www.msnbc.msn.com/id/18745930
TRENTON, NJ - 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. The US Food and Drug Administration is expect to announce approval Tuesday for Lybrel, a drug from Wyeth which would be the first pill to be taken continuously. 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 Web site focused on suppressing periods. "' 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 Madison, NJ-based Wyeth says it will market to doctors first. Analysts have estimated Lybrel sales could reach $40 million this year and $235 million by 2010. Predecessor Seasonale, which got cheaper generic competition in September, peaked at about $100 million. nature 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. New hormonal contraceptives on the US market give women multiple ways to skip or shorten their periods: --Seasonique comes in packs with 84 active birth control pills and seven dummy pills, so it limits periods to every three months. Launched last August, it works the same as predecessor Seasonale, which got cheaper generic competition in September. of Woodcliff Lake, NJ, Seasonique adds estrogen to the dummy pills to reduce breakthrough bleeding and menstrual symptoms. Launched last August, it offers shorter, lighter "periods," milder cramps and prevention of severe PMS --Loestrin 24, launched in April 2006, also has 24 active pills and four blank ones. of Rockaway, NJ, it can shorten periods to three days or less and reduce the level of bleeding. Approved last July, it works for up to three years and contains only progestin, an option for women avoiding estrogen for medical reasons. of Roseland, NJ, says it has sold 32 million units worldwide so far. Some older methods also can eliminate periods: --Mirena, also made by Bayer, is an intrauterine device that prevents pregnancy for up to five years, reduces monthly bleeding by 90 percent in most women and eliminates bleeding in about 20 percent after a year. Bayer is testing another oral contraceptive with an extended, flexible dosing schedule and Duramed is developing a lower-estrogen version of Seasonique. Associated Press 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 10 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. Mindy Wiser-Estin, an obstetrician-gynecologist in Little Silver, NJ, 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 1 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," Wiser-Estin said. Barr Pharmaceuticals of Woodcliff Lake, NJ, 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. "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.
In sync: Readers share stories of shared periods Marren said 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, 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," Shulman said. This material may not be published, broadcast, rewritten or redistributed.
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