The U.S. Food and Drug Administration (FDA) is reviewing reports that hundreds of patients taking Pradaxa (dabigatran etexilate mesylate) have suffered from serious bleeding events. Some of the patients have reportedly died from the bleeding events and suffered other serious injuries. Pradaxa is a blood thining medication that is designed to reduce the risk of stroke in suffering from a common type of heart rhythm abnormality known as non-valvular atrial fibrillation (AF).
The Pradaxa study is designed to determine whether the numerous reports of bleeding in patients taking Pradaxa is taking place at a greater rate than would be expected in similar blood thining drugs. The FDA has reported that it is working closely with the maker of Pradaxa, Boehringer Ingelheim, and that it will publish any new information about the increased risk of bleeding in Pradaxa patients.