FDA Requires Stronger Warning on Paxil

The Food and Drug Administration (FDA) is requiring a stronger warning that the antidepressant Paxil may be associated with birth defects. A second study found increased risk of fetuses developing heart defects when their mothers took Paxil during pregnancy.

The FDA asked manufacturer GlaxoSmithKline PLC to reclassify the drug as a ``Category D'' drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus.

Two studies of pregnant women taking Paxil during their first trimester have now shown their babies have heart defects one and a half to two times a greater rate than the norm, the FDA said. The agency announced the strengthened warning on December 8th. It issued a previous warning in September.

The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or women who are planning to become pregnant, unless there are no other treatment options. (from Associated Press news report)