Paxil poses risk to fetus, FDA stresses

WASHINGTON (AP) -- The Food and Drug Administration is strengthening its warning that the antidepressant Paxil may be associated with birth defects when it is taken during the first trimester of pregnancy.
The FDA and GlaxoSmithKline have reclassified 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 that the drug poses a risk to the fetus.
But the FDA said the benefits of the drug to the mother may outweigh the risk to the fetus.
Heart defects
Two studies of pregnant women who were taking Paxil during their first trimester have shown that their babies have heart defects at a rate that is as much as twice the norm, the FDA said.
The defects are most often holes in the walls of the chambers of the heart. Some were minor; others could require surgery.
The agency announced the strengthened warning Thursday. It issued a previous warning in September and expanded it when information from an additional study came in. Further studies are under way.
The FDA is advising doctors not to prescribe Paxil to women who are in their first three months of pregnancy or to women who are planning to become pregnant, unless there are no other options.
Women who are taking Paxil should talk to their doctor before going off the drug, the FDA said.
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