Physicians or others who want to weigh in on a draft protocol to assess safety outcomes in atrial fibrillation patients newly treated with dabigatran or warfarin have until Jan. 13 to submit comments.
The Mini-Sentinel Operations Center made a final draft protocol available online for public comment. The protocol is designed to provide a one-time assessment of rates of bleeding and thromboembolic outcomes with the two anticoagulants.
A workgroup led by Alan S. Go, MD, of Kaiser Permanente Northern California in Oakland; Joshua Gagne, PharmD, ScD, of Brigham and Women's Hospital in Boston; and Marsha Reichman, PhD, and David Graham, MD, MPH, of the FDA, will review comments. Revisions, if they occur, will be noted and included in an amended protocol.
Dabigatran (Pradaxa, Boehringer Ingelheim) is an oral direct thrombin inhibitor that was approved by the FDA in 2010 to reduce the risk of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The FDA sponsors the Mini-Sentinel as part of surveillance efforts to monitor the safety of regulated products.