FDA Approves Wyeth's Oral Contraceptive Lybrel

Main Category: Women's Health / Gynecology
Also Included In: Sexual Health / STDs;  Pharma Industry / Biotech Industry
Article Date: 25 May 2007 - 1:00 PDT

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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).

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, 5/22).

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 (Corbett Dooren, Wall Street Journal, 5/23). 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 (Stein, Washington Post, 5/23). 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 (Los Angeles Times, 5/23). Wyeth expects to begin sales of Lybrel in July, but the price has not been determined, according to a spokesperson for the company (Rockoff, Baltimore Sun, 5/23).

Reaction
Amy Marren of Wyeth said that Lybrel will be a "great option" for women. Reproductive health advocates also welcomed Lybrel's approval and said it provides women with another option for contraception, the Post reports. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America, said, "Every woman's birth control needs are different, and the best methods are those that fit a woman's lifestyle and meet her needs."

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.

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" (Washington Post, 5/23).

Broadcast Coverage
Three broadcast programs on Tuesday reported on the Lybrel approval. Summaries appear below.

• ABC's "World News": The segment includes comments from Anne Davis of Columbia University Medical Center and a woman who participated in a study of the drug (Stark, "World News," ABC, 5/22). Video of the segment is available online.
  
  
• NBC's "Nightly News": The segment includes comments from Robert Barbieri of Brigham and Women's Hospital and Lee Shulman of the Department of Obstetrics and Gynecology at the Northwestern University's Feinberg School of Medicine (Snyderman, "Nightly News," NBC, 5/22). Video of the segment is available online.
  
  
• WBUR's "Here & Now": The segment includes a discussion with Tim Johnson, medical editor for ABC News ("Here & Now," WBUR, 5/22). Audio of the segment is available online.

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