On December 8, 2011, the FDA convened to review the conflicting data of numerous studies evaluating the risk of venous thromboembolic events (VTEs) associated with Yasmin, Yaz, and other combined oral contraceptives (COCs) that contain drospirenone (DRSP) as the progestin component. The FDA’s expert panel voted 21 to 5 that the current US labels for Bayer’s DRSP containing COCs are currently inadequate and need more information concerning the increased risk of blood clots compared to older contraceptive pills. The FDA’s own study found a 75% increase in the risk of blood clots in women using Bayer’s line of DRSP contraceptives.
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