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FDA Approves Praxbind: Blood-Thinner Reversal Agent


October 16, 2015 — Boehringer Ingelheim has been granted FDA approval for Praxbind, an intravenous (IV) antidote to the blood-thinning drug Pradaxa.

In a study of 123 patients who needed emergency surgery or were bleeding uncontrollably, Praxbind stopped the effects of Pradaxa within four hours in 89% of patients, according to the FDA. It is approved for “emergency or life-threatening situations when bleeding can’t be controlled.”

Pradaxa was the first once-daily pill designed to replace warfarin (Coumadin), a blood-thinner that had been on the market since the 1950s. Warfarin is a cumbersome drug, but its one advantage is that a dose of Vitamin K reverses its blood-thinning effects.

When Pradaxa hit the market in 2010, it was promoted as superior to warfarin. However, until today, Pradaxa had no reversal agent. As the popularity of Pradaxa skyrocketed, so did the number of adverse events involving uncontrollable internal bleeding and death.

Even more problematic, Pradaxa was quickly followed by other blood-thinners without reversal agents — Xarelto, Eliquis, and Savaysa.

About 1,700 lawsuits have been filed by people who took Xarelto and experienced severe bleeding. Plaintiffs accuse drug-makers of aggressively pushing Xarelto without adequately warning about the risk of uncontrollable bleeding.

Similar accusations were made against Boehringer Ingelheim in 9,00 Pradaxa lawsuits. Last year, the drug-maker paid a $650 million settlement, or an average of $150,000 per case, to end the litigation. Fortunately, Portola Pharmaceuticals is developing an antidote for Xarelto and Eliquis and expects to seek approval this year, Reuters reports.

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