blood clots in women taking birth control pill containing drospirenone

The FDA has issued new information about this safety issue, see the FDA Drug Safety Communication issued on 4-10-2012.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. Here is the final study protocol of the FDA-funded study Addendum to FDA Briefing Information for the December 8, 2011 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.

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.

Related Information

• Report: Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints
• Addendum to Report: Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints
• Appendix A
• Appendix B
• Appendix C
• Appendix D
• Appendix E
• FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone
• FDA Drug Safety Podcast for Healthcare Professionals: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone
• Information about Drospirenone
• Final Study Protocol: Addendum to FDA Briefing Information for the December 8, 2011 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting

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