Bayer Covered Up Yasmin Blood Clot Risk: Ex-FDA Head
By Sindhu Sundar (December 5, 2011, 10:54 PM EST) -- Bayer AG hid the significance of potentially serious side effects of its Yasmin contraceptives despite knowing they were more likely to cause blood clots than other oral contraceptives, according to a former U.S. Food and Drug Administration chief's report unsealed Monday in multidistrict litigation in Illinois.
In a 121-page expert report, former FDA Commissioner David Kessler said the drugmaker had documented in the draft of an August 2004 white paper that Yasmin was 10 times more likely to cause serious side effects including deep vein thrombosis, the formation of a clot in a deep vein.
But in the white paper it...
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