The FDA has given its green light to the commercialization of Lybrel, the first birth control pill suppressing menstrual cycles of women.
FDA, U.S. Agency for regulation of drugs and food, gave the green light to the commercialization of Lybrel, the first birth control pill suppressing menstrual cycles of women. "The safety and efficacy of Lybrel (manufactured by the American laboratory Wyeth) as a contraceptive method is based on two clinical trials conducted each year on more than 2,400 women aged 18 to 49 years," says FDA (Food and Drug Administration), in a statement.
"The women using Lybrel will not have menstrual cycles, but will likely have bleeding or unexpected losses," warns the federal agency. However, after one year, the discharge frequency of bleeding, and the place of women, has organized the Year Lybrel from clinical trials, 59% of the women in the study, in the last month that bleeding, FDA says.
Lybrel has the same dangers as conventional birth control pills as an increased risk of blood clots, heart attack and stroke. The Lybrel is accompanied by a warning against the increased risk of serious cardiovascular side effects for women who smoke because of the combination of the hormones estrogen and progesterone in the pill. The Lybrel is sold in packs of 28 pills containing all combinations of low doses of progesterone (90 micrograms) and estrogen (20 micrograms), which are also used in other contraceptives taken orally. But unlike other pads 28 days, Lybrel does not include a placebo for four to seven days of the menstrual cycle. Women therefore continue to take a contraceptive during this period.
23 To the extent that this pill eliminates menstrual cycles, women may have difficulty recognizing the signs of pregnancy is also recommended that the FDA tests for doubt. Placing on the market seems Lybrel meet strong demand from women, according to gynecologists citing surveys that up to 50% of women surveyed wanted to have no monthly cycles. However, women are wondering if the Blocking cycles presents no health risks. The American psychologist Paula Derry in Baltimore (Maryland,) wrote in an editorial published in early May in the British Medical Journal that "the suppression of menstruation is not natural." She also noted that there was insufficient data to determine whether it presented no risks over the long term.
According to industry analysts, pharmaceutical, Lybrel could generate $ 40 million in 2007 sales for Wyeth and 235 million annually by 2010. Wyeth is headquartered in Philadelphia, Pennsylvania.
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