Wyeth contraceptive that stops periods win U.S. OK

WASHINGTON (Reuters) - A birth-control pill that may eliminate a woman’s monthly menstrual period won U.S. approval on Tuesday, health officials said.

Lybrel, made by drugmaker Wyeth, is meant to be taken every day to indefinitely stop monthly menstrual bleeding and prevent pregnancy. It contains two hormones widely used in other oral contraceptives.

Wyeth said Lybrel should be available in pharmacies in July.

Traditional birth control pills are usually taken for 21 days followed by seven days of placebo pills or no pills, which allows a period of bleeding to occur.

For years, some women have been stopping their periods by taking birth control constantly without the break. Lybrel is the first, however, that is approved for that use.

It takes time, however, for periods to be suppressed, and most women will have intermittent bleeding or spotting during the first year of use, the U.S. Food and Drug Administration said.

“The convenience of having no scheduled menstruation should be weighed against the inconvenience of unscheduled bleeding or spotting,” an FDA statement said.

Wyeth studied more than 2,400 women ages 18 to 49. In the main study, 59 percent who took Lybrel for one year had no bleeding or spotting during the last month, the FDA said.

Bleeding and spotting may occur on four or five days each month, said Dr. Daniel Shames, deputy director of the FDA office that reviews contraceptives. It decreases over time for most women who stay on the drug for a year. About half of the women in Wyeth’s studies dropped out before that time, he said.

Dr. Amy Marren of Wyeth’s global medical affairs division said intermittent bleeding occurs mostly during the first three to six months of Lybrel use. Eighteen percent of women in studies dropped out because of bleeding, she said.

Major side effects such as blood clots and strokes in some women were similar to traditional birth control, the FDA said.

Vanessa Cullins, vice president for medical affairs at Planned Parenthood, welcomed Lybrel as a new option. She said the packaging of 28 active pills would make it more convenient for women who want to halt their periods.

“Women who have been presented with the option of extended hormonal use opt for and like it ... it’s turning out to be fairly popular,” she said.

But others have questioned the idea of eliminating a natural process because it may be inconvenient.

“Menstrual manipulation appears to be another in a long line of attempts to medicalize women’s natural biological life events,” said University of New Hampshire sociologist Jean Elson.

The FDA’s Shames said his agency was asking Wyeth to study long-term risks of suppressing menstruation. “We don’t expect there are going to be any surprises” that are different from other birth-control pills, he said.

Women should be aware that it may be difficult to tell if they become pregnant when taking Lybrel, and they should take a pregnancy test if they think they might be, the FDA said.

Wyeth said Lybrel should be available in pharmacies in July.

Some other birth control pills allow women to have periods less often than once a month. Barr Pharmaceuticals Inc.’s Seasonique, for example, cuts the number of menstrual periods from 12 to four a year.