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Bayer Withheld YAZ/Yasmin Blot Clot Data from FDA

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Chicago, ILCourt documents unsealed earlier this week reveal that Bayer, the maker of the oral contraceptives YAZ/Yasmin, allegedly failed to submit all safety data, specifically data regarding blood clots, to the Food and Drug Administration (FDA) prior to agency approval of the drugs. The former head of the FDA, David Kessler, noted in the report that in a 2004 safety review of YAZ/Yasmin, an analysis "that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or blood clots, was also not provided to the agency.

According to a report by Bloomberg "Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin," Kessler said in the unsealed document (as quoted by Bloomberg). Kessler also states that Bayer withheld data prior to the 2001 FDA approval of Yasmin, including details about clot risks from an internal study and two cases of clots in women using the pill. "Had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin's NDA could be made," he stated. (Bloomberg).

Ironically, the FDA Reproductive Health Drugs Advisory Committee is to meet shortly to assess the risks and benefits of the newer birth control pills containing drospirenone, such as YAZ/Yasmin, Ocella, Beyaz and Safyral.

Bayer currently faces over 10,000 lawsuits alleging injuries caused by its contraceptives. Lawyers representing the plaintiffs are citing FDA reports of at least 50 deaths related to the use of YAZ/Yasmin between 2004 and 2008.

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