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  • FDA Date: 12/07/2011

    Pradaxa (dabigatran etexilate mesylate) FDA Drug Safety Communication

    Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is evaluating postmarketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Pradaxa is a blood-thinning (anticoagulant) medication used to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

    At this time, 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.

    Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood-thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.

    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. FDA is working closely with the manufacturer of Pradaxa (Boehringer Ingelheim) to evaluate the postmarket reports of bleeding.

    FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.

    View the full FDA Drug Safety Communication on FDA.gov