The Medical Letter on Drugs and Therapeutics
Bleeding with Dabigatran (Pradaxa)
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The labeling of dabigatran etexilate (Pradaxa – Boehringer Ingelheim), an oral direct thrombin inhibitor, has recently been updated to include new dosing and monitoring recommendations and a warning on the risk of bleeding. Dabigatran etexilate was approved in the US in 2010 for the prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation. It has been shown to be more effective than warfarin (Coumadin, and others) for this indication.1

NEW RECOMMENDATIONS — Dosing – Renal impairment increases dabigatran serum concentrations and the risk of bleeding.2 The revised label recommends that renal function be assessed before starting dabigatran and, in patients >75 years old or in those with a CrCl <50 mL/min, at least annually during treatment. The dosage of dabigatran should be adjusted with ... more      

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Title: Bleeding with Dabigatran (Pradaxa)
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