European Medicines Agency puts Pradaxa deaths in to perspective
This article was originally published in Scrip
Executive Summary
The European Medicines Agency is updating the safety information for Boehringer Ingelheim's warfarin-replacement anticoagulant Pradaxa (dabigatran) following reports that 256 patients taking the drug had died due to serious bleeding. However, the agency is not unduly concerned. It points out that the deaths have occurred following increased uptake thanks to the approval of the new stroke prevention indication.