Paxil Draws Heightened Warning

The Food and Drug Administration said Thursday that it was 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 have shown that the drug poses a risk to the fetus.

But the FDA said the benefits of the drug to the mother might outweigh the risk to the fetus.

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 heart’s chambers. Some were minor; others could require surgery.

The agency had issued a warning in September and expanded it when information from an additional study came in. Further studies are underway.

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.

Most of the heart defects reported in these studies were atrial and ventricular septal defects, which are holes in the walls of the heart chambers. In general, about 1% of babies develop such defects.

GlaxoSmithKline spokeswoman Gaile Renegar said the company was notifying doctors about the new information.

She said the company had not concluded that there was a definite, causal link between the drug and the increased incidence of birth defects. The company has previously cited another survey of births that it said did not note a comparable increase.