Bayer AG Concealed Yasmin's Clot Risk, Former FDA Chief Says

Published: Dec 07, 2011

A Bayer AG unit withheld from U.S. regulators findings by company researchers of increased reports of blood clots in users of its Yasmin birth-control pills, the former head of the Food and Drug Administration said. David Kessler, the former FDA commissioner, in a document unsealed yesterday in federal court in Illinois, said Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin’s safety provided to the agency.

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