A patient claims that Xarelto GI bleeding was a severe side effect of the blood thinner, and that Johnson & Johnson did not warn patients of the danger.

Plaintiff Arlene S. claims that she took Xarelto from around December 2015 to March 2016. She claims that in March 2016, she exhibited symptoms of experiencing GI tract bleeding, so she was sent to the hospital.

She claims that once at the hospital, she was diagnosed with severe GI bleeding, and required ongoing, extensive care and treatment. Allegedly, she sustained severe and permanent injury from the bleed, which she claims was caused by her use of Xarelto.

The Xarelto GI bleeding lawsuit claims that Johnson & Johnson and Bayer Corporation, along with affiliate companies, developed Xarelto as an anticoagulant, or blood thinner used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis and pulmonary embolism, to reduce the risk of deep vein thrombosis and pulmonary embolism, and to prophylactically address the risk of deep vein thrombosis in patients undergoing hip and knee replacement surgery.

The Xarelto GI bleeding side effect lawsuit states that Xarelto was approved for use to prevent blood clots by patients undergoing knee and hip replacement surgeries in July 2011, and in November of that year was approved for use by patients with non-valvular atrial fibrillation. In November 2012, Xarelto was approved to treat deep vein thrombosis and pulmonary embolism.

The companies advertised Xarelto as being the first blood thinner that did not require routine blood monitoring, and it was advertised as a safe and effective way to prevent blood clots. Other blood thinners require patients to alter their dietary habits, and must be regulated by a doctor, but Xarelto was marketed as easier for patients to use because it came with fewer requirements.

But according to Arlene and other plaintiffs, a study showed that Xarelto was more likely than warfarin (another popular blood thinner on the market) to cause gastrointestinal bleeding and require blood transfusions. The Xarelto GI bleeding warning lawsuit claims that the website advertising the drug noted this fact, but that this information was not included anywhere on the boxed warning for the drug.

Arlene claims that the warning for the Xarelto GI bleeding side effect was inadequate because it was not included on the box or the label, which is what most patients look at before they take the drug.

Additionally, Arelene noted that Food and Drug Administration clinical reviewers have stated that rivaroxaban, the generic name for Xarelto, “should not be approved unless the manufacturer conducts further studies to support the efficacy and safety of [the drug],” because “[a]dverse reports of thrombocytopenia and venous thromboembolic events were identified” in relationship to Xarelto. Allegedly, this information was not included on the drug’s warning label.

Arlene claims that Johnson & Johsnon and Bayer Corporation insufficiently warned patients of the risk of GI bleeding, and failed to warn patients of reservations expressed by the FDA on the level of testing done on the drug, and its safety and efficacy.

The Xarelto GI Bleeding Side Effect Lawsuit is Case No. 2:18-cv-05568-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana.