The family of a man who died after experiencing a Xarelto GI bleed has filed a lawsuit.

Manuel G. allegedly was admitted to the hospital on Jan. 18, 2017 for treatment of a life-threatening and irreversible internal bleed that required blood transfusions. He died on March 8, 2017 after allegedly suffering “severe and permanent personal injuries, pain, suffering, and emotional distress,” according to the Xarelto GI bleed lawsuit.

Xarelto is a blood thinner produced by Johnson & Johnson, Janssen Pharmaceuticals and Bayer. Like Pradaxa and Eliquis, Xarelto is in the drug category known as the New Oral Anticoagulants (NOACs), a class of medications that have been heavily promoted in recent years to replace warfarin (Coumadin), a blood thinner that has been relatively safe and in use for nearly 60 years.

Xarelto was marketed as a preferred alternative over warfarin because the latter requires the patient to undergo periodic blood tests to make sure a therapeutic level of warfarin is maintained. Warfarin patients must take the blood thinner twice a day and adhere to some dietary restrictions.

However, in the event of a bleeding emergency such as an injury or accident, warfarin’s blood clotting effects can be brought under control with an IV dose of vitamin K and the omission of the next dose of warfarin.

According to DIAC, up until the FDA’s May 2018 approval of andexanet alfa (AndexXa by Portola Pharmaceuticals) as an antidote for Xarelto, the NOAC had no available medication that could halt its blood-thinning effects.

Xarelto GI Bleed Allegations

According to the FDA’s adverse events summary there were 2,415 adverse event reports related to gastrointestinal hemorrhages from Xarelto between 2004 and 2015.

Approval of Xarelto to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation was based on a clinical trial 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 found that that Xarelto was not inferior to warfarin in the prevention of stroke or systemic embolism, but also found “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.”

According to the Xarelto GI bleed lawsuit, the drug companies knew or should have known that Xarelto was could produce a life-threatening and irreversible internal bleed. Xarelto’s original U.S. label did not include a warning regarding the lack of an antidote and only included a mention of that fact in the section about overdoses.

Early marketing materials allegedly “overstated the efficacy of Xarelto with respect to preventing stroke and systemic embolism” and failed to mention there was no antidote available at the time.

As a result, patients who saw direct-to-consumer advertisements were unaware that Xarelto’s irreversibility could result in life-threatening internal bleeding that could leave them disabled or could be fatal.

The Xarelto GI Bleed Lawsuit is Case No. 2:19-cv-00310-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.