed, CSF usually circulates among all the ventricles before it is absorbed and returned to the circulatory system. Because production is independent of absorption, reduced absorption causes CSF to accumulate within the ventricles leading to an elevation of the CSF pressure within the brain. This increased pressure pushes aside the soft tissues of the brain. This squeezes and distorts them. This process also results in damage to these tissues.
  
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.
  
Dyspnoea Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger.
  
Hypertonia Extreme tension of the muscles or arteries.
  
Hypotonia Hypotonia is a condition of abnormally low muscle tone (the amount of tension or resistance to movement in a muscle), often involving reduced muscle strength. Hypotonia is not a specific medical disorder, but a potential manifestation of many different diseases and disorders that affect motor nerve control by the brain or muscle strength.
  
Pyrexia Fever.
  
Tachycardia A rapid heart rate, especially one above 100 beats per minute in an adult.
  


Top 20 Adverse Reactions
Adverse Reaction Cases
Drug Exposure During Pregnancy 11
Drug Withdrawal Syndrome Neonatal 5
Abortion Spontaneous 5
Tremor Neonatal 4
Tremor 3
Irritability 3
Tachypnoea 2
Small for Dates Baby 2
Maternal Drugs Affecting Foetus 2
Hypotonia Neonatal 2
Hypotonia 2
Complications of Maternal Exposure To Therapeutic Drugs 2
Anxiety 2
Vomiting Neonatal 1
Tachycardia 1
Somnolence Neonatal 1
Somnolence 1
Rib Deformity 1
Respiratory Disorder Neonatal 1
Pyrexia 1


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 Fluvoxamine 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".