A woman from Oklahoma is bringing a claim against Janssen Pharmaceuticals after suffering what she believed was an episode of Xarelto GI bleeding.

Plaintiff Norma S. says she started taking Xarelto in February 2015. She kept taking it for about eight months, then stopped in October 2015 after she developed lower gastrointestinal bleeding.

Norma now alleges her lower GI bleeding episode was caused by the Xarelto she took. She believes she could have avoided developing this complication had defendants Janssen Pharmaceuticals, Johnson & Johnson, Bayer Healthcare Pharmeceuticals, and their related companies issued more effective warnings about Xarelto GI bleeding.

Xarelto Background

These defendant companies are all involved in the manufacture of Xarelto, a relatively new anticoagulant medication.

Like other anticoagulants, Xarelto is often used to reduce the risk of stroke associated with atrial fibrillation. It’s also FDA-approved to treat other blood clot-related conditions like deep vein thrombosis and pulmonary embolism, and to prevent those conditions from recurring.

Xarelto and other new anticoagulant drugs were designed specifically to avoid certain drawbacks associated with warfarin, the anticoagulant that dominated the market for decades. Patients who take Xarelto don’t have to submit to regular blood testing or dietary restrictions like warfarin patients do.

Norma argues that the manufacturers of Xarelto knew that Xarelto was linked to GI bleeding based on the results of several clinical trials:

• The RECORD studies, conducted to support the first round of FDA approval for Xarelto, compared Xarelto to enoxaparin, another anticoagulant. Researchers found that Xarelto was linked to a higher  incidence of bleeding that led to decreased hemoglobin levels and the need for blood transfusions.
• Later, the ROCKET-AF study compared Xarelto to warfarin. Researchers there reported that “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban [the generic name for Xarelto] group”.
• Studies in the EINSTEIN group found that compared to a placebo, Xarelto came with a heightened risk of bleeding events. These studies showed a higher rate of adverse events in Xarelto patients, including events that resulted in prolonged hospitalization or permanent discontinuation of Xarelto.

Norma also takes issue with the once-daily dosing schedule for Xarelto. She quotes FDA reviewers who expressed concern that once-daily dosing would put patients at greater risk. One reviewer speculated that the dosing schedule may have been selected more to gain a marketing advantage than for any clinical benefit.

Plaintiff: Xarelto GI Bleeding Could Have Been Avoided with Better Warning

All this available information put the defendants on notice that Xarelto has a tendency to lead to excessive bleeding, according to Norma’s Xarelto lawsuit.

Norma believes the defendants failed in their duty to pass this information on to patients like herself. She alleges the warnings and product information for Xarelto fail to get across to patients and their doctors the true nature of these risks.

She says that if she had been given a better warning about the risk of Xarelto GI bleeding, she would have refrained from using Xarelto.

This Xarelto GI Bleeding Lawsuit is Case No. 2:17-cv-01185, in the U.S. District Court for the Eastern District of Louisiana.