In 2011 the FDA received more safety reports about dabigatran than any other drug. The data notes that since the bleeding complications of dabigatran are well known and physicians are more likely to report adverse events associated with new drugs, there may be more safety reports.
Dabigatran was the subject of 3,781 serious adverse events reported to the FDA in 2011. This included 542 patient deaths and 2,367 hemorrhages. Warfarin was the subject of 1,106 serious adverse events, including 72 deaths.
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