- Pradaxa (dabigatran) was approved by the FDA in 2010 and the EMA in 2011 for stroke prevention in individuals with atrial fibrillation (AF).
- Pradaxa is one of the new oral anticoagulants (NOACs) that have been marketed as preferable alternatives to warfarin, ostensibly because of its ease of use, lower monitoring requirements and fewer incidences of major bleeding.
- There has been pushback against the use of NOACs due to safety concerns around the inability to reverse major bleeding episodes. The latest concerns are being publicized by British Medical Journal (BMJ) investigators.
In mid-June, Biopharma Dive reported on lawsuits against manufacturers of NOACs. Boehringer Ingelheim has faced an onslaught of litigation, eventually reaching a $650 million settlement in May with patients who suffered harm as a result of treatment with Pradaxa.
Investigators are taking a closer look at data from the phase III RG-LY trial, specifically focusing on the calculations showing that using Dabigatran can reduce major bleeds by 30% to 40% compared to warfarin. Regulators have questioned Boehringer about the need for monitoring drug levels in the blood; approvals in both the US and Europe did not require such monitoring.
Boehringer is fighting back and has asserted that the BMJ investigators do not have a "full understanding" of the challenges associated with treating AF. Look for continued scrutiny of NOACs as clinicians increase their use of this class of anticoagulants.