The FDA has found that that bleeding rates associated with new use of dabigatran (Pradaxa, Boehringer Ingelheim) do not appear to be higher than bleeding rates associated with new use of warfarin, after evaluating new information about the anticoagulants.

This assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The agency pointed out that these findings are consistent with observations from the RE-LY clinical trial used to approve dabigatran. Also, the results of this assessment indicate FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.

As a result, the FDA has not changed its recommendations regarding dabigatran, which “provides an important health benefit when used as directed.” 

Similarly, in May, the European Medicines Agency recommended updating product information for the anticoagulant dabigatran to provide clearer guidance to doctors and patients on how to reduce and manage the risk of bleeding associated with the medicine in patients with atrial fibrillation. At the time, the committee concluded that the frequency of occurrence of fatal bleedings with dabigatran in post-marketing data was significantly lower than what was observed in the clinical trials used for approval of the drug and the benefits continue to outweigh its risks.

In its Nov. 2 notification, the FDA added that healthcare professionals who prescribe dabigatran 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 dabigatran without first talking to their healthcare professional, according to the agency, which added that stopping the use of anticoagulant medications such as dabigatran can increase the risk of stroke.