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FDA approves pill to halt periods

By ASSOCIATED PRESS
Published May 23, 2007


WASHINGTON - The first birth control pill meant to put a stop to women's monthly periods won federal approval Tuesday.

Called Lybrel, it's the first such pill to receive Food and Drug Administration approval for continuous use. When taken daily, the pill can halt women's menstrual periods indefinitely and prevent pregnancies.

Lybrel is the latest approved oral contraceptive to depart from the 21-days-on, seven-days-off regimen that had been standard since birth control pill sales began in the 1960s. The pill, manufactured by Wyeth, is the first designed to put off periods when taken without break.

The pill isn't for everyone, an FDA official said. About half the women in studies of Lybrel dropped out, said Dr. Daniel Shames, a deputy director in the FDA's drugs office. Many did so because of irregular and unscheduled bleeding and spotting that can replace menstruation.

Wyeth plans to start Lybrel sales in July. The Madison, N.J., company said it hasn't yet determined a price for the 28-pill packs. The pill contains a low dose of two hormones already widely used in birth control pills, ethinyl estradiol and levonorgestrel.

A study showed Lybrel was just as effective in preventing pregnancy as a traditional pill, Alesse, also made by Wyeth. However, since Lybrel users will eliminate their regular periods, it may be difficult for them to recognize if they have become pregnant, Shames said.

Most of the roughly 12-million American women who take birth control pills do so to prevent pregnancy. Others rely on hormonal contraceptives to curb acne or regulate their monthly periods.

With Lybrel, in one test, 59 percent of the women who took Lybrel for a year had no bleeding or spotting during the last month of the study. However, because of dropouts, that translates into only about one-third of all the women originally enrolled in the study, Shames said.

"Women who use Lybrel would not have a scheduled menstrual period, but will most likely have unplanned, breakthrough, unscheduled bleeding or spotting, " Shames said. The bleeding can last four to five days and may persist for a year, he later added. Women who take other low-dose pills have reported similar issues.

One doctor questioned whether enough research had been done to be sure it is safe to suppress menstruation long term.

"There may be important health consequences that we don't know about, " said Christine 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."

The company and FDA said there is no evidence of risks.

Information from the Washington Post was used in this report.