October 16, 2015 — The FDA has approved Praxbind, the first reversal agent for the blood-thinner Pradaxa (dabigatran).
Praxbind is an intravenous drug that works by binding to Pradaxa to neutralize its blood-thinning effects. In a study involving 123 patients who were bleeding uncontrollably or needed emergency surgery, Praxbind de-activated Pradaxa in 89% of patients within four hours.
It is approved “for managing patients taking Pradaxa, in emergency or life-threatening situations when bleeding can’t be controlled.”
Reversing the effects of a blood-thinning medication is essential during emergencies. In the past, when most patients were on warfarin (Coumadin), the antidote was a simple dose of Vitamin K.
As the popularity of new blood-thinners has skyrocketed, so have the number of adverse events involving uncontrollable bleeding. Most of these new drugs still lack reversal agents — including Xarelto, Eliquis, and Savaysa.
Thousands of lawsuits accuse drug-makers of downplaying the risk of uncontrollable bleeding. Boehringer Ingelheim faced more than 9,000 Pradaxa lawsuits until last year, when they paid $650 million (average of $150,000 per case) to settle the litigation. Bayer Healthcare and Janssen Pharmaceuticals are currently facing around 1,700 federal lawsuits involving Xarelto.
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