Get ready for an ad blitz. On Tuesday, the FDA is expected to approve Lybrel, a Wyeth drug that’s designed to let women suppress monthly bleeding indefinitely, and the first birth control pill to be taken continuously, the Associated Press reports. The name, by the way, is supposed to evoke “liberty.”

Gynecologists say they’ve been seeing a slow but steady increase in women asking how to limit and even stop monthly bleeding. Surveys have found up to half of women would prefer not to have any periods, most would prefer them less often and a majority of doctors have prescribed contraception to prevent periods.

“I think it’s the beginning of it being very common,” says Leslie Miller, a University of Washington-Seattle obstetrician-gynecologist who runs a Web site focused on suppressing periods. “Lybrel says, ‘You don’t need a period.’”

While that can be done easily - sometimes more cheaply - by skipping sugar pills or replacing birth-control patches or vaginal rings sooner, doctors say the trend is fueled mainly by advertising for the new options. They expect plenty for Lybrel’s July launch, although Wyeth says it will market to doctors first.

Analysts have estimated Lybrel sales could reach $40 million this year and $235 million by 2010. US sales of Seasonique, launched last August, hit $6.1 million in the first quarter of 2007. Its predecessor Seasonale, which got cheaper generic competition in September, peaked at about $100 million. Yaz, launched last August, had first-quarter sales of $35.6 million; Loestrin 24, launched in April 2006, hit $34.4 million in the first quarter.

Still, some women raise concerns about whether blocking periods is safe or natural. Baltimore health psychologist Paula Derry wrote in an opinion piece in the British Medical Journal two weeks ago that “menstrual suppression itself is unnatural,” and that there’s not enough data to determine if it is safe long-term.

Sheldon Segal, a scientist at the nonprofit research group Population Council, wrote back that a British study found no harm in taking pills with much higher hormone levels than today’s products for up to 10 years. “Nothing has come up to indicate any unexpected side effects,” says Segal, who co-authored the book “Is Menstruation Obsolete?”

But Lybrel contains the lowest dose of two hormones widely used in birth-control pills, ethinyl estradiol and levonorgestrel. That might cause too much breakthrough bleeding, a problem with some newer pills with low hormone doses, says. Lee Shulman, a Chicago obstetrician-gynecologist who chairs the board of the Association of Reproductive Health Professionals.

In testing of Lybrel, 59 percent of women ended up with no bleeding after six months, but 18 percent of women dropped out of studies because of spotting and breakthrough bleeding, according to Wyeth. “You’re now basically trading scheduled bleeding for unscheduled bleeding, and I don’t know whether American women will buy into that,” says Shulman.

Source: Associated Press
[tags]Birth Control, Lybrel, Wyeth[/tags]