Period-eliminating pill OK’d

Published 9:00 pm Tuesday, May 22, 2007

WASHINGTON – The Food and Drug Administration on Tuesday approved the first birth control pill that eliminates a woman’s monthly period.

Taken daily, the contraceptive, called Lybrel, continuously administers slightly lower doses of the same hormones in many standard birth control pills to suppress menstruation. It is designed for women who find their periods too painful, unpleasant or inconvenient and want to be free of them.

“This will be the first and only oral contraceptive designed to be taken 365 days a year, allowing women to put their periods on hold,” said Amy Marren of Wyeth Pharmaceuticals, which expects Lybrel to be available with a prescription by July. Wyeth has not yet set a price for Lybrel.

Company studies showed that Lybrel is as effective at preventing pregnancy as standard birth control pills, and Lybrel eliminated bleeding in the 59 percent of women who took it for a full year.

However, because of dropouts, that translates into only about one-third of all the 2,400 women originally enrolled in the study, the FDA said, and others experienced sporadic bleeding.

Some experts questioned Lybrel’s benefits.

“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,” said Christine Hitchcock, an endocrinology researcher at the University of British Columbia.

Wyeth and the FDA said that there is no evidence of any long-term risks and that suppressing the menstrual cycle can have many benefits, especially for women who experience cramps, bloating and mood swings.

There is no reason to think it would pose any additional health hazards, they said.

Amy Alina of the National Women’s Health Network said she is concerned that the company is playing down the number of women who still experience bleeding while taking Lybrel.

“You still have bleeding, but you just don’t know when it’s going to happen,” she said.

Standard oral contraceptives consist of 21 pills containing the hormones estrogen and progestin, which prevent ovulation, followed by seven dummy pills that allow menstruation.

The birth control pill was originally developed to mimic a normal cycle in the belief that women would find it more acceptable, not because it would be safer or more effective at preventing pregnancy.