Anticoagulant Dabigatran Bleeding Deaths Raise Safety Concern.

MedPage Today  (11/3, Kaiser) reports that according to an article in the German publication Die Zeit, "the anticoagulant dabigatran [Pradaxa] has been linked to about 50 deaths from bleeding in atrial fibrillation patients," which is raising concern "but the drug's manufacturer said the safety profile is where it should be." Boehringer Ingelheim said, "The clinical effectiveness and favorable safety profile of Pradaxa is positive and remains unchanged in light of recent reports about fatal cases of bleeding in the media." The company said "the bleeding events and fatal bleedings reported to date are considerably fewer than expected based on the trial data that support the use of Pradaxa in clinical practice," citing two studies (N Engl J Med 2009; 361: 1139-1151 and N Engl J Med 2010; 363(19): 1875-1876).