FDA Approves New Anticoagulant Use

The anticoagulant Rivaroxaban (Xarelto), already approved to reduce the risk of DVT (deep vein thrombosis) and pulmonary embolism (PE) after knee or hip replacement surgery, has received FDA approval to treat DVT and PE and to reduce the risk of a recurrence after initial treatment, according to Thomas R. Collins, writing in The Hospitalist.

“Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin nearly 60 years ago, ” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a news release.

Collins quoted Hiren Shah, M.D., and assistant professor of medicine at Northwestern University’s Feinberg School of Medicine and medical director of hospital medicine at Northwestern Memorial Hospital in Chicago, as saying that the approval is a major breakthrough. He said that patients no longer will need parenteral bridging with low-molecular-weight heparin or transition to a vitamin-K antagonist. Rivaroxaban will be all they need and it will eliminate the need for drug-level monitoring that comes with warfarin.

“Single-drug therapy without the need for parental bridging treatment, or drug-level monitoring, is a breakthrough in the treatment of VTE [venous thromboembolism], and represents a paradigm shift that we have not seen in a long time for a very common emergency room and hospital-based medical condition, ” Shah added.