Wednesday, March 14, 2012

FDA cites bleeding risk with experimental J&J drug

Federal health officials say a Johnson & Johnson drug helps prevent deadly blood clots in patients getting hip or knee replacement, but it also carries a risk of serious internal bleeding.

Johnson & Johnson and partner Bayer have asked the Food and Drug Administration to approve their once-daily pill, rivaroxaban, as an anticlotting drug to stop blood clots in legs and those that can travel to the lungs. More than 800,000 U.S. patients receive hip or knee replacements each year, and an estimated 40 to 60 percent are at risk of blood clots.

But FDA regulators said in documents posted online Tuesday that the drug carries nearly twice the risk of …

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