WASHINGTON (AP) â" Federal health regulators are disposition toward adding new information about a risk of blood clots to a labels of widely prescribed birth control pills such as Yaz, in light of flourishing justification that a newer contraceptive drugs might be riskier than comparison drugs.
In papers expelled Tuesday, a Food and Drug Administration pronounced there is opposing justification about a risk, yet that a information should seem in labeling used by doctors and patients.
"We trust that, since of a coherence in new reports for an increasing risk, product labeling should simulate that really genuine possibility," state a lecture papers from FDA scientists.
On Thursday, a FDA will ask a row of outward experts to import in on a emanate and to cruise either some women should not take a drugs. The group is not compulsory to follow a panel's advice, yet it mostly does.
Yaz and several other pills enclose a manmade hormone called drospirenone that was heavily marketed as carrying fewer side effects than progressing drugs.
But over a final dual years several large, eccentric studies have suggested a rate of blood clots with drospirenone-containing drugs is somewhat aloft than with other hormone-based contraceptives. The many new research by FDA estimates that 10 in 10,000 women on a newer drugs will knowledge a blood clot per year, compared with 6 in 10,000 women on comparison contraceptives.
Studies conducted by German drugmaker Bayer, that markets Yaz and associated tablet Yasmin, found no increasing risk of blood clots. Sorting out a blood clot risk of birth control drugs is generally formidable since all hormone-based drugs boost a risk of clotting. Further complicating a emanate is that clots can be caused by lifestyle factors such as smoking, plumpness and family history.
FDA scientists contend nothing of a existent studies yield a decisive answer and that new studies are needed.
"The whole physique of studies provides opposing justification that can't be simply reconciled by any singular disproportion among studies," states a agency's review.
Looking opposite a half-dozen studies available, FDA scientists contend a risk of blood clots appears many expected in a initial 3 to 6 months holding a drug, and increases among comparison women.
Most birth control drugs use a multiple of dual womanlike hormones, estrogen and progestin, to stop ovulation and thicken cervical mucus, that helps retard sperm. For decades many women have reported bloating and mood swings as side effects.
Introduced in 2001, Yasmin was a initial birth control pill to use a new form of progestin called drospirenone, that seemed to have fewer side effects. The reformulated chronicle of a drug, Yaz, was authorized in 2006 with new claims on a tag that it decreased acne and a critical form of mood disorder. With a slogan, "beyond birth control," Bayer's advertisements pitched Yaz to women in their 20's as an choice to comparison generations of contraceptives. One advertisements featured immature women singing a Twisted Sister anthem, "We're Not Gonna Take It," while popping balloons labeled "moodiness," ''bloating" and "acne."
Within dual years, Yaz had grown into a best-selling birth control tablet in a U.S. with rise sales of $781 million in 2009, according to information from IMS Health. But sales plummeted some-more than 50 percent a following year after a association was forced to run visual TV and repository advertisements. The FDA pronounced a company's commercials suggested Yaz could provide premenstrual syndrome. In fact, a drug has usually been shown to diminution occurrence of a most some-more critical mood commotion called premenstrual dysphoric disorder. Additionally, a FDA pronounced Bayer's commercials used distracting song and visuals to downplay a drug's list of side effects.
In a initial half of this year, Yaz ranked fourth among preventive pills sole in a U.S., behind Warner Chilcott's Loestren, Johnson & Johnson's Ortho Tri-Cyclen and a general chronicle of Yaz marketed by Teva Pharmaceuticals, according to IMS Health.
Newer drugs like Yaz are no some-more effective than comparison pills, generally permitting one random pregnancy per year for each 100 women.
News referensi http://news.yahoo.com/fda-favors-more-risk-birth-control-pills-141525325.html
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12:39 PM Saturday, December 24, 2011