FDA Drug Safety Communication

This update is in follow-up to the FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone on 5/31/2011.

FDA is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 20112. FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.

Given the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study, FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills.

Healthcare Professionals should:

- Consider the risks and benefits of drospirenone-containing combination oral contraceptives for a specific patient in light of her risk for developing blood clots (venous thromboembolism, VTE) before prescribing a drospirenone-containing oral contraceptive.

- Counsel patients about the current information regarding the risk of VTE with drospirenone-containing oral contraceptives compared to levonorgestrel-containing oral contraceptives.

- Factors for increased risk of VTE in users of birth control pills include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of combination oral contraceptives.

- The studies assessing the risk of blood clots have evaluated only the specific drospirenone-containing product that combines 3 mg of drospirenone with 0.03 mg of ethinyl estradiol (an estrogen). It is not known whether these study results apply to other drospirenone-containing products.

View the full FDA Drug Safety Communication on FDA.gov