Drug Safety and Availability 2 > FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone

Safety Announcement [10-27-2011] The U.S. Food and Drug Administration (FDA) is continuing its review of the potential increased risk of blood clots with the use of birth control pills containing drospirenone.

FDA is releasing the final report of the FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Report: Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints [http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf ]. Preliminary results of the FDA-funded study were discussed in the previous Drug Safety Communication (DSC) on September 26, 2011.

FDA’s review of the results of this study, specifically those results related to drospirenone-containing birth control pills, will be presented and discussed at the joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011.

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