Taking the short-term view

FDA's Cardiovascular & Renal Drugs Advisory Committee last week set aside concerns about long-term off-label use, evidence of an increased incidence of bleeding and uncertainty about possible liver toxicity, and recommended approval of Xarelto rivaroxaban from Johnson & Johnson and Bayer AG for prophylaxis of venous thromboembolism in patients undergoing hip or knee replacement.

If approved, Xarelto would be the first new oral anti-coagulant available in the U.S. since warfarin was approved in 1954. Panel members predicted Xarelto's comparative ease of use would likely drive widespread off-label use, including for periods longer than the 35 days studied in clinical trials...