The FDA Reproductive Health Drugs Advisory Committee, on December 8, 2011, overwhelmingly concluded that Bayer should warn that users of its 4th generation, drosperinone-containing oral birth control pills, Yaz and Yasmin, are at an increased risk of blood clots than users of 2nd generation birth control pills. Regulatory officials in Europe had previously required Bayer to change its warning label to accurately reflect the increased risk of blood clots with Yaz and Yasmin usage.
Court documents unsealed last month indicate that Bayer withheld safety data from the FDA during the market approval process of Yasmin. While that should shock most folks, none of our lawyers were even surprised over that revelation. David Kessler, former FDA Commissioner, concluded in his expert report filed in the Yaz/Yasmin Multidistrict Litigation (MDL) that Bayer withheld vital adverse event information from the FDA in order to obtain marketing approval for Yasmin in 2001. Bayer agreed to remove the confidentiality designation on the report last month, but after the deadline for submitting written materials for panel consideration.
During the committee meeting, the advisory panel heard presentations from the FDA which included data obtained from a Kaiser Permanente study sponsored by the FDA. This study found that users of Yasmin were at an increased risk of blood clots compared to users of 2nd generation birth control pills. The agency also presented information from numerous, independent medical studies which have likewise concluded that drosperinone-containing oral birth control pills double the risk of blood clots in comparison with 2nd generation pills. Kessler, the former FDA Commissioner, had this to say about the concealment:
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.
Bayer presented data to the panel defending its drosperinone-brand. Only Bayer-funded studies have found no increase in risk in Yaz or Yasmin users. Meanwhile, over 10,000 lawsuits have been filed against Bayer, and the bellwether trial process is in full swing. The first MDL bellwether trial involving a pulmonary embolism injury will start on January 9, 2012, while the first Pennsylvania bellwether trial involving a pulmonary embolism injury will start on January 23, 2012.
If you want more information on this subject, contact or Roger Smith at 800-898-2034 or by email at Roger.Smith@beasleyallen.com.
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