An alleged wrongful death caused by Xarelto has resulted in a lawsuit against the makers of the new anticoagulant.

A woman claims her husband took Xarelto from January 2015 to May 2015. He suffered severe bleeding that began May 29, 2015 and died of his injuries May 31, 2015.

Xarelto, made by pharmaceutical giants Johnson & Johnson, Janssen Pharmaceuticals and Bayer Healthcare, belongs to a class of drugs known as New Oral Anticoagulants (NOACs). Pradaxa and Eliquis are in this class as well. The NOACs are marketed as the next generation of blood-thinners, and slick advertising campaigns try to convince consumers that Xarelto, Pradaxa and Eliquis are better than warfarin (Coumadin), which has been an established blood thinner for 60 years.

In the event of injury or surgery, the anticoagulant effects of warfarin can be stopped with treatment of vitamin K. There is currently no such antidote for Xarelto. When on warfarin, a patient needs to take INR (international normalized ration) blood tests to determine how fast the blood clots. This test ensures a safe dosage is maintained.

Xarelto was FDA-approved in July 2011 for the prevention of Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE) in patients undergoing hip or knee replacement surgeries.

In early November 2011, the FDA additionally approved Xarelto to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, a certain type of erratic heartbeat.

Plaintiff: Bleeding Risk Led to Wrongful Death Caused by Xarelto

According to the plaintiff in this Xarelto lawsuit, a series of clinical trials called RECORD (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism studies) showed that Xarelto was a superior anticoagulant to Lovenox (enoxaparin) to prevent DVT after total knee and hip replacement surgery.

However, the RECORD studies “also showed a greater bleeding incidence with Xarelto leading to decreased hemoglobin levels and transfusion of blood,” says the wrongful death caused by Xarelto complaint.

The wrongful death caused by Xarelto lawsuit also addresses a study known as ROCKET AF (Rivaroxaban Once Daily Oral direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation).

The ROCKET AF study “was not well managed,” according to the FDA.

The Institute for Safe Medication Practices noted in 2012 that during the FDA’s review process of Xarelto’s ROCKET AF study, “reviewers questioned the convenient once-a-day dosing scheme” of Xarelto because blood level studies had suggested that “peaks and troughs that could be eliminated by twice-a-day dosing.”

Dr. Steven E. Nissen said, “My concern was that the dose was selected more for a marketing advantage rather than for the scientific data that was available, and was mistake…”

According to the lawsuit claiming the wrongful death caused by Xarelto, “Xarelto’s clinical studies show that Xarelto is safer and more effective when there is blood monitoring, dose adjustments and twice a day dosing.”

The Wrongful Death Caused by Xarelto Lawsuit is Case 2:17-cv-05160-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.