The Food and Drug Administration (FDA) on Nov. 4 approved rivaroxaban (XARELTO®) for the prevention of stroke in nonvalvular atrial fibrillation. Rivaroxaban is an oral anticoagulant that acts by selective direct inhibition of factor Xa (FXa).
According to the FDA, rivaroxaban should be taken one time a day with the evening meal so that it will be completely absorbed. An FDA-required Medication Guide, which will be 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 this past September in a vote of 9-2, with one abstention. Rivaroxaban, which is already on the market for the prevention of deep vein thrombosis in knee or hip replacement surgery, 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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