Pradaxa regulatory update

FDA said it is reviewing postmarketing reports of serious bleeding events in patients receiving atrial fibrillation (AF) drug Pradaxa dabigatran etexilate from Boehringer. The agency said it believes that the direct oral thrombin inhibitor provides an important additional benefit when used as directed and that healthcare officials who prescribe Pradaxa follow the recommendations in the approved label. The product is approved in the U.S. and EU to prevent stroke and blood clots in patients with AF and in the EU to prevent venous thromboembolic (VTE) events in adults who have undergone elective total hip or knee replacement surgery and to prevent systemic embolism in patients with non-valvular AF. ...