The U.S. Food and Drug Administration (FDA) has completed an observational study regarding the risk of blood clots in women using drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone progesterone. Based on this study, the FDA has determined that birth control pills containing drospirenone may be connected with a greater risk for development of blood clots than those containing progestin.
As a result of the recent study, drug labels for drospirenone containing birth control pills, including Yasmin, Yaz, Ocella, Safyral, and Beyaz, will be revised to report that these contraceptives may pose triple the risk for development of blood clots. The label change also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.
The study resulted from a joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and Drug Safety and Risk Management Committee in December 2011. Previously, the FDA had issued a Drug Safety Communication on May 31, 2011 based on preliminary results of an FDA funded study that suggested a 1.5 fold increase in the risk of blood clots in women who use drospirenone-containing contraceptives compared to users of other hormonal contraceptives.
The recent study evaluated only drospirenone-containing products that combine 3 mg. of drospirenone with 0.03 mg of ethinyl estradoil (an estrogen). It is unknown whether these results apply to other drospirenone-containing products with a lower concentration of estrogen.
Source: U.S. Food and Drug Administration, “FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone,” April 10, 2012.