The FDA asked manufacturer GlaxoSmithKline to reclassify the drug, which goes by the generic name paroxetine, as a "Category D" drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus. However, the FDA said, the benefits of the drug may outweigh the risk to the fetus.
Two studies of pregnant women taking Paxil during their first trimester have 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 Thursday. 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 people who are planning to become pregnant, unless there are no other options.