Safety Announcement
[05-31-2011] The U.S. Food and Drug Administration (FDA) is informing the public about new information that is being assessed as part of FDA's ongoing safety review of birth control pills that contain drospirenone. This review will further evaluate the risk of blood clots in women who use these products.
Two recently published studies reported a greater risk of blood clots for women taking birth control pills containing drospirenone as compared to the risk in women taking birth control pills containing another progestin known as levonorgestrel.
Previously published studies have also addressed the risk of blood clots in women using birth control pills containing drospirenone. These studies had conflicting findings--two postmarketing studies required by the FDA or European regulatory agencies did not report any difference in the risk of blood clots between drospirenone-containing products and products containing levonorgestrel or other progestins.4,5 Two other publications in 2009, however, reported that the risk of blood clots is higher in women using drospirenone-containing products than in women who use levonorgestrel-containing products.
Information from these latter four studies is already presented in the Warnings and Precautions section of current labels for drospirenone-containing birth control pills. An additional large study exploring the association of blood clots with hormonal contraception has been commissioned by FDA, and results of that study are currently being finalized and reviewed.
The European Medicines Agency (EMA) announced on May 27, 2011, that it is updating the product information on oral contraceptives containing drospirenone and ethinyl estradiol regarding the risk of venous thromboembolism after review of all available data, including the same newly published data FDA is reviewing.
The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available.
To Learn More:
Drug Safety Communication: http://www.fda.gov/Drugs/DrugSafety/ucm257164.htmFDA Office of Women's Health www.fda.gov/womens
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U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420
