A Michigan man has filed a lawsuit after he allegedly suffered Xarelto internal bleeding injuries.

Plaintiff Walter C. says he began taking the blood thinner in December 2013.

Xarelto, made by Janssen Pharmaceuticals, Johnson & Johnson and Bayer Healthcare, became available in the United States in July 2011. Along with Pradaxa and Eliquis, Xarelto belongs to a class of drugs known as New Oral Anticoagulants (NOACs). These NOACs were hailed as the next generation of blood-thinning drugs that could replace warfarin (Coumadin), that had been an established and relatively safe blood thinner for decades.

Warfarin does need blood monitoring on a regular basis to ensure a therapeutic level of the drug is maintained in the bloodstream. However, in the event of an emergency, an IV-administered dose of vitamin K will counteract warfarin’s anti-coagulating effects. Doctors in every emergency room in the U.S. know how to administer this life-saving antidote, alleges the plaintiff in his lawsuit.

Xarelto’s marketing and advertising was directed at consumers, who were encouraged to try the “Xarelto Difference.” The marketing touted Xarelto as an easy once-a-day medication that did not need regular blood tests to ensure a therapeutic level was maintained. Xarelto also was advertised as allowing the patient to experience no dietary restrictions, unlike warfarin.

“However,” alleges the Xarelto internal bleeding complaint, “Xarelto’s clinical studies show that Xarelto is safter and more effective when there is blood monitoring, dose adjustments and twice a day dosing.”

Xarelto Internal Bleeding Risks

Xarelto’s anticoagulant properties stem from its action of inhibiting Factor Xa, an enzyme needed in the process of blood clotting.

Patients who are susceptible to deep vein thrombosis (DVT) and pulmonary embolisms (PE) often are prescribed a blood thinner to reduce the chances of a blood clot. Patients who have atrial fibrillation (irregular heartbeat) are at a higher risk of heart attack or stroke because of the possibility of the blood pooling for too long before recirculating. These patients also can reduce their risk of stroke or heart attack by taking a blood thinner.

According to the Xarelto internal bleeding lawsuit, the FDA approved the new drug despite allegations there were irregularities found in Xarelto’s clinical studies.

The FDA issued a statement that said inspections of the drug makers’ research conducted in 2009 revealed the “systemic discarding of medical records” and concerns of improper randomization in the clinical trial known as the RECORD studies.

Xarelto also was compared to warfarin in a study known as ROCKET AF, but the FDA alleged the warfarin group was not adequately controlled for the comparison to be valid.

According to FDA’s Serious Adverse Event (SAE) Medwatch reports, a total of 1,080 Xarelto reports were filed in the year ending June 30, 2012. Among those, sixty-five deaths were reported.

“At the close of the 2012 fiscal year, a total of 2,081 new Xarelto-associated SAE reports were filed with the FDA, its first full year on the market, ranking tenth among other pharmaceuticals in direct reports to the FDA,” alleges the Xarelto internal bleeding lawsuit, which says 151 of those cases resulted in death.

No warnings were issued to patients or health care professionals regarding the Xarelto internal bleeding dangers, despite the SAE data, alleges Walter’s lawsuit.

The Xarelto Internal Bleeding Lawsuit is Case No. 2:18-cv-06926-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.