[09-26-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 2011. FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.
"It is unknown at this time whether the reported VTE risk applies to all drospirenone-containing products," the FDA indicated. Drospirenone-containing products with the higher estrogen dose include Yasmin, Zarah, Syeda, Safyral, and Ocella. Those with the lower amount of estrogen include Yaz, Loryna, Gianvi, and Beyaz.
Given the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study, FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills.
In the meantime, the agency advised health professionals to inform women taking drospirenone-containing products of the potential clotting risk. Smoking, being overweight, and having a family history of clotting disorders are all risk factors for VTE that should be discussed with patients, the agency noted.
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