Paxil And Birth Defects
In July 2006, the FDA sent a warning letter to doctors alerting them to the risk of Paxil side effects in children born to women who used Paxil during pregnancy.
The warning was issued after a study published in the New England Journal of Medicine found that women who took Paxil after the 20th week of pregnancy were six times more likely to give birth to children with persistent pulmonary hypertension (PPHN), as compared with women who did not take antidepressants.
A Canadian study of pregnancies between January 1997 and July 2003 found that babies born to women who were taking a 25-mg dose of Paxil during the first trimester of pregnancy had a 200% increase in major birth defects and a 300% increase in heart defects.
Women who took Paxil after the 20th week of pregnancy were six times more likely to give birth to babies with PPHN.
Paxil and PPHN
PPHN is a circulatory condition associated with taking Paxil during pregnancy. This Paxil birth defect impairs a newborn’s ability to deliver a fresh supply of oxygen to the blood.
About 10% of babies born with this Paxil side effect will die from the condition. Among children who survive, about 15–20% will have major neurological problems.
Congenital heart defects from taking Paxil during pregnancy
In December 2005, the FDA warned that women taking Paxil during the first trimester of pregnancy increase the risk that their baby will be born with birth defects. The most frequent of these Paxil birth defects were atrial or ventricular septal defects, in which the wall separating the left and right side of the heart is not fully developed.
No Paxil recall—yet
There has been no Paxil recall because of the side effects associated with the drug. However, as a result of these studies, GlaxoSmithKline updated the Paxil warning label in September 2005 at the request of the FDA.
The new warning label changed the pregnancy category for Paxil from C to D, a stronger warning. Category D drugs have been shown to cause risks to the fetus in controlled or observational studies.
If your child has suffered a congenital heart defect, PPHN or another congenital birth defect because of Paxil during pregnancy, you may wish to consider filing a Paxil lawsuit. An experienced Paxil lawyer can help you understand the legal issues surrounding these and other Paxil side effects, and assist you in proceeding with your claim.
