FDA Approves First Reversal Agent for Pradaxa

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.

However, Portola Pharmaceuticals is developing an antidote for Xarelto and Eliquis. Portola plans to seek FDA approval for the drugs before the end of this year, according to Reuters.

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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