FDA Strengthens Warning For Pregnant Women Using Paxil After Two Studies Link Use To Fetal Heart Defects

FDA on Thursday issued a public health advisory warning pregnant women and physicians about an increased risk of fetal heart defects from taking GlaxoSmithKline's antidepressant Paxil -- known generically as paroxetine -- during the first three months of pregnancy, the Washington Post reports (Kaufman/Vedantam, Washington Post, 12/9). The warning moves Paxil to Category D, FDA's second-highest category for risk of birth defects. Category D means that either "controlled or observational" studies of pregnant women "have demonstrated a risk to the fetus" (FDA release, 12/8). The advisory is based on preliminary results from two studies, which found that women taking Paxil during the first three months of pregnancy were 1.5 to two times as likely to give birth to an infant with a heart defect as women who took other antidepressants or none at all (Washington Post, 12/9).

Studies, Recommendations
The first study, an evaluation of U.S. health insurer data, found that about 2% of women who took Paxil early in pregnancy gave birth to infants with heart defects, compared to about 1% of all women. The other study, which examined data from about 6,900 infants in Sweden, found that 1.5% of women taking Paxil in their first trimester gave birth to infants with heart defects, compared to 1% of women who took other antidepressants (Richwine, Reuters, 12/8). Most of the heart defects reported in the studies were atrial and ventricular septal defects, or holes in the heart walls, which sometimes can require surgery and sometimes can resolve with no treatment (AP/South Florida Sun-Sentinel, 12/9). For women taking Paxil who plan to become pregnant or are three months pregnant or less, "[h]ealth care professionals should consider discontinuing [the drug] -- and switching to another antidepressant if indicated," FDA said in a release, adding, "In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising 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" (FDA release, 12/8). Before Thursday's advisory, Paxil had been classified as a Category C drug for pregnant women, which means comprehensive studies of its effects during pregnancy have not been performed (Kaiser Daily Women's Health Policy Report, 9/28).

Reaction
GSK spokesperson Gaile Renegar said that the studies are examinations of databases and not clinical trials (Reuters, 12/8). She added that the company is studying to see how and why Paxil might be causing any birth defects (Washington Post, 12/9). GSK has worked with FDA to make the labeling changes and to communicate the updated findings for Paxil so physicians and patients can make well-informed treatment decisions," Jack Modell, GSK vice president of clinical psychiatry, said (GSK release, 12/8). Kimberly Yonkers, a psychiatrist at Yale University School of Medicine, also noted the limitations of the two studies, adding, "Depression is still undertreated. Pregnant women in particular are immensely undertreated, and you worry about people being unduly frightened." Robert Temple, FDA's director of medical policy, said, "If you're on Paxil and pregnant, our advice is to talk to your physician and consider switching to a different drug," adding, "Abrupt withdrawal of Paxil has its own problems, but the clear suggestion here is that you might want to think about a change" (Washington Post, 12/9).

NBC's "Nightly News" on Thursday reported on the advisory. The segment includes comments from Lee Cohen, director of the perinatal and reproductive psychiatry clinical research program at Massachusetts General Hospital (Bazell, "Nightly News," NBC, 12/8). The complete segment is available online in Windows Media.


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