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.
In December 2005, the FDA announced that it was again requiring GlaxoSmithKline to add additional warnings about Paxil birth defects to the drug’s prescribing information. The action was prompted by the publication of two more studies showing that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population.
The FDA advised health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. The agency also said health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In addition, the FDA also decided to place Paxil in a new pregnancy category. The FDA had previously classified the Paxil birth defect risk as Category C (Risk of Fetal Harm Cannot be Ruled Out). The new Paxil labeling now classified the birth defect risk as Category D (Positive Evidence of Fetal Risk).
In general, Paxil should not be taken during pregnancy. Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy. However, women taking Paxil should not stop taking it without first talking with their physician as Paxil withdrawal symptoms can be severe.
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