November 02, 2012
Evaluation of Bleeding Risk Associated with Pradaxa and Warfarin
The FDA evaluated new information about the risk of serious bleeding associated with use of dabigatran (Pradaxa; Boehringer Ingelheim) and warfarin (Coumadin, Jantoven, and generics).
This assessment was done using insurance claims and administrative data from FDA's Mini-Sentinel pilot of the Sentinel Initiative. The results indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin. This is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).
The FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue, and has not changed its recommendations regarding Pradaxa.
Healthcare professionals who prescribe Pradaxa 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.
For more information visit http://www.fda.gov/