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FDA cites bleeding risk with experimental J&J drug

March 17, 2009
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The Associated Press reports that federal health officials say a Johnson & Johnson drug helps prevent deadly blood clots in patients getting hip or knee replacement surgery, but it also carries serious risks of internal bleeding. Johnson & Johnson and partner Bayer have asked the Food and Drug Administration to approve their once-daily pill rivaroxaban as an anti-clotting drug to stop blood clots in legs. More than 800,000 U.S. patients receive hip or knee replacements each year with blood clots being a frequent side effect. But FDA regulators say the drug carries nearly twice the risk of bleeding than Sanofi-Aventis'' Lovenox, the top-selling blood thinner used by patients receiving orthopedic implants. The FDA will seek the opinion of a panel of experts at a later date.
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