The organization advises health care professionals to discuss this potential risk with women who plan to become pregnant or are in the first three months of pregnancy. Health care professionals should consider discontinuing Paxil and switching to another antidepressant in these patients. But for some women who have already been taking Paxil, the benefits of continuing the drug may be greater than the potential risk to the fetus.
"Stopping these medicines on your own can sometimes create more problems than it solves," says Sandra Kweder, MD, 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 Paxil's manufacturer, GlaxoSmithKline (GSK) of Research Triangle Park, N.C., to change the drug's pregnancy category from C to D, which is a stronger warning. Category D means that studies in pregnant women have demonstrated a risk to the fetus.
GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has been changed to reflect the latest data. Visit www.fda.gov/cder/drug/advisory/paroxetine200512.htm for more information.