Cases of uncontrolled bleeding in some patients who took the anticoagulant Xarelto have prompted lawsuits against drug makers Johnson & Johnson and Bayer Healthcare. With no antidote to the bleeding, the drug can cause severe health problems and even death.

One of a new class of anticoagulants, Xarelto was developed by Bayer and marketed in the United States by Janssen Pharmaceuticals, a division of Johnson & Johnson. It was approved in July 2011 to reduce the risk of deep vein thrombosis and pulmonary embolism following joint replacement surgery and for use by people suffering from atrial fibrillation. The manufacturers now plan to broaden its usage to include acute coronary syndrome.

Xarelto is the cornerstone of Bayer’s pharmaceutical business. Annual sales of Xarelto in the United States were expected to top $1 billion dollars last year, and the company has predicted the drug’s sales will eventually top $3.5 billion a year.

The Case Against Xarelto

Xarelto was promoted as superior to Warfarin (also known as Coumadin) because it is easier to take and requires less frequent monitoring to maintain correct dosage. However, unlike Warfarin there is not currently an antidote for the severe bleeding that can be caused by Xarelto, and warnings given to patients and doctors have been insufficient. Blood monitoring, which the manufacturers said was not needed, could actually reduce the risk of Xarelto bleeding injuries.

Thousands of patients using Xarelto have experienced hemorrhages, gastrointestinal bleeding, strokes and even death. A similar case was brought against blood thinner Pradaxa, however more adverse side effects have been reported with Xarelto than with Pradaxa. In June 2016, the Institute for Safe Medication Practices reported that Xarelto was linked to more serious injuries than any other drug monitored. According to the report, the blood thinner accounted for 10,674 reports of fatal, disabling, and serious injuries in 2015.

As of January 2017, there were more than 14,000 Xarelto lawsuits filed in federal court, and many more have been filed in state courts. It is hoped that those patients suffering from uncontrolled bleeding after taking Xarelto will be fully compensated for their injuries, while the manufacturers will be pushed to improve the information they provide consumers and physicians to make an informed choice about whether they want to use Xarelto.

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