An Update on Yaz and Yasmin Litigation | Ohio Personal Injury Attorney
On December 8, 2011, The FDA Reproductive Health Drugs Advisory Committee overwhelmingly concluded that Bay should warn users of the 4th generation, drosperinone-containing oral birth control pills, Yaz and Yasmin are at a higher risk for blood clots that users of 2nd generation birth control pills.
Regulatory officials in Europe had also required Bayer to change its warning label to accurately reflect the increased risk of blood clots with Yas and Yasmin usage.
Unsealed court documents indicate that Bayer withheld safety data from the FDA during the approval process for Yasmin. David Kessler, former FDA Commissioner, stated in his report filed in the Yaz/Yasmin Multidistrict Litigationthat Bayer withheld adverse information from the FDA in order to gain marketing approval for Yasmin in 2001.
During the committee meeting, the advisory panel heard presentations from the FDA and various independent studies that also show that drosperinone-containing oral birth control pills double the risk of blood clots in comparison with 2nd generation pills. Bayer presented data to the panel to defend its drosperinone-brand. Bayer-funded studies are the only studies that show no increase in risk in Yaz or Yasmin users.
Over 10,000 cases have been filed against Bayer.
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