The FDA is evaluating post-marketing reports of serious bleeding events in patients that are taking Pradaxa (dabigatran etexilate mesylate). Pradaxa, a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), contains a drug label that warns about significant and sometimes fatal bleeds, bleeding that may lead to serious or even fatal outcomes.
In a large clinical trial involving 18,000 patients, Pradaxa and warfarin were compared, with major bleeding events occurring at similar rates with the two drugs.
The FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.
At this time, the FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label. Are there right about this? Who knows? Clearly, patients with AF should not stop taking Pradaxa. Should they be talking to their doctor about these new concerns? Of course.
The FDA says it will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.