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FDA Study Sees Increased Blood Clot Risks with Yaz, Yasmin

Oct 28, 2011 | Parker Waichman LLP

Only days after a Danish study confirmed a higher risk of blood clots among women using birth control pills like Yaz and Yasmin, the U.S. Food & Drug Administration (FDA) announced its own study has reached similar conclusions.  According to the agency, women taking Yaz, Yasmin and other pills made with the synthetic progestin, drospirenone, had a 75 percent greater chance of experiencing venous thromboembolisms (VTEs) - a type of blood clot that forms in the legs and may travel to the lungs - compared to those using pills made with levonorgestrel.

The FDA-funded study involved a review of  the medical histories of more than 800,000 American women, all of whom were on some type of birth control between 2001 and 2008.

"If your birth control pill contains drospirenone, do not stop taking it without first talking to your health care professional," the FDA said in a statement released yesterday. "Contact your health care professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain or sudden shortness of breath. If you smoke and are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood."

On Tuesday, a separate study published in the British Medical Journal found drospirenone and other new-generation progestins double  the risk of blood clots compared to levonorgestrel.

The FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for December 8 to discuss the safety of drospirenone birth control pills.

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