New Oral Anticoagulant Cleared for Reducing Stroke Risk

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Pradaxa (dabigatran etexilate) capsules have received FDA approval for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib). The medication, developed by Boehringer Ingelheim Pharmaceuticals of Ridgefield, Conn., is an oral direct thrombin inhibitor.

It is the first new oral anticoagulant approved in the United States in more than 50 years. As demonstrated in the 18,113-patient RE-LY trial, Pradaxa 150 mg taken twice daily significantly reduced stroke and systemic embolism by 35% beyond the reduction achieved with warfarin, the current standard of care for patients with non-valvular atrial fibrillation. Pradaxa 150 mg twice daily significantly reduced both ischemic and hemorrhagic strokes compared with warfarin.  

Treatment with Pradaxa does not require blood monitoring or related dose adjustments and has no recommended dietary restrictions. The FDA also approved Pradaxa 75 mg twice daily for the small subset of patients who have severe renal impairment.  

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