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First new oral medication to treat Deep Vein Thrombosis in 60 years approved by FDA

The Food and Drug Adminstration has announced approval of Rivaroxaban (Xarelto), the first oral medication approved for the treatment of DVT since the approval of Warfarin (Coumadin) 60 years ago.

Rivaroxaban’s approval was based mainly on results from three trials with a total of 9,478 patients randomized to Rivaroxaban, placebo, and Enoxaparin (Lovenox) combined with a vitamin K antagonist such as Warfarin (Coumadin).

A simple oral regimen of fixed-dose Xarelto treated Deep Vein Thrombosis (DVT) and recurrence of pulmonary embolism as well as a sequence of low-molecular-weight heparin and warfarin does, but with less bleeding risk, clinical trial determined. A placebo-controlled trial showed that 1.3% of patients taking rivaroxaban had recurrent thromboembolic events compared with 7.1% of those assigned to placebo.

The major adverse event with Xarelto is increased risk of bleeding, as is the case with other anticoagulant drugs. The studies also indicated that Rivaroxaban has a lower risk of bleeding events. For example, in the EINSTEIN-PE trial, reported earlier this year in the New England Journal of Medicine and at the American College of Cardiology’s annual meeting, 1.1% of patients on Rivaroxaban had major bleeding versus 2.2% with Enoxaparin. However the bleeding events when they occur may be harder to treat because there is no ready antidote to reverse the blood thinning effect of Xarelto if bleeding occurs.

Another major advantage of Rivaroxaban, an oral Factor Xa inhibitor, is that it doesn’t require the close monitoring of coagulation activity needed with Heparin and its analogs. “All in all, this is a welcomed option for patients who develop or need to prevent a DVT or a pulmonary embolism,” says Dr. Thomas Wright, the medical director of Laser Lipo and Vein Center in O’Fallon, MO.

Deep vein thrombosis is the formation of a blood clot in the deep veins. When a thrombosis detaches and subsequently travels to the lungs, it is called a pulmonary embolism. The conditions affect about 1 in 1,000 adults annually.

Dr. Wright is the Medical Director of the Laser Lipo and Vein Center in St Louis, Missouri. His practice specializes in vein treatment and cosmetic medicine, including treatment and diagnosis of vein disease. Dr. Wright was one of the first two-hundred-plus surgeons in the United States to become board certified in Phlebology by the American Board of Phlebology. Dr. Wright received his undergraduate degree from Duke University in Durham, NC and completed his medical training at the University of Missouri at Columbia. He completed his residency at the University of Alabama Birmingham. He is a Fellow of the American Society of Laser Medicine and Surgery, and a former Howard Hughes Research Fellow.

To contact Dr. Wright, please call (636) 397-4012