FDA Approves Period Suppression Pill

TRENTON, N.J. (AP) — Women looking for a simple way to avoid their menstrual period could soon have access the first birth control pill designed to let women suppress monthly bleeding indefinitely.

A product called Lybrel received Food and Drug Administration approval this week, becoming the latest approved oral contraceptive to depart from the traditional 21-days-on, seven-days-off regimen that has been standard since first birth control pills were sold in the 1960s. But the Wyeth pill is the first designed to be taken continuously.

Lybrel contains the lowest dose of two hormones widely used in birth-control pills, ethinyl estradiol and levonorgestrel. Taking the pill daily would let women suppress their monthly bleeding indefinitely. However, unanticipated breakthrough bleeding may occur in some women.

Wyeth plans to start sales in July. The Madison, N.J., company declined to say what it would cost.

Most of the roughly 12 million US women who take the pill do so to prevent pregnancy. But others rely on hormonal contraceptives to curb acne or regulate their monthly periods.

Lybrel, a name meant to evoke “liberty,” would be the fourth new oral contraceptive that doesn’t follow the standard schedule of 21 daily active pills, followed by seven sugar pills — a design meant to mimic a woman’s monthly cycle. Among the others, Yaz and Loestrin 24 shorten monthly periods to three days or less and Seasonique, an updated version of Seasonale, reduces them to four times a year.

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,” said Dr Leslie Miller, a University of Washington-Seattle obstetrician-gynecologist who runs a website focused on suppressing periods. “Lybrel says, ‘You don’t need a period.’”

While that can be done easily — sometimes more cheaply — by skipping the 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.

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 S. 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 J. 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 ten years.

“Nothing has come up to indicate any unexpected side effects,” said Segal, who co-authored the book Is Menstruation Obsolete?

Most doctors say there’s no medical reason women need monthly bleeding and that it triggers health problems from anemia to epilepsy in many women. They note women have been tinkering with nature since the advent of birth control pills and now endure as many as 450 periods, compared with 50 or so in the days when women spent most of their fertile years pregnant or breast-feeding.

Dr Mindy Wiser-Estin, an obstetrician-gynecologist in Little Silver, N.J., has long advocated menstrual suppression.

She has seen a big increase in the last year in patients asking about it, but has one concern that leads her to encourage younger women to take a break every 12 weeks. About one percent of oral contraceptive users become pregnant each year, and young women taking continuous pills who have never been pregnant may not recognize the symptoms, she said.

“They may not know it in time to do something about it,” Dr Wiser-Estin said.

Barr Pharmaceuticals of Woodcliff Lake, N.J., whose subsidiary Duramed already is developing a lower-estrogen version of Seasonique, said its research with consumers and health care providers indicates they feel four periods a year is optimal, said spokeswoman Amy Niemann.

Wyeth obviously thinks otherwise.

“It allows women to put their menstrual cycle on hold” and reduces 17 related symptoms, from irritability to bloating, based on one small study, said Dr Amy Marren, director of clinical affairs for Wyeth Pharmaceuticals.

That might cause too much breakthrough bleeding, already a problem with some newer pills with low hormone doses, said Dr 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,” Dr Shulman said.