The first birth-control pill meant to put a stop to women’s monthly periods indefinitely has won federal approval. Called Lybrel, it’s the first such pill to receive FDA approval for continuous use and, when taken daily, the pill can halt women’s menstrual periods indefinitely and prevent pregnancies.

The approval had been widely expected as Lybreal becomes 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 Wyeth pill is the first designed to put off periods altogether when taken without break.

Wyeth plans to start Lybrel sales in July, although the drugmaker says it hasn’t yet determined a price. The pill contains a low dose of two hormones already widely used in birth-control pills, ethinyl estradiol and levonorgestrel.

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

Some nontraditional pills such as Yaz and Loestrin 24 shorten monthly periods to three days or less. Seasonique, an updated version of Seasonale, reduces them to four times a year. With Lybrel, in tests, 59 percent of women who took the medication had no bleeding after six months.

However, 18 percent of women dropped out of studies because of spotting and breakthrough bleeding, according to Wyeth. That sort of unanticipated and irregular bleeding can be a problem with low-dose pills.

Still, 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.

“Over time she will experience markedly less bleeding episodes or no bleeding episodes. That is very beneficial for some women — and is wanted by some women,” says Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America.

Source: The Associated Press;
FDA statement;
Bloomberg News.

[tags]Lybrel, Oral Contraceptives, Wyeth[/tags]