The Hospice Clinician Blog

The FDA announced today that it is now investigating post-marketing reports of serious bleeding events in patients taking dabigatran (Pradaxa®). Dabigatran is a direct and reversible thrombin inhibitor, used as an alternative to warfarin in patients requiring anticoagulation. Dabigatran is FDA-approved for prevention of thromboembolism and/or stroke at a dose of 150 mg twice daily.

Dabigatran is an attractive therapy for a number of reasons. In the large clinical trial (the RE-LY trial) that led to dabigatran’s approval, dabigatran was more effective than warfarin at preventing both ischemic and hemorrhagic stroke (35% risk reduction). Dabigatran dosing is simple and INR monitoring is not required, as it is with warfarin. Dabigatran has far fewer drug-drug and drug-food interactions than warfarin.

In the RE-LY trial, rates of bleeding with dabigatran were similar to warfarin, so it is expected that some patients taking dabigatran would experience bleeding. What the FDA is investigating is whether the number of post-marketing reports of bleeding it is receiving makes sense based on the rates of bleeding found in the RE-LY trial.

The FDA said it will inform the public and clinicians about any new information about bleeding risks when it becomes available. In the meantime, the agency said it believes dabigatran provides an important health benefit when used as directed and that patients taking dabigatran should not stop taking the drug without talking to their doctor.

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