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FDA Approves Anti-Clotting Drug for Stroke Prevention

EKG (Photos8.com)
(Photos8.com)

The U.S. Food and Drug Administration today approved the anti-clotting drug rivaroxaban to reduce the risk of stroke in people with abnormal heart rhythms from atrial fibrillation due to problems other than faulty heart valves. The drug is marketed under the name Xarelto in the U.S. by Janssen Pharmaceuticals in Raritan, New Jersey, a subsidiary of Johnson & Johnson.

According to the American College of Cardiology, atrial fibrillation (AF) affects 2.2 million people in the U.S., making it the most common form of heart rhythm problem, and the cause of 15 to 20 percent of strokes. With conditions such as AF, if the heart is not beating properly, blood can pool in the heart’s upper chambers or atria. This pooling of blood can lead to the formation of blood clots in the atria, which can cause a stroke if clots are carried through the blood stream to the arteries of the brain.

Rivaroxaban is a form of blood anti-coagulant that works by blocking a clotting factor known as Xa, and thus reduces the likelihood of blood forming clots. In July, FDA approved Xarelto to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism (blockage of lung arteries) following knee or hip replacement surgery.

The drug was tested in a phase 3 clinical trial involving more than 14,000 patients with non-valvular AF from 2006 to 2010. The randomized, double-blind trial tested rivaroxaban against a placebo and warfarin, a currently prescribed anti-coagulant. The trial showed that the once-daily rivaroxaban effectively reduced the risk of stroke and blood clots in patients with non-valvular atrial fibrillation, with major bleeding rates comparable to warfarin.

While the rate of bleeding for rivaroxaban was similar to warfarin, cases of bleeding from rivaroxaban were more likely to occur in the stomach and intestines rather than the brain. FDA has required production of a medication guide for patients and caregivers when Xarelto is dispensed, describing the risks and adverse reactions people when using the drug.

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