Dabigatran Recommendation

On September 20, an FDA advisory panel unanimously recommended approval for Dabigatran (Pradaxa, Boehringer-Ingelheim) prophylaxis to prevent stroke in atrial fibrillation, as reported by Heartwire’s Steve Stiles. Dabigatran, an oral direct thrombin inhibitor, joins Rivaroxaban (Xarelto, Johnson & Johnson) an oral direct factor Xa inhibitor, as one of two new FDA panel-recommended oral antithrombotics that threaten to push warfarin off its 60-year perch as our only oral anticoagulant. Both have been cleared and are in use in Canada and the European Union, and both await final FDA clearance in the USA. Neither is affected by diet, neither appear to have toxic liver effects, and neither appear to require laboratory-based dosage monitoring.