Reuters: Regulatory News: UPDATE 1-FDA says drospirenone may raise clot risk

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UPDATE 1-FDA says drospirenone may raise clot risk Apr 10th 2012, 18:19 April 10 | Tue Apr 10, 2012 2:19pm EDT April 10 (Reuters) - U.S. health regulators said women taking birth control pills containing the compound drospirenone may be at a higher risk of developing blood clots than those on progestin-containing pills. The U.S. Food and Drug Administration completed a review of two studies evaluating the risk of blood clots in women kast year, but did not reach a conclusion at that time. The FDA said it will add the information about the studies to the labels of drospirenone-containing birth control pills. Germany's Bayer AG's best-selling birth control drugs, Yaz and Yasmin, contain the compound. "The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products ... whereas other epidemiological studies found no additional risk," the FDA said in a statement. The regulator said women should consult their doctors about the risk of developing blood clots before deciding which birth control method to use.

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