More Detail on Risk Urged for a Contraceptive Label

On December 8, 2011, the New York Times published an article noting the results of a recent U.S. Food and Drug Administration (F.D.A.) hearing on the popular birth control pills, Yaz and Yasmin, both manufactured by Bayer. The F.D.A.’s advisory committee discussed studies that provide conflicting evidence on the incidence of blood clotting events in women taking these drospirenone-based oral contraceptives. Recent studies have indicated that drospirenone, a synthetic version of the hormone progestin found in Yaz and Yasmin, may raise a woman’s risk of developing blood clots, which can lead to serious health problems. However, studies funded by Bayer have not found this increased level of incidence for blood clotting in women taking Yaz or Yasmin.

In light of these conflicting studies, the advisory committee recommended changing the product labeling for these oral contraceptives. The committee agreed that the labeling should include a warning about the conflicting evidence that exists regarding possible blood clotting in women who use these pills. The new product labeling will inform women of the possible risk for blood clots when taking Yaz or Yasmin. Although the committee found a change in product labeling necessary, it still felt that the benefits provided by these oral contraceptives outweigh the risks.

Recent lawsuits brought against Bayer, the company that manufactures both Yasmin and Yaz, claim that multiple women were harmed by taking these oral contraceptives. These lawsuits connect these birth control pills to approximately 100 deaths, according to court documents. Plaintiffs in these lawsuits also accuse Bayer of knowingly concealing unfavorable blood clot data results from the F.D.A. in 2004.

See the full New York Times article at:

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