• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

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

Listen to this Podcast

Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today's topic: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone. 

Beth Carr, a pharmacist in the Division, will provide you with additional information about this Communication.

Guest speaker: On October 27, 2011, the Food and Drug Administration issued a Drug Safety Communication informing healthcare professionals and the public that FDA is continuing its review of the potential increased risk of blood clots with the use of birth control pills containing drospirenone.

This update is in follow-up to the FDA Drug Safety Communication posted on September 26, 2011 entitled: Safety review update on the possible increased risk of blood clots with 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, also known as 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.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Follow us on Twitter @FDA_Drug_Info for up to the minute important drug information. Know the moment it happens.

 

 

Contact FDA

Toll Free
(855) 543-3784, or
(301) 796-3400
Human Drug Information

Division of Drug Information (CDER)

Office of Communications

Feedback Form

10001 New Hampshire Avenue

Hillandale Building, 4th Floor

Silver Spring, MD 20993