FDA: Paxil May Have Birth-Defect LinkSep 28, 2005 | AP The Food and Drug Administration is warning that a study has suggested that the antidepressant Paxil may be associated with birth defects.
Paxil's manufacturer, GlaxoSmithKline P.L.C., said it would include the results of the study in the drug's list of precautions.
A retrospective study found increased numbers of babies born with birth defects to women who were taking Paxil during the first trimester of pregnancy, as compared with women on other antidepressants, according to the FDA and the company, which has a U.S. headquarters in Philadelphia.
This included an increase in heart defects, according to a letter from GlaxoSmithKline to health-care professionals. The FDA released the letter yesterday.
The drug, which goes by the generic name paroxetine, is already classified as a "Category C" drug for pregnant women meaning comprehensive studies of its effects on a pregnancy have not been performed.
Doctors are advised "to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy. It is recommended that health-care providers discuss these latest findings as well as treatment alternatives, with their patients," GlaxoSmithKline said.
Based on the study, the company said it had not concluded there existed a definite, causal link between the drug and the increased incidence of birth defects. GlaxoSmithKline cited another survey of births that it said did not note a comparable increase.
Coincidentally, the FDA warning came on the second day of a three-day vigil by a handful of protesters outside GlaxoSmithKline's Center City offices. Those protesters have called on the pharmaceutical company to recall Paxil for safety reasons.
GlaxoSmithKline sold about $950 million of Paxil products last year.