Yaz Birth Control Lawsuit - Consumer Drug Report
FDA advisory panel under scrutiny for voting against Yaz® recall

In December 2011, an advisory committee to the Food and Drug Administration (FDA) voted 15 to 11 that birth control pills Yaz and Yasmin® offered more benefits than risks. Now a group of women’s health organizations have expressed concerns over conflicts of interest that may have affected the panel’s vote.

The Jacobs Institute of Women’s Health, the National Research Center for Women and Families, the National Women’s Health Network, and Our Bodies Ourselves sent a letter to FDA Commissioner Dr. Margaret Hamburg to encourage the FDA to re-examine its policies and committee biases in future decisions regarding the birth control pills.

At least four panel members were previously affiliated with Yaz and Yasmin manufacturer Bayer Healthcare as consultants or researchers. Additionally, Ob/Gyn physician Sidney Wolfe was barred from voting because his consumer watchdog group Public Citizen has spoken out about Yaz and Yasmin and petitioned the FDA for a recall.

Panel members were also confused as to whether they were being asked to compare the safety of Yaz and Yasmin to other birth control pills or whether they were being asked to compare the risks of taking Yaz versus pregnancy.

Yaz and Yasmin contain progestin drospirenone, which may increase risk of blood clots by 75% over older birth control pills. The pills also double the risk of heart attacks and strokes in those who’ve never used birth control pills.

Over 10,000 women in the U.S. have filed a lawsuit against Bayer. The women suffered a stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT), gallbladder disease or other injuries as side effects of drospirenone. The lawsuits allege that Bayer failed to adequately warn about the risks associated with Yaz and Yasmin use.


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