FDA is investigating whether postmarketing reports of serious bleeding events after taking Boehringer Ingelheim GMBH’s Pradaxa (dabigatran) reflect a higher incidence than was anticipated based on clinical trial results, the agency announced Dec. 7.
Pradaxa Bleeding Deaths Spur FDA Concerns, European Label Changes
FDA is investigating reports that more patients are experiencing serious bleeding events after taking Boehringer Ingelheim GmbH’s Pradaxa (dabigatran) than anticipated based on clinical trial results.