Product News and Recalls

FDA Panel: Yaz/Yasmin warnings inadequate, declines Yaz recall

FDA Advisory Panel Votes to Require Updated Warnings

On December 8, 2011, an FDA advisory panel held 9 hours of hearings about Yaz and Yasmin birth control and the risk of blood clots. Testimony included information about  several large, independent studies that showed an increased risk. The panel also heard from the family of a young woman who used another birth control for months with no problems. She switched to Yaz, and within two months she tragically passed away from a blood clot, on Christmas day.

The panel concluded, by a vote of 21-5, that the warnings should be changed to explain the increased risk. In other words, a panel of experts for the FDA decided that the warnings currently provided with Yaz and Yasmin are inadequate. Eleven experts also voted for a Yaz recall. They wanted to pull it from the market because they believed that the risks outweigh the benefits, given that there are other birth control pills that are at least as effective, but with lower risk. These 11 members were out-voted by the remaining 15, who decided that the benefits outweigh the risks. In other words,  a Yaz recall is not warranted even though there appears to be an increased risk.

Women across the country who suffered blood clots while on Yaz, Yasmin, Ocella or Gianvi, are suing to recover damages because they were not told they were increasing their risk of blood clots. Lopez McHugh represents a number of these women, and will evaluate your potential case for free, and help you attempt to recover. One of our cases has been nominated as a potential bellwether case–among a small group of cases that may be selected to be one of the first to go to trial, out of 5,000 to 6,000 cases across the country. If you suffered a blood clot, pulmonary embolism, or stroke while on Yaz, contact us to discuss your options for pursuing compensation, or have your questions answered by a qualified attorney, with no obligation.