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New Pill to Suppress Menstrual Bleeding Indefinitely

by Gopalan on  May 20, 2007 at 11:22 AM Drug News   - G J E 4
New Pill to Suppress Menstrual Bleeding Indefinitely
The liberated woman is certainly looking for ways and means of limiting or even stopping altogether monthly bleeding. Only the regimen available is a bit complicated.
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Offering a way out Wyeth, US drug manufacturers, have come out with Lybrel and the Food and Drug Administration (FDA) is expected to announce its approval Tuesday.

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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. It can be taken continuously.

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.'"

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 non-profit 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.

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 1% 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. Dr. Amy Marren, director of clinical affairs for Wyeth Pharmaceuticals. 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.

Breakthrough bleeding is bleeding while taking the active pills of combined oral contraceptives, or other hormonal contraceptives. The bleeding is usually light, often referred to as "spotting," though a few women may experience heavier bleeding. Breakthrough bleeding is most common when a woman first begins taking oral contraceptives, or changes from one particular oral contraceptive to another, though it is possible for breakthrough bleeding to happen at any time. Smokers are especially prone to breakthrough bleeding while taking oral contraceptives; though many users experience breathrough bleeding in the first three cycles of taking the Pill, non-smokers tend to see the bleeding dissipate more quickly than smokers.

Many women find that the breakthrough bleeding ceases after one or two cycles. Breakthrough bleeding that does not resolve on its own is a common reason for women to switch to different Pill formulations, or to switch to a non-hormonal method of birth control.

Breakthrough bleeding is most commonly caused by an excessively thick endometrium (uterine lining). This is not a dangerous condition, though the unpredictable and often lengthy periods of bleeding are unpleasant for the woman. Breakthrough bleeding may also be caused by hormonal side effects of ovulation. If the Pill is not suppressing ovulation, the woman is at high risk of pregnancy. Breakthrough bleeding may also itself be a symptom of pregnancy (contraceptive failure).

In testing of Lybrel, 59% of women ended up with no bleeding after six months, but 18% 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.

Source: Medindia
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Some News this. Lybrel, a name meant to evoke "liberty," may herald a new era of sex equality. Wonder how this tinkering of nature is likely to affect women's health in the long term. We certainly are getting bolder with accepting the unaccepted.
sunny1 Sunday, May 20, 2007

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