Bleeding rates with dabigatran are not higher than bleeding rates with warfarin, FDA assessment finds

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A new FDA assessment on the risk of serious bleeding associated with use of the anticoagulants dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics) has indicated that bleeding rates associated with new use of dabigatran do not appear to be higher than bleeding rates associated with new use of warfarin.

This assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The assessment is consistent with observations from the large RE-LY clinical trial used to approve Pradaxa for the prevention of stroke in patients with non-valvular atrial fibrillation. The FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.

The FDA has communicated that it has not changed its recommendations regarding dabigatran. “Pradaxa provides an important health benefit when used as directed,” stated the FDA. The FDA also recommends healthcare professionals who prescribe this anticoagulant should carefully follow the dosing recommendations in the drug label, especially for patients with renal impairment to reduce the risk of bleeding.


“Patients with atrial fibrillation should not stop taking Pradaxa without first talking to their healthcare professional,” said FDA. “Stopping use of anticoagulant medications such as Pradaxa can increase the risk of stroke.”


To report any serious adverse events and product quality problems contact FDA’s MedWatch.

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