FDA News

FDA Approves Wyeth's Oral Contraceptive Lybrel

(May 25, 2007)-- FDA has approved Wyeth's oral contraceptive Lybrel, which is designed to eliminate monthly menstrual periods, the Los Angeles Times reports. 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.

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. A European trial found that the drug prevented pregnancy in all 323 women who took it, according to Wyeth.

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.

Daniel Shames, deputy director of FDA's Center for Drug Evaluation and Research, said that eliminating monthly periods does not appear to carry safety issues, but he added that Wyeth will continue to study Lybrel to see if unexpected safety issues occur. FDA said that because women taking Lybrel will not have a monthly period, they should be tested if they suspect they might be pregnant, the Washington Post reports. Gerardo Bustillo, assistant ob-gyn chief at Orange Coast Memorial Medical Center, said Lybrel might appeal to women who take oral contraceptives to prevent menstrual cramps and migraine headaches or to control endometriosis. Wyeth expects to begin sales of Lybrel in July, but the price has not been determined, according to a spokesperson for the company.

Other experts questioned whether there has been enough research conducted on Lybrel's long-term effects. Christine Hitchcock, an endocrinology researcher at the University of British Columbia, said there might be "important health consequences that we don't know about," adding, "I don't think we understand everything that the menstrual cycle does well enough to say with confidence that you can abolish it and not have any consequences." Amy Alina of the National Women's Health Network said that although Lybrel could be a good alternative for some women, she is concerned that Wyeth is downplaying the number of women who experienced bleeding and spotting while taking the drug.

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