Ex-FDA Commissioner Slams Xarelto Warnings In Philly Trial

Law360, Philadelphia (November 14, 2017, 7:36 PM EST) -- A former Food and Drug Administration commissioner told a Philadelphia jury on Tuesday that warning labels for the blood thinner Xarelto failed to provide adequate information to doctors and consumers about the risk of bleeding that some patients could face when using the drug.

David Kessler, who headed the FDA under both President George H.W. Bush and President Bill Clinton, told jurors that Bayer AG and Johnson & Johnson's warning labels for the medication understated the risk of significant bleeding events that had been seen in clinical trials involving patients in the United States.

"They did not adequately notify physicians that...

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