A man has taken legal action against pharmaceutical companies, alleging the companies failed to adequately warn about the side effects of their drug.

Plaintiff William T. says Xarelto is dangerous, and he has filed suit against Janssen Research, Johnson & Johnson and Bayer Corporation.

Xarelto (rivaroxaban) is a blood thinner that is expected to exceed $1 billion in sales this year.

Xarelto belongs to a new breed of anticoagulants called Factor Xa inhibitors. The drug maker promotes uniform doses in everyone, but some people can tolerate it better than others. The main side effect is bleeding, but it can range from minor bleeding all the way to being fatal.

The FDA approved Xarelto in July 2011 for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgeries.

The drug was additionally approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation in November 2011.

In November 2012, Xarelto was approved to reduce the recurrence of DVT and PE.

William was prescribed Xarelto in April 2012 for the reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation.

On Feb. 16, 2015, William was admitted to the hospital, suffering from rectal bleeding and anemia. He received blood transfusions and other medical treatment and was discharged on Feb. 23, 2015.

Claiming Xarelto is dangerous because it directly and proximately caused William’s injuries, doctors discontinued the medication.

Why Xarelto Is Dangerous

Xarelto has been marketed as a great alternative to Coumadin, generically known as warfarin, which has been around for about 50 years.

When on warfarin, a patient needs to take INR (international normalized ratio) blood tests to determine how fast the blood clots. This test helps maintain the right dosage.

If for some reason a patient needs to have warfarin’s anticoagulant properties cease due to accident or injury, a number of options for reversal are available, including vitamin K.

One of Xarelto’s biggest selling points is that it does not need any testing in order to ensure a therapeutic level is maintained and that it is a once daily dose. In fact, this convenience has been promoted as the “Xarelto Difference.”

However, patients tolerate Xarelto differently, which means Xarelto is dangerous to patients who are more prone internal bleeding injuries.

The Institute for Safe Medication Practices noted in 2012 that during the FDA’s review process of Xarelto, “reviewers questioned the convenient once-a-day dosing scheme” of Xarelto because blood level studies had suggested that “twice daily dosing, which would produce lower peak blood levels and higher trough blood levels of (Xarelto), might have been associated with greater efficacy and/or a better safety profile.”

Currently, there is no antidote for the new blood thinner. Xarelto is dangerous, critics say, because if a person experiences Xarelto bleeding problems, a doctor cannot control that bleeding.

Xarelto Study Pointed to GI Bleeding Problems

The drug maker conducted a clinical trial known as the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation study (“ROCKET AF”).

According to the lawsuit, ROCKET AF proved Xarelto was “non-inferior to warfarin for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation, with a similar risk of major bleeding.”

Still, “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban (Xarelto) group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.”

The Xarelto Bleeding Lawsuit is Case No. 2:17-cv-01167-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.