FDA Intensifies Warning For Pregnant Women on Paxil

By Elizabeth Rhein

Published on December 08, 2005

In light of recent studies, the Food and Drug Administration announced that the popular antidepressant will now carry a stronger warning for women who are pregnant or who plan to become pregnant while on the drug.

The new warning follows closely on the heels of the FDA's first pregnancy-related Paxil warning, which was released in September 2005.

The most recent studies point to an increased likelihood of birth defects in fetuses whose mothers are taking the drug. Specifically, those babies have been shown to have a rate of congenital heart defects that is nearly double the average rate.

The risk of defects has shown to be especially high when Paxil is taken during the first trimester of pregnancy. As a result, the FDA is cautioning doctors not to prescribe the antidepressant during this period unless there are no other feasible options, or in cases where the benefits of the drug outweigh the possible risk to the fetus.

Paxil's manufacturer, GlaxoSmithKline, has been asked by the FDA to reclassify the drug as a "Category D" drug for pregnant women, meaning that studies have shown a risk to fetuses who are exposed to the drug.

Women who are currently taking Paxil and are pregnant or planning to become pregnant should discuss their options with their medical providers.If you have suffered injury after taking Paxil, you may have a defective drugs case and should consult an attorney.

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