According to a report, the ex-head of the FDA, David Kessler, claims that despite having documented evidence that serious side effects like blood clots and deep vein thrombosis (DVT) were 10 times more likely, Bayer chose to hide the findings.
Kessler claims that the documentation originally appeared in an early draft of an August 2004 white paper; however, when the paper was submitted to the FDA the statement mentioning the increased risk of DVT was omitted.
Kessler’s comments came in a 121-page expert report released by attorneys representing former users of Yasmin and other similar birth control medications that have filed lawsuits against the company alleging injuries. Many of these alleged injuries involve blood clots and DVT.
According to a Bloomberg report, the paper was submitted to the FDA after the agency expressed concerns over a large number of adverse events associated with Yasmin, in a June 2003 letter.
Last week an FDA advisory panel reviewing data about risks voted to keep Yasmin and Yaz on the market, but called for clearer and more informative risk information as well as the addition of blood clot risks to the drugs’ labels.
Bayer is current facing more 10,000 lawsuits over injuries allegedly caused by the drugs. The first trials are scheduled for next month both in Federal Court in Illinois and state court in Philadelphia.
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