FDA to Convene Panel to Weigh Risks of Yasmin and Yaz

On September 26, 2011 the FDA issued a Drug Safety Communication regarding its safety review of drospirenone-containing oral contraceptives such as Yasmin and Yaz. The FDA bulletin states that while the FDA has not reached a definitive conclusion, it "remains concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills".

The FDA has reviewed two 2011 studies that evaluated the risk of blood clots for women taking Yasmin/Yaz and is also continuing to review a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products. Preliminary results of the FDA-funded study show an approximately 1.5-fold increase in the risk ofvenous thromboembolism for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.

Because there is some conflict in the findings of the six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study, the FDA has planned a joint meeting of the Reproductive Health DRugs Advisory Comittee 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."

The FDA advises health care providers to inform their patients of the potential risk for blood clots of drospirenone-containing birth control pills such as Yasmin, Yaz and Ocella.