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FDA Approves Rivaroxaban to Reduce Risk of Stroke in AFib

The U.S. Food and Drug Administration (FDA) on Nov. 2 expanded the approved indications for rivaroxaban (XARELTO®). The drug is now approved for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as to reduce the risk of recurrent DVT and PE. The drug was previously approved for the prevention of thromboembolism and stroke in patients with nonvalvular atrial fibrillation and to reduce the risk of DVTs and PEs in patients undergoing knee or hip replacement surgery. “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, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

According to the FDA, rivaroxaban, an oral anticoagulant that acts by selective direct inhibition of factor Xa (FXa), should be taken once a day with the evening meal so that it will be completely absorbed. An FDA-required Medication Guide, which is given to patients and caregivers when rivaroxaban is dispensed, describes the risks and adverse reactions people should be mindful of when using the drug. In addition, a boxed warning also makes it clear that people using the drug should not discontinue it before talking with their health care professional. Discontinuing the drug can increase the risk of stroke.

The FDA's Cardiovascular and Renal Drugs Advisory Committee recommended approval of the drug in in 2011 in a vote of 9-2, with one abstention. Rivaroxaban, was tested and found noninferior vs. warfarin among high-risk patients with atrial fibrillation in the ROCKET AF trial in 2010. Future ACCF/AHA guidelines will address the use of rivaroxaban and similar drugs for the treatment of atrial fibrillation.

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