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FDA Calls for Clearer Risk Labeling for Yaz

Time,  Dec 9, 2011

An FDA panel has decided to update labeling on Bayer's popular Yaz and similar birth control pills to better reflect the higher risk of blood clots associated with these drugs compared with older oral contraceptives. After reviewing the medical evidence, the federal panel voted 21-5 on Thursday that labeling on Yaz, Yasmin, Beyaz, Safyral and its generic versions is inadequate and should be revised. The panelists said the label should make clearer the potential risk of blood clots in the legs and lungs from taking the pills, and that clots can be fatal. The labeling now only informs women about the conflicting studies on the blood-clot risks.

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