Research Studies Support Claims of Increased Bleeding Risks in Xarelto Users

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New research studies support claims that the blood-thinning drug Xarelto increases bleeding risks, including eye bleeds.

Side effects and complications associated with Xarelto have sparked concerns in the medical community and the public and have resulted in thousands of lawsuits.

Xarelto (rivaroxaban) received Food and Drug Administration (FDA) approval in 2011, the first in a new generation of blood thinners that was hailed as a breakthrough clot prevention treatment. Xarelto promised freedom from the burdensome restrictions imposed on users of the older blood thinner warfarin, Digital Journal reports.

Xarelto was approved as a treatment to prevent clots in people with pulmonary embolisms, deep vein thrombosis, and in patients at risk for clots after hip and knee replacement surgeries. Approval was later expanded to include Xarelto use to prevent strokes for individuals with atrial fibrillation, a heart rhythm abnormality.

The enthusiastic reception for Xarelto has diminished in the face of steadily mounting adverse event reports alleging a connection between Xarelto and strokes, clots, pulmonary embolisms, and uncontrollable bleeding. Concerned about the potential bleeding risks, Drs. John C. Hwang and Judy H. Hun conducted a preliminary study of patients aged 70 to 89 in their ophthalmology practice who were taking Xarelto at the time. The doctors found that at least three patients had developed “spontaneous vitreous hemorrhage,” eye bleeding. The study further revealed that the potential for such adverse events seemed elevated in patients who had switched to Xarelto from a more traditional anticoagulant, Digital Journal reports. Their research was published in the June 2015 issue of JAMA Ophthalmology.

A national study of gastrointestinal bleeding compared more than 46,000 patients taking the blood thinners warfarin (39,607), Pradaxa (4,907), and Xarelto (1,649). Data indicated that after two years there was “as much as a 50 percent increase in the risk of gastrointestinal bleeding with dabigatran [Pradaxa] compared with warfarin or a twofold higher risk of bleeding with rivaroxaban (Xarelto) when compared with warfarin.”

More than 2,800 Xarelto cases have been consolidated in a multidistrict litigation (MDL), and another 550 cases have been organized in a mass tort program on the state level in the Pennsylvania. The cases in the two litigations share a number of common allegations, including claims that the drug makers Bayer AG and Janssen Pharmaceuticals (a division of Johnson & Johnson) put Xarelto users at undue risk of harm and that the anticoagulant is responsible for serious injuries the plaintiffs suffered.

Plaintiffs blame the drug makers for bringing Xarelto to market with no known antidote for bleeding episodes. Warfarin, despite its restrictions, has a readily available antidote that can help restore clotting ability and stop a bleeding episode.

In addition to bleeding concerns, a recently filed lawsuit raises another concern: the proper dose of Xarelto. The man claims that the once-daily dose of Xarelto was not effective for him. He suffered a stroke just four days after beginning to take Xarelto to reduce stroke risk. All patients currently receive the same dose of Xarelto, regardless of their size or weight, but some patients may need a higher dose, and patients may need monitoring to be sure they are taking an effective dose.