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Yaz, Yasmin Blood Clot Risk Prompts Push for Stricter Warnings

Dec 7, 2011 | Parker Waichman LLP

U.S. Food & Drug Administration (FDA)  reviewers are pushing for stronger blood clot warnings for Yaz, Yasmin, and other birth control pills that contain drospirenone.  In a report posted on the agency website yesterday, FDA reviewers said that evidence linking Yaz, Yasmin and similar oral contraceptives to an increased risk of blood clots is conflicting, but could not be ruled out.

The FDA report was released in advance of tomorrow's joint meeting for the FDA's Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.   The advisors will vote on whether to recommend new warnings for pills with drospirenone.

Yaz and Yasmin have been named in more than 10,000 lawsuits alleging Bayer AG neglected to appropriately warn patients and doctors about increased health risks associated with the drugs.  Thousands of those lawsuits have been consolidated the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100), currently pending before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.

The FDA has been reviewing Yaz and Yasmin for sometime, and over the last two years several large, independent studies have suggested the rate of blood clots with drospirenone-containing drugs is higher than with other hormone-based contraceptives. Last month, the agency reported its own study found that women who use such were 75 percent more likely to experience clots compared to those taking other oral contraceptives. Other studies reviewed by the agency have reached conflicting conclusions, with some pointing to higher risk, and others not.

However, two studies published in 2007, conducted as part of the postmarketing requirements of the FDA or European regulators, did not find any difference in blood clotting between drospirenone and levonorgestral.  Both of those studies were funded by Bayer.

In addition to Yaz and Yasmin, drospirenone is found in birth control pills sold under the names Ocella, Safyral, Syeda, Zarah, Beyaz, Gianvi, and Loryna.

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