• Robert D. Rowland

Paxil Safety Risk

SAFETY ALERT: FDA Paxil Birth Defect Warning

In 2005, The U.S. Food and Drug Administration issued a safety alert regarding Paxil (paroxetine), an antidepressant medication that has been prescribed since 1992 for depression, anxiety and obsessive compulsive disorders.

The FDA warned patients and doctors of the possible link between Paxil (paroxetine) and heart valve defects in infants. When Paxil is taken during pregnancy, it may cause atrial septal and ventricular septal defects (ASD or VSD) in babies. These defects are holes in between the chambers of the heart that are supposed to be separated. The hole allows some of the blood to flow in the wrong direction. These heart defects often require multiple surgeries at an early age.

Before prescribing Paxil (paroxetine), health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.

Paxil Birth Defects

When taken during pregnancy, Paxil (paroxetine) has been linked to a variety of extremely severe birth defects including:

1. Cardiac birth defects: septal heart defects, pulmonary valve stenosis and left ventricular outflow defects (aortic valve stenosis, subvalveular aortic stenosis and supravalvular aortic stenosis)

2. Abdominal birth defects: including omphalocele (organs on the outside of the body), gastroschisis (protruding intestines) and pyloric stenosis (blockage preventing stomach from draining). The New England Journal of Medicine in June 2007 found that use of SSRI drugs in the first trimester doubled the risk of club foot, anal atresia, diaphragmatic hernia and limb reduction defects. Another study, the National Birth Defects Prevention Study showed the risk of anencephaly, crainosynostosis and omphlocele were doubled with use

3. Cranial birth defects: including crainosynostosis (joints in skull close prematurely) and anencephaly (absence of a major portion of the brain, skull and scalp resulting in still birth)

4. Respiratory defects: particularly Persistent Pulmonary Hypertension of the Newborn (PPHN) which means the ductus does not close and the baby’s blood flow bypasses the lungs like it did before birth (caused by third trimester exposure). The FDA in July 2006 issued a warning that said women who took SSRI’s are six times more likely to give birth to a child with PPHN.

5. Other defects: including club foot, cystic kidney, cleft lip and palate, spina bifida, hypospadius (abnormal opening in the penis), atresia (absence or abnormal closure) of the anus, esophagus or intestines

If you or a loved one have taken Paxil (paroxetine) while pregnant and given birth to a child with a congenital birth defect, contact us.

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