FDA approves Wyeth's oral contraceptive Lybrel

The Food and Drug Administration (FDA) announced on May 22 that Lybrel, the first low-dose oral contraceptive that eliminates monthly menstruation, is now approved for use in the US. Standard oral contraceptives consist of 21 pills containing the hormones estrogen and progestin, which prevent ovulation, followed by seven placebo pills that allow menstruation. The birth control pill was originally developed to mimic a normal menstrual cycle in the belief that women would find it more acceptable, not because it would be safer or more effective at preventing pregnancy. Taken 365 days a year, Lybrel continuously delivers lower doses of the synthetic hormones found in traditional birth control pills. It is designed for women who find their periods too painful, unpleasant or inconvenient and want to be free of them. According to Wyeth Pharmaceuticals, the company that manufactures Lybrel, the regimen is just as effective as other FDA-approved oral contraceptives. 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. But Lybrel has received mixed reviews from women and health experts. Based on clinical research, Wyeth found that 59 percent of women taking Lybrel stopped bleeding after six months. Eighteen percent of participants, however, dropped out of the clinical trials due to bleeding and spotting. Wyeth also found that interest in the pill depended on a woman's personal approach to monthly periods. Twenty-five percent of women surveyed by Wyeth said they were attached to their periods as a natural part of womanhood. Nearly two-thirds of women surveyed expressed an interest in eliminating their menstrual periods, although fifty percent of women said they welcomed their periods as an indicator that they were not pregnant. Because women taking Lybrel may not know whether they are pregnant, the FDA said that they should undergo pregnancy tests if they suspect they could be. Some experts questioned whether enough research had been done to be sure that Lybrel is safe to suppress menstruation in the long term. "There may be important health consequences that we don't know about," said Christine L. Hitchcock, an endocrinology researcher at the University of British Columbia. "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." Some also criticized Lybrel for fueling biases and misconceptions about menstruation. Ingrid Johnston-Robledo, an associate professor of psychology and women's studies at State University of New York, said that Lybrel "perpetuates a lot of negative attitudes and taboos about menstruation -- that it's something that's bothersome and dirty and debilitating and shameful." "I think it sends the wrong message about menstruation in women's lives, especially for young women," Johnaron-Robledo said. Wyeth expects to begin sales of Lybrel in July, but the price has not been determined, according to a spokesperson for the company. Linda Miller, an obstetrician-gynecologist at the University of Washington in Seattle, said that women can eliminate their periods more inexpensively by using generic versions of some birth control pills that have long been available. "You don't need a brand," said Miller, who counsels women about suppressing their periods through her Web site, NoPeriod.com.