FDA Updates on Bleeding Risk of Pradaxa

The FDA’s recommendations regarding Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) remain unchanged following the November 2012 Mini-Sentinel evaluations. Pradaxa is an anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

These evaluations compared the risk of serious gastrointestinal bleeding and a type of intracranial hemorrhage associated with new users of Pradaxa and warfarin. The agency sought to determine whether the large number of bleeding reports reflected a true increased bleeding risk relative to warfarin in the post-marketing setting. This assessment was done using insurance claims and administrative data from the FDA’s Mini-Sentinel pilot of the Sentinel Initiative for the period from October 19, 2010–December 31, 2011. Findings showed that bleeding rates associated with Pradaxa use during the period did not appear to be higher than those associated with warfarin.

The findings from the Mini-Sentinel pilot remain consistent with the results of the RE-LY trial, which showed that warfarin and Pradaxa exhibited a similar risk of bleeding in patients with nonvalvular atrial fibrillation. Initially, the high post-marketing rates of bleeding with Pradaxa had led to many discussions regarding its benefit-risk profile. In December 2011, the FDA released a safety alert to convey the information on bleeding to health care practitioners and patients. However, the Mini-Sentinel assessment serves to reaffirm the data from RE-LY in respect to comparative bleeding rates.

This FDA perspective was published online on March 13, 2013 in the New England Journal of Medicine.

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