SAFETY ALERT: FDA Releases Final Report Evaluating VTE-Risk with Drospirenone-Containing Contraceptives

The FDA has notified healthcare professionals that is has released the final report of the FDA-funded study that evaluated the risk of blood clots in users of several different hormonal contraceptives, with a focus on drospirenone-containing contraceptives. The FDA's review of the results of this study, specifically those results related to drospirenone, 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.

The FDA conducted this study in response to conflicting findings from six published epidemiologic studies that evaluated the risk of VTE in women using birth control pills containing drospirenone.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm.