Xarelto (rivaroxaban) belongs to a new generation of blood-thinning medications that prevent strokes by changing blood chemistry. It works by preventing blood cells from sticking together and creating clots.

Bleeding is the most common serious side effect of all blood-thinning medications. The problem is Xarelto lacks an antidote to stop its blood-thinning effects, unlike Coumadin (warfarin), which has been on the market since the 1950s and can be reversed with a dose of Vitamin K.

Thousands of lawsuits accuse Bayer HealthCare and Janssen Pharmaceuticals of downplaying this hazard and failing to warn about the risk of uncontrollable bleeding.

There are now more than 1,000 lawsuits pending in a “mass-tort” at the state level in the Philadelphia Court of Common Pleas.

As of December 15, another 14,465 Xarelto lawsuits were pending in a federal Multi-District Litigation (MDL No. 2592) in Louisiana.

Federal trials are set to begin in March 2017. The first state-court cases will go to trial in late 2017, unless a settlement is reached.

Over 4,000 similar lawsuits involving the blood-thinner Pradaxa (dabigatran) settled for $650 million in 2011, for an average per-case payout of $162,500. The FDA approved an antidote to Pradaxa — Praxbind — in 2014.

An antidote for Xarelto called andexanet alfa has been developed by Portola Pharmaceuticals. Clinical trials show that it effectively reverses Xarelto and stops bleeding within a few hours.

Portola estimates that 100,000 patients on Xarelto who experience severe bleeding would need the medication every year.

However, the FDA denied approval for andexanet alfa in August over concerns about manufacturing issues. Researchers recently raised concerns about its safety in an editorial published by the New England Journal of Medicine.

Source: New England Journal of Medicine

Posted by Daily Hornet

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