November 2nd, 2012
FDA Investigation Finds No Excess Bleeding Risk for Dabigatran
Larry Husten, PHD
In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the full FDA statement. Here is the first paragraph of the statement:
The U.S. Food and Drug Administration (FDA) has evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics). Following the approval of Pradaxa, FDA received a large number of post-marketing reports of bleeding among Pradaxa users. As a result, FDA investigated the actual rates of gastrointestinal bleeding (occurring in the stomach and intestines) and intracranial hemorrhage (a type of bleeding in the brain) for new users of Pradaxa compared to new users of warfarin. This assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The results of this Mini-Sentinel assessment 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, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).1 (see Data Summary). FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.
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