Safety information for Paxil , one of the most popular antidepressants on the market, has been updated twice to warn that the drug has been associated with birth defects. The Food & Drug Administration (FDA) requested the labeling updates on two occasions in 2005, after studies linked Paxil to heart defects in infants whose mothers had taken the drug in the first trimester of pregnancy.
Paxil, first marketed by GlaxoSmithKline in 1992, was the first antidepressant formally approved in the US for the treatment of social anxiety disorder. It is also approved to treat symptoms of depression, obsessive-compulsive disorder, post-traumatic stress disorder, panic disorder, generalized anxiety disorder, and premenstrual dysphoric disorder. By 2006, Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions.
In September 2005, GlaxoSmithKline published a study of major birth defects in infants born to women who took antidepressants - including Paxil - early in their pregnancy. In the study of more than 3,500 pregnant women, Paxil was linked to twice as many major birth defects as other antidepressants, according to the FDA. Most of the birth defects seen in the study were heart related, and the most common heart malformations were ventricular septal defects, which are holes between the heart's two main pumping chambers. At that time, the FDA asked GlaxoSmithKline to update the Paxil label's precautions section to include data from this study.