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FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth contr

Posted Oct 28 2011 8:19am

This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/2011: 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 . 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.

Persons with disabilities having problems accessing the PDF files may call (301) 796-3634 for assistance.


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