Drug Safety and Availability > FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone

FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone

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.

Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones--estrogen and progestin. Birth control pills work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus to prevent pregnancy.

All birth control pills pose a risk of blood clots. Several epidemiological studies have reported that the risk of blood clots for women who use birth control pills containing drospirenone is higher than that for women who use birth control pills containing the progestin levonorgestrel. Other studies have not reported an increase in risk.

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.


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Drug Safety and Availability > FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone