Washington – The first birth-control pill meant to put a stop to women’s monthly periods indefinitely 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 altogether when taken without break.
The pill isn’t for everyone, an FDA official said. About half the women enrolled in studies of Lybrel dropped out, said Dr. Daniel Shames, a deputy director in the FDA’s drugs office. Many did so because of the irregular and unscheduled bleeding and spotting that can replace scheduled menstruation.
“If you think you don’t want to go down this road, this is not for you,” Shames told reporters.
Wyeth plans to start Lybrel sales in July. The Madison, N.J., company said it hasn’t 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.
A women’s health expert said Lybrel would be a welcome addition for the woman who seeks relief from the headaches, tender breasts, cramps and nausea that can accompany monthly periods.
Whether Lybrel relieves those symptoms was not directly studied.
