Drug Industry Daily reported on December 7th that David Kessler, a former FDA commissioner alleged that Bayer purposely hid safety information about Yaz from the FDA. More specifically, Kessler alleges that Bayer:
Declared in 2003 in advance of its analysis there was no increased risk of VTEs;
Failed to disclose that its own analysis revealed in 2004 an increased rate of VTEs compared to other oral contraceptives;
Presented selective views that obscured risks posed by Yasmin and Yaz; and
Failed to disclose data showing higher incidence of VTE with drospirenone compared to levonorgestrel.
Those are serious allegations. If true, they could support an award of punitive damages against Bayer in the thousands of Yaz lawsuits currently pending. Kessler also argues that the information purportedly hidden by Bayer could have delayed or derailed the approval of Yaz:
“Kessler wrote that if he knew of the adverse events prior to Yasmin's approval "I would have sought to investigate what was known or knowable about the incidence of serious adverse events, and would not have moved forward on a decision on NDA approval until such time as the results of the investigation were completed."
Yaz and Yasmin were both approved by the FDA in 2006. Since then, thousands of women have developed DVT’s or had pulmonary embolisms while taking the drug.
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