Compliance Management

FDA Approves Boehringer's Pradaxa Reversal Drug

Source: FDA.gov

Oct 20, 2015

The U.S. FDA granted accelerated approval to Boehringer Ingelheim's Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

The FDA approved Pradaxa in 2010 as an alternative to competitor warfarin to prevent blood clots and strokes in patients with atrial fibrillation. However, there was no antidote for Pradaxa -- meaning doctors could not immediately re-thicken a patient’s blood in the case of uncontrollable hemorrhage. The thinning effects of warfarin can quickly be reversed with vitmain k shots.

Praxbind solution is an intravenous injection that works by binding to the Pradaxa compound to neutralize its effect.

Read the FDA press release