New birth control pill waits for approval
New York, April 20 (PTI): A birth control pill that would eliminate monthly menstruation till a woman takes it is expected to be approved by the American Food and Drug Administration next month.
The drug's maker, Wyeth, told the paper that it is expecting F.D.A. approval for the new pill called 'Lybrel'
in May, but declined to discuss its marketing plans.
Lybrel is an investigational combination low-dose oral
contraceptive designed to be taken daily, 365 days a year.
The company's research shows that nearly two-thirds of women it surveyed expressed an interest in giving up their periods. That dovetails with the findings of similar research conducted by Linda C. Andrist, a professor at MGH Institute of Health Professions in Boston, the paper says.
Doctors say they know of no extra risk, but New York Times reports that some women are uneasy about the idea.
"My concern is that the menstrual cycle is an outward sign of something that is going on hormonally in the body," Christine L. Hitchcock, a researcher at the University of British Columbia said.
She worries about "the idea that you can turn your body on and off like a tap."
That viewpoint, The Times says, is apparently one reason some already available birth control pills that can enable women to have only four periods a year have not captured a larger share of the oral contraceptive market.
But if the new pill, called Lybrel, is approved, analysts predicts an onslaught of advertising meant to persuade women to do just that.
Lybrel (90 mcg levonorgestrel/20 mcg ethinyl estradiol)
is a newly-approved contraceptive developed by Wyeth Pharmaceuticals. Lybel
is the first oral contraceptive to be administered 365 days per year, and
not in 28-day cycles like other oral contraceptives. The FDA approved Lybrel
for human consumption on May 22, 2007. Lybrel is expected to be made
available to the public in the United States by July 2007. Lybrel's major
attractive factor is that during the administration of Lybrel, women
experience no menstrual cycle and amenorrhea; and thus no menstrual cramps
or bleeding. Spot bleeding has been seen in 41% of women taking the pill in
studies, and has been shown to go down dramatically as time on the pill
progresses past the 3-month stage. 20% of women experienced spot-bleeding
not requiring any sanitary protection, while 21% experienced spot-bleeding
requiring sanitary protection.
Some nontraditional pills like Yaz and Loestrin 24 Fe shorten monthly
periods to three days or fewer. Seasonique, an updated version of Seasonale,
reduces periods to four times a year. With Lybrel, 59 percent of women who
took it in tests had no bleeding after six months.
