Bleeding risk of dabigatran under scrutiny

Serious bleeding events have been reported in patients taking dabigatran (Pradaxa), according to a new FDA MedWatch alert.
Labeling for the drug has not changed, and the FDA continues to believe that dabigatran provides an important health benefit when used as directed, but the agency will be investigating the drug's bleeding risk. The drug label currently contains a warning about significant and sometimes fatal bleeds, an FDA press release noted.
Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. In a large clinical trial (18,000 patients) comparing dabigatran and warfarin, major bleeding events occurred at similar rates with the two drugs. However, the FDA is working to determine whether the reports of bleeding are occurring more commonly than would be expected.
In the meantime, the agency recommends that clinicians who prescribe dabigatran follow the recommendations in the drug label and patients not stop the drug without talking to their health care professional.