NorthPoint Domain

FDA Announces Safety Review of Pradaxa

By Robert Fay

The U.S. Food and Drug Administration (FDA) has announced it will undertake a safety review of the anticoagulant dabigatran (Pradaxa) to evaluate post-marketing reports of serious bleeding events. The drug, an oral direct thrombin inhibitor, was approved in October 2010 for the prevention of stroke in patients with nonvalvular atrial fibrillation.

The agency stated that it would evaluate reports submitted to the Adverse Events Reporting System database to determine if there are more than expected, based on the results of the RE-LY trial. RE-LY, which formed the basis for the drug's approval and included more than 18,000 patients, compared two doses of dabigatran and warfarin, finding that major bleeding events occurred at similar rates.

The FDA wrote that it "believes the benefits of Pradaxa continue to exceed the potential risks when the drug is used appropriately following the approved drug label. FDA recommends that healthcare professionals continue to prescribe Pradaxa following the recommendations in the drug label."

Source: U.S. Food and Drug Administration. 2011. FDA drug safety communication: safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran extexilate mesylate). Published on December 7, 2011 on the FDA website.