Xarelto bleeding injuries and ultimately death have resulted in a lawsuit against Janssen Pharmaceuticals, Johnson & Johnson and Bayer.

Plaintiff Noela H., the daughter of Elena V., has filed suit because her mother died after taking the blood thinner for treatment of atrial fibrillation from July 2012 to March 2015, according to the claim.

Noela says Elena suffered acute gastrointestinal bleeding and anemia in December 2014. She then suffered another bout of gastrointestinal bleeding and respiratory failure in March 2015. She died March 31, 2015.

Risks of Xarelto Bleeding Injuries Not Disclosed

Xarelto was marketed as a convenient alternative to warfarin (Coumadin), which has been a trusted anticoagulant for more than 50 years.

In the event of surgery or injury, a patient taking warfarin can be given vitamin K to counteract the drug’s blood thinning effects. Warfarin patients need to have blood levels of the medication monitored to assure a therapeutic dose is maintained in the body.

Xarelto bleeding injuries are more dangerous because there is no antidote available for Xarelto. If a patient’s bleeding from an accident or other cause, there is no drug that can stop the anti-coagulating effects of Xarelto.

Xarelto has been promoted as a single daily dose pill, touted as the “Xarelto Difference.” Xarelto is also promoted as setting a patient free from blood monitoring.

The FDA’s reviews of the medication questioned the once daily dose, stating that clinical pharmacology studies suggested twice daily dosing would “produce lower peak blood levels and higher trough blood levels of Xarelto” and “might have been associated with a greater efficacy and/or a better safety profile.”

However, the Xarelto bleeding injuries lawsuit contends, “The use of Xarelto without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events. Physicians using Xarelto have to be able to balance the dose so that the blood is thinned enough to reduce the risk of stroke, but not thinned so much as to increase the risk for a major bleeding event.”

Up until June 30, 2012, 1,080 Xarelto “Serious Adverse Event” reports were filed with the FDA, including 65 deaths. At the end of the 2012 fiscal year, 2,081 adverse events were filed with the FDA and of those, 151 resulted in death. Only 56 deaths were affiliated with warfarin during that same time period.

The risks and need for blood monitoring were not disclosed to patients, doctors or the FDA, the plaintiff claims. Xarelto’s manufacturers are accused of designing their clinical studies to under-report the true risk of Xarelto bleeding injuries in order to secure an increased market share among competing blood thinners.

The Xarelto bleeding injuries complaint claims the manufacturers failed to warn Elena and her doctors of the “need for blood monitoring, dose adjustments and failed to warn of the risk of serious bleeding that may be irreversible, permanently disabling, and life-threatening.” Noela argues that Xarelto is “defective and unreasonably dangerous to foreseeable consumers.”

The Xarelto Bleeding Injuries Lawsuit is Case No. 2:17-cv-05982-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana.