Johnson & Johnson and Bayer’s new pill to prevent blood clots after hip or knee surgery may cause excess bleeding in “significantly more patients” than the standard drug, Sanofi-Aventis’ Lovenox, U.S. regulators said.
Risks for liver injury and other damage were less clear in studies of the experimental drug, rivaroxaban, which Bayer and J&J plan to market as Xarelto, according to a review by Food and Drug Administration staff posted today on the agency’s Web site. A panel of FDA advisers will consider the findings when they meet March 19 to recommend whether the tablets can be sold in the U.S.
Xarelto would be the U.S.’s first new oral anticoagulant, used to prevent blood clots in the veins, since warfarin was approved in 1954.
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