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Federal Court Unseals Document Claiming Bayer Withheld Yasmin Data from FDA

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In a document recently unsealed in federal court, David Kessler, the former US Food and Drug Administration  (FDA) commissioner said Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or blood clots, in a 2004 review of the oral contraceptive Yasmin, provided to the FDA, Bloomberg reported.

Kessler also said that the report didn’t include an earlier draft opinion by Bayer researchers that “spontaneous reporting data do signal a difference in the VTE rate for Yasmin” when compared with other oral contraceptives. “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Kessler said.

Bayer is currently facing more than 10,000 lawsuits over injuries caused by the oral contraceptives Yasmin and Yaz. Lawyers involved in the lawsuits have cited FDA reports of more than 50 deaths allegedly caused by the medications from 2004 to 2008.

In October, the FDA issued a warning that women taking birth control containing drospirenone were 74 percent more likely to suffer blood clots than women on other low-estrogen birth control. The FDA is scheduled to discuss the findings of an analysis of 835,826 women who used drospirenone, during a December 8 hearing.

The first trials for the lawsuits are set to begin next month in Illinois federal court, and Pennsylvania state court. Most of the suits allege that Bayer didn’t sufficiently warn patients of the health risks of the contraceptives. They also complain that Bayer marketed the drugs for unapproved uses. disclaimer: This article: Federal Court Unseals Document Claiming Bayer Withheld Yasmin Data from FDA was posted on Tuesday, December 6th, 2011 at 8:59 pm at and is filed under Defective Drug Lawsuits.

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