Drospirenone-Containing Birth Control Pills
June 1, 2011
FDA is reviewing conflicting clinical trial results from several oral contraceptive studies involving the progestin drospirenone. Patients taking birth control products containing drospirenone (ie Yaz, Gianvi, Loryna, Yasmin, Ocella, Syeda, Zarah, Beyaz, Safyral) may be at increased risk of developing blood clots compared to those patients taking birth control containing the progestin levonorgestrel. In two case-control studies published in the British Medical Journal, the risk of venous thromboembolic events (VTE) was approximately 2 – 3 times greater with drospirenone-containing contraceptives. Data were taken from US (Odds Ratio 2.3; 95% CI 1.6 to 3.2) and UK (Odds Ratio 3.3; 95% CI 1.4 to 7.6) databases. Two other studies published in 2009 contained data outlining similar risks with drospirenone; however, two postmarketing studies did not find a difference in VTE risk between drospirenone and levonorgestrel contraceptives.
FDA is reviewing data from all of these studies in order to determine the risks associated with the drospirenone-containing contraceptives. FDA will also review data from another study containing over 800,000 US women. This study was designed to assess the thrombotic and thromboembolic risk associated with several hormonal contraceptives. Data from this study are expected by late summer, 2011. FDA is not taking action until the review of data is complete. The European Medicines Agency (EMA) is adding additional warnings to product labeling based on these data.
Patients should continue using oral contraceptives containing drospirenone unless otherwise directed by their healthcare provider. Educate patients on the signs and symptoms of deep vein thrombosis and pulmonary embolism. These include leg pain, chest pain, and shortness of breath. Report any adverse events to the MedWatch program. Additional information is available at the following links:
- MedWatch Alert:
- Drug Safety Communication:
- Questions and Answers Surrounding Drospirenone:
- British Medical Journal case-control studies (University of Utah Campus only):
June 1, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.