The popular SSRI antidepressant drug Paxil (Generic: paroxetine) used by millions of Americans has been linked to suicide, self-mutilation/harm and variety of severe birth defects including Persistent Pulmonary Hypertension (PPHN), heart, lung, abdominal and cranial defects.
Update: GSK Must Face Paxil Lawsuits in Illinois
GlaxoSmithKline (GSK) will need to face legal action in Illinois over claims its antidepressant Paxil caused birth defects, according to the Cook County Record. The decision came after an appeals court ruled local state courts have jurisdiction under Illinois law to preside over the lawsuits – even complaints filed by plaintiffs who have no connection to Illinois. A panel of the Illinois First District Appellate Court on Friday denied an appeal from GSK, upholding the decision of Cook County Circuit Judge Larry G. Axelrood, who had ruled the drugmaker’s “substantial in-state contacts” were enough to force the company to defend itself against all Paxil claims, including from plaintiffs who neither reside in Illinois nor participated in any clinical trial in the state.
FDA Video: SSRI Antidepressant Birth Defects
Below is an excellent video produced by the U.S. Food & Drug Administration (FDA), which warns patients and physicians of serious, life-threatening birth defects linked to SSRI antidepressants.
Read the Full Transcript: SSRI Antidepressant Birth Defects
Congenital Heart Defects
In December, 2005 the U.S. Food & Drug Administration (FDA) issued a Public Health Advisory regarding Paxil, which was based upon two separate studies done by U.S. and Swedish researchers. The FDA warned doctors and patients that exposure to Paxil during pregnancy posed a serious risk to the fetus and was linked to an increased risk of Congenital Heart Defects.
More specifically, the most common form of Paxil induced heart birth defects observed by our firm has been either atrial septal defects or ventricular septal defects.
Persistent Pulmonary Hypertension of the Newborn (PPHN)
Recently, The New England Journal of Medicine released the results of a case-controlled study wherein Paxil was linked to an increased risk of an infant being born with Persistent Pulmonary Hypertension of the Newborn (PPHN). More specifically, the study showed that PPHN was six-times more common in infants whose mothers took an SSRI antidepressant during pregnancy compared to babies whose mothers did not take an antidepressant.
Shortly after the aforementioned study was released, the FDA issued another Public Health Advisory warning that exposure to Paxil during pregnancy posed a serious risk to the fetus and was linked to an increased risk of PPHN.
Abdominal & Cranial Birth Defects
According to information released from the National Birth Defects Prevention Study of Infants, SSRI antidepressants like Paxil (accounted for 36% of all SSRI exposures) may cause two separate congenital abnormalities called Omphalocele and Craniosynostosis.
Omphalocele is a congenital (present at birth) abdominal wall defect at the base of the umbilical cord (umbilicus); the infant is born with a sac protruding through the defect which contains small intestine, liver, and large intestine.
Craniosynostosis is a congenital (present at birth) defect that causes one or more sutures on a baby’s head to close earlier than normal. Sutures are connections that separate each individual skull bones. The early closing of a suture leads to an abnormally shaped head.
Results from the study prompted GSK to send a letter to doctors and healthcare professionals advising them of a change to the Pregnancy subsection of the PRECAUTIONS section in the labels for PAXIL regarding the increased risk of Omphalocele and Craniosynostosis.
Suicide, Self-Mutilation and Harm
The FDA and The Center for Drug Evaluation and Research is currently reviewing reports of an increased risk of suicide, suicidal thinking and attempts related to the use of the drug Paxil in “children, adolescents and adults” with major depressive disorder (MDD).
These agencies are also looking at an increased incidence of self-mutilation, self-harm and related agitation surrounding the antidepressant drug Paxil belonging to the class of drugs known as SSRI’s.
Birth Defects Linked to Antidepressants
Paxil and other antidepressants have been linked to the following birth defects:
- Atrial Septal Defects (ASD)
- Ventricular Septal Defects (VSD)
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Tricuspid Valve (Ebstein’s Anomaly)
- Mitral Valve Prolapse
- Transposition of the Great Arteries (TGA)
- Transposition of the Great Vessels (TGV)
- Tetralogy of Fallot (TOF)
- Hypoplastic Left Heart Syndrome (HLHS)
- Hypoplastic Right Heart Syndrome (HRHS)
- Tricuspid Atresia
- Aortic Stenosis
- Pulmonary Atresia (PA)
- Patent Ductus Arteriosus (PDA)
- Coarctation of the Aorta
- Truncus Arteriosus
- Tricuspid Valve Stenosis
- Heart Murmur
- Pulmonary Stenosis
- Gastroschisis – abdominal wall defect
- Esophageal Stenosis
- Anal Atresia
- Spina Bifida
Antidepressant Exposure in the Womb may Influence Anxiety Later in Life: Study
A research team at UCLA studying early developmental exposure to Prozac and Lexapro has found that although the two drugs were thought to work the same, they do not cause the same long-term changes in anxiety behavior. Researchers studied the effects of the antidepressants in a mouse model that mimicked exposure during the 3rd trimester of human pregnancy. The mice that were exposed to Lexapro had permanent changes in serotonin neurotransmission and were less anxious as adults compared to mice exposed to Prozac, according to the study.
BMJ Study Links Paxil to Birth Defects
A study from the Centers for Disease Control and Prevention (CDC) and Boston University’s Slone Epidemiology Center has confirmed a link between Paxil and anencephaly, several heart defects and 2 gastrointestinal malformations in women who took Paxil during pregnancy.