Thursday, May 24, 2007
Oral contraceptive Lybrel, approved by FDA
FDA as expected on Tuesday approved Wyeth's oral contraceptive Lybrel, which is designed to eliminate monthly menstrual periods, the Los Angeles Times reports (Kaplan, Los Angeles Times, 5/23). 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 (Kaiser Daily Women's Health Policy Report, 5/22). A European trial found that the drug prevented pregnancy in all 323 women who took it, according to Wyeth (Los Angeles Times, 5/23).