The National Blood Clot Alliance (NBCA) welcomes the November 4, 2011, FDA approval of the new oral anticoagulant, rivaroxaban (Brand: Xarelto®; Janssen Pharmaceuticals), for the prevention of stroke in patients with atrial fibrillation (AFib), the most common cardiac rhythm disturbance. In clinical trials, rivaroxaban was shown to prevent stroke as well as Coumadin™, the traditional oral anticoagulant used by millions of individuals with blood clotting disorders. In comparison to Coumadin™, there were a similar number of major bleeding complications, which is the major side effect of an anticoagulant, but there were significantly fewer bleeding episodes affecting the brain, which is the most feared complication.
Jack Ansell, MD, Chief of Medicine at Lenox Hill Hospital (NY) and Chair of NBCA’s Medical and Scientific Advisory Board said “this represents an important option for patients with AFib because warfarin is often difficult for patients and doctors to manage.”
Rivaroxaban is the second new oral anticoagulant to be approved in the last two years. The first was dabigatran etexilate (Pradaxa™; Boehringer Ingelheim Pharmaceuticals), which is now used by many individuals with AFib. These new drugs have advantages over Coumadin™ in that they do not require routine monitoring of the drug level and their effect is not influenced by diet or many other drugs. As a result, they are less burdensome for the patient to manage as well as for the doctor.
NBCA CEO, Alan Brownstein said “these advantages are important to the 2.6 million people in the US with AFib (a number that will grow to 12 million by the year 2050).”
Ansell added “that while these advances are much needed, we also need other blood thinner options for patients at risk for blood clots in the leg (Deep Vein Thrombosis-DVT) and the lung (Pulmonary Embolism- PE).”
At the present time, there are a number of other new oral anticoagulants under study with the expectation that additional drugs will be on the market in the next few years.
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