Paxil Birth Defects
In December 2005, the Food and Drug Administration warned that women taking Paxil during the first trimester of pregnancy were twice as likely to give birth to a child with birth defects. The most frequent of these Paxil birth defects were atrial septal defects (ASD) or ventricular septal defects (VSD), two types of congenital heart defects in which the wall separating the left and right side of the heart is not fully developed.
The Food and Drug Administration issued a second 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 July 2006 study 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 a serious and potentially fatal circulatory condition called persistent pulmonary hypertension (PPHN).
In addition to these conditions, Paxil has been associated with a number of other serious congenital birth defects, including cardiomyopathy, craniosynostosis, hypoplastic left heart syndrome (HLHS), hypoplastic right heart syndrome (HRHS), omphalocele, patent ductus arteriosus, bicuspid aortic valve, tricuspid stenosis, club foot, limb reductions, spina bifida, anencephaly, and cleft mitral valve
So far there has been no Paxil recall issued due to the side effects associated with the drug. However, as a result of the two studies, GlaxoSmithKline updated the Paxil warning label in September 2005 at the request of the FDA. The new label changed the pregnancy category for Paxil from C to D. 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 other congenital birth defects after taking Paxil while pregnant, contact the lawyers at Hissey Kientz, LLP for a free consultation. You can reach us by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form on the right of this page.