SAFETY ALERT: FDA Evaluating Risk of Serious Bleeding Events with Pradaxa

The FDA has notified healthcare professionals that it is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim). 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. Patients with atrial fibrillation should not stop taking Pradaxa without talking to their healthcare provider.

In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs. However, at present the FDA is evaluating the post-marketing reports of serious bleeding in patients taking Pradaxa submitted to the Adverse Events Reporting System database. While serious, even fatal events have been reported, the FDA is analyzing the events 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.

Pradaxa is a direct thrombin inhibitor indicated for the reduction in risk of stroke and systemic embolism in non-valvular atrial fibrillation.

For more information, visit www.fda.gov/Drugs/DrugSafety/ucm282724.htm.