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FDA Approves 'No-Period' Contraceptive Pill
Lybrel may become popular with younger women, expert says
By E.J. Mundell
HealthDay Reporter
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TUESDAY, May 22 (HealthDay News) -- Lybrel, a birth-control pill that does away with a woman's monthly period, was approved Tuesday by the U.S. Food and Drug Administration.
The estrogen-progestin hormonal pill differs from traditional birth-control pills in that it does not include the "week off" of placebo pills that leads to a cessation of artificial hormones and bleeding.
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Lybrel is described as "continual contraception" but it "works the same way as the 21-days on, seven-days off [pill] cycle -- it stops the body's monthly preparation for pregnancy by lowering the production of hormones that make pregnancy possible," Dr. Daniel Shames, deputy director of the FDA's Office of Drug Evaluation III, at the Center for Drug Evaluation and Research, explained at a press conference late Tuesday.
A majority of women who decide to take Lybrel will encounter unscheduled bleeding, or spotting, that in most cases tapers off over the first year of use, Shames said. In the primary clinical trial leading up to approval, 59 percent of women who took Lybrel for one year reported no bleeding or spotting during the last month of the trial.
In terms of safety, two one-year clinical trials involving more than 2,400 18-to-49-year-old women showed no increased risk of endometrial cancer among those taking Lybrel. The risks of other side effects linked to the birth-control pill -- primarily blood clots -- were similar to those seen in other contraception regimens, Shames said.
"We don't expect any surprises in terms of long-term use of this product," he added, although he noted that the FDA has requested that the drug's maker, Wyeth Pharmaceuticals, conduct post-marketing studies to keep tabs on Lybrel's long-term safety.
Despite some women's reticence to do away completely with their monthly period, gynecologic experts agreed that there was no physiological "downside" to a period-free life. In fact, one expert noted that, for decades, many American women have been pharmaceutically ending their periods with more traditional birth-control pills with no resulting problems.
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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 5/23/2007
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SOURCES: Camelia Davtyan, M.D., associate professor, medicine, University of California, Los Angeles; Michael Petriella, M.D., vice chairman, department of obstetrics and gynecology, Hackensack University Medical Center, Hackensack, N.J.; May 22, 2007, teleconference with Daniel Shames, M.D., deputy director of the U.S. Food and Drug Administration's Office of Drug Evaluation III, at the Center for Drug Evaluation and Research
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