FDA approves J&J's Xarelto for stroke prevention

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for preventing stroke in patients with abnormal heart rhythm, the agency said.

The agency announced Friday the approval of Xarelto (rivaroxaban), an anti-clotting made by J&J subsidiary Janssen Pharmaceuticals, in patients with non-valvular atrial fibrillation. The FDA approved the drug in the 10-mg strength in July for deep-vein thrombosis in patients receiving knee and hip replacement surgery. The latest approval includes 15-mg and 20-mg strengths.

Atrial fibrillation is one of the most common types of abnormal heart rhythm and affects more than 2 million people. The condition causes irregular and poorly coordinated beating of the heart's two upper chambers, which leads to pooling and clotting of blood.

"Atrial fibrillation can lead to the formation of blood clots, which can travel to the brain, blocking blood flow and causing a disabling stroke," FDA Division of Cardiovascular and Renal Products director Normal Stockbridge said. "This approval gives doctors and patients another treatment option for a condition that must be managed carefully."


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