A woman from Alabama has filed a legal claim alleging she suffered Xarelto gastrointestinal bleeding that could have ended her life.

Plaintiff Elenor A. says she started taking Xarelto in mid-November 2015. After only ten days of treatment, she says she suffered an episode of Xarelto gastrointestinal bleeding.

Elenor now accuses Xarelto’s manufacturers of failing to properly address the risk of bleeding associated with this drug. She names as defendants Janssen Pharmaceuticals Inc., Johnson & Johnson Co., Bayer Healthcare Pharmaceuticals, and their related companies. All these companies allegedly had a hand in the development, manufacture or marketing of Xarelto.

What is Xarelto?

Xarelto is an anticoagulant medication. It’s also known by the generic name rivaroxaban.

Xarelto is now frequently prescribed for patients with atrial fibrillation as a way to reduce the risk of stroke associated with that condition. It’s also FDA-approved to treat and prevent other clot-related conditions like pulmonary embolism and deep vein thrombosis.

Xarelto is one of a few new anticoagulants that were developed to supplant the market dominance held by warfarin, a much older drug sometimes sold under the brand name Coumadin.

Xarelto is designed to be more convenient than warfarin. Patients taking Xarelto do not have to restrict their diet or submit to regular blood testing, as do patients who take warfarin. Xarelto also uses a convenient once-daily dosing schedule.

The Risk of Xarelto Gastrointestinal Bleeding

But with Xarelto treatment comes a risk of Xarelto gastrointestinal bleeding. To one degree or another, this risk is inherent in treatment with any anticoagulant. The action that prevents dangerous blood clots from forming also inhibits the body’s natural means of slowing and stopping bleeding when it occurs.

As a result, patients who take Xarelto are at a greater risk for bleeding. Conditions like gastrointestinal bleeding and intracranial hemorrhage are known hazards associated with Xarelto treatment.

Elenor argues the makers of Xarelto didn’t do enough to warn her and other patients about the dangers of Xarelto bleeding. She says Janssen Pharmaceuticals and the other defendants knew about these risks based on the results of clinical studies and aftermarket reports, yet still failed to issue a proper warning to patients or their doctors.

She cites clinical studies used to earn FDA approval for Xarelto, in which the results showed Xarelto patients more frequently suffered bleeding severe enough to require blood transfusions.

Another study’s results showed that, compared to warfarin, Xarelto was linked to a higher incidence of gastrointestinal bleeding.

Elenor also takes issue with Xarelto’s once-daily dosing schedule. She cites clinical reviewers from the FDA who noted that Xarelto blood levels would be more consistent with twice-daily dosing. One reviewer speculated that the once-daily schedule was intended more for marketing advantage than for clinical benefit.

Elenor claims she was not fully aware of the associated bleeding risk when she chose to take Xarelto, and was unaware there was no reversal mechanism. She says that if she had been given a better warning, she would have avoided taking Xarelto entirely.

Elenor’s Xarelto Gastrointestinal Bleeding Lawsuit is Case No. 2:17-cv-01424, in the U.S. District Court for the Eastern District of Louisiana.