FDA on Tuesday is expected to approve Wyeth's oral contraceptive Lybrel, which is designed to eliminate monthly menstrual periods, the AP/Chicago Tribune reports (Johnson, AP/Chicago Tribune, 5/18). Lybrel, which contains a lower dose of synthetic hormones in a daily dose than traditional oral contraceptives, is taken 365 days a year with no placebo pills. The usual regimen for oral contraceptives is 21 active pills taken consecutively, followed by seven placebo pills (Kaiser Daily Women's Health Policy Report, 12/22/06). According to Wyeth, 59% of women taking Lybrel stopped bleeding after six months, but 18% of women participating in a clinical trial dropped out because of bleeding or spotting (AP/Chicago Tribune, 5/18).

The drug has received mixed reviews from women and health experts. In a study conducted by Wyeth, nearly two-thirds of women expressed an interest in eliminating their menstrual periods. However, Wyeth research also found that nearly 50% of the women surveyed welcomed their periods as a sign that they were not pregnant and nearly 25% said they were attached to their periods as a natural part of womanhood. Available medical research shows that the side effects of pills that suppress menstruation are similar to those of other birth control pills. The most significant risk of the pills is cardiovascular complications in women who smoke (Kaiser Daily Women's Health Policy Report, 4/20).

According to the AP/Tribune, Wyeth is expected to launch the drug in July. Wyeth has said it will first market Lybrel to physicians, the AP/Tribune reports (AP/Chicago Tribune, 5/18).

CBS' "Evening News" on Monday reported on Lybrel. The segment includes comments from Linda Andrist of the Institute of Health Professions at Massachusetts General Hospital, Anne Davis of New York Presbyterian Hospital and women who have taken Lybrel (Miller, "Evening News," CBS, 5/21). Video of the segment and expanded CBS News coverage are available online.