Bleeding concerns with dabigatran

Bleeding concerns with dabigatran

Dabigatran (Pradaxa), Boehringer Ingelheim's blockbuster anticoagulant, is the subject of a December 7, 2011, Drug Safety Communication by the FDA regarding serious bleeding events. The FDA is evaluating postmarketing reports of serious bleeding events that may lead to serious or even fatal outcomes. Experts are working to determine whether the reports of bleeding associated with the drug are occurring more commonly than would be expected based on observations from large clinical trials. The drug was approved in October 2010 to reduce the risk of stroke in patients with non-valvular atrial fibrillation. More than a million prescriptions have been filled by nearly 400,000 patients since approval.