New Evidence Raises Concerns About Safety of Pradaxa in Patients with Mechanical Heart Valves

Posted by The Evidence Blog on February 14, 2013

Based on evidence from the European RE-ALIGN trial, the Food and Drug Administration (FDA) has informed healthcare professionals and the public that the anticoagulant dabigatran (Pradaxa) should not be used to prevent stroke or blood clots in patients with mechanical prosthetic heart valves. Investigators stopped the RE-ALIGN trial because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than patients who took the anticoagulant warfarin. There was also more bleeding after valve surgery in patients who used Pradaxa compared with those who used warfarin.

Read more about the recent concerns about Pradaxa drug safety in the Hayes News Service.

Topics: Hayes Blog

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