December 7th, 2011
FDA Undertakes Safety Review of Dabigatran (Pradaxa)
The FDA announced today that it is initiating a safety review of dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug.
Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The agency says it is “working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected.”
The FDA notes that it is difficult to compare bleeding complications between dabigatran and warfarin, since complications associated with the older warfarin may be less likely to provoke an adverse event report.