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Early results of new studies for Paxil (paroxetine) suggest that the drug can increase the risk of birth defects, in particular heart defects, when women take it during the first trimester of pregnancy. Paxil is approved to treat depression and other various psychiatric disorders. The FDA is currently gathering additional data and they are waiting for final results of the studies so they can better understand the higher risk of birth defects.

The FDA is advising health care professionals to discuss the potential risk with women whom plan to become pregnant or that are pregnant and in their first trimester. Health care providers may want to consider discounting Paxil and switching to another antidepressant for these patients. For women that have been taking Paxil already, the benefits of continuing drug use may be greater than the potential risk.

“Stopping these medicines on your own can sometimes create more problems than it solves,” says Sandra Kweder, M.D., deputy director of the FDA’s Office of New Drugs. “A lot of these medicines are associated with withdrawal syndromes, which can be very problematic for many patients, so stopping is something that needs to be monitored carefully by your doctor.”

The FDA advises health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.

Early results of two studies indicate that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received
other antidepressants or women in the general population. Most of the heart defects reported in these studies were holes in the walls of the chambers of the heart (atrial and ventricular septal defects).

The FDA has asked GlaxoSmithKline (GSK), Paxil’s manufacturer, to change the drug’s pregnancy category from C to D which is a stronger warning. Category D means that studies in pregnant women has shown a potential risk to the unborn fetus.

GSK updated the drug’s labeling in September 2005 to include data from one study. As additional data has become available, the labeling has been changed to reflect the latest data.

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