FDA Study Finds Increased Risk for Blood Clots with Drospirenone-Containing Contraceptives

Washington, DCThe US Food and Drug Administration (FDA) has issued a statement telling the public that drospirenone-containing birth control pills remain under safety review. The specific concern with these birth control pills, which include Bayer's Yaz/Yasmin, is increased risk for blood clots.

In order to better evaluate the risk associated with drospirenone-containing oral contraceptives, the 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.

The FDA advisory, released September 26th, states "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."

Approved oral contraceptives containing drospirenone are: Gianvi, Loryna, Beyaz, Zara, Syeda, Safyral, Ocella, Yaz/Yasmin and Drospirenone and ethinyl estradiol.