The FDA is evaluating post-marketing reports of serious bleeding events in patients taking dabigatran (Pradaxa), to determine whether these reports are occurring more commonly than would be expected, based on observations in the large clinical trial of 18,000 patients with non-valvular atrial fibrillation that supported the approval of dabigatran. This study noted that major bleeding events occurred at similar rates to warfarin. The drug label for dabigatran does contain a warning about significant and sometimes fatal bleeds.

The Agency states that at this time, it continues to believe that dabigatran provides an important health benefit when used as directed and recommends that healthcare professionals follow the recommendations in the approved drug label. It will communicate any new information on the risk of bleeding with dabigatran when it becomes available.