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FDA Plans New Safety Assessment of Dabigatran — Physician’s First Watch

Medical News |
January 6, 2014

FDA Plans New Safety Assessment of Dabigatran

By Larry Husten

The FDA plans to perform a large new assessment of dabigatran (Pradaxa) compared with warfarin. Since dabigatran's approval in Europe in 2008 and in the U.S. in 2010, there have been persistent concerns about the drug's safety.

On December 30, 2013, the FDA posted a request for public comment on a proposed protocol of the study, which it describes as "a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin." The study will "assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation using data from the FDA Mini-Sentinel Distributed Database."

At this point, there is no plan to assess the safety of the new oral anticoagulants that received approval after dabigatran — rivaroxaban (Xarelto) and apixaban (Eliquis).

Editor's note: Adapted with permission from CardioExchange.

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