Wednesday, May 23, 2007

PILL APPROVED TO HALT FEMALE PERIODS INDEFINITELY

WASHINGTON, May 22 (AP) — The first birth-control pill meant to put a stop to a woman’s monthly period indefinitely has won federal approval, the manufacturer said on Tuesday.

When taken daily, the pill, called Lybrel and made by Wyeth, can halt women’s menstrual periods indefinitely and prevent pregnancies.

It is the latest oral contraceptive approved by the Food and Drug Administration to depart from the 21-days-on, 7-days-off regimen that had been standard since birth-control pill sales began in the 1960s, and is the first made to put off periods altogether when taken without a break.

Wyeth, based in Madison, N.J., plans to start Lybrel sales in July. The company said it had not 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 American women taking birth-control pills do so to prevent pregnancy. Others rely on the hormonal contraceptives to control acne or regulate their monthly periods.

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

However, 18 percent of women dropped out of studies because of spotting and breakthrough bleeding, according to Wyeth.

Still, Dr. Vanessa Cullins, vice president for medical affairs at the Planned Parenthood Federation of America, said Lybrel would be welcomed by the woman seeking relief from the headaches, tender breasts, cramps and nausea that can accompany monthly periods.

Jean Elson, a University of New Hampshire sociologist, said the pill left her with mixed feelings.

“I certainly can understand the benefits of taking these kinds of medications, but for most women menstruation is a normal life event, not a medical condition. Why medicate away a normal life event if we’re not sure of the long-term effects?” said Ms. Elson, who researches medical sociology.

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