The Studies and Manufacturers of Xarelto. Bayer AG and Janssen Pharmaceuticals (a subdivision of Johnson & Johnson) are manufacturers of Xarelto, an anticoagulant that was embraced as a breakthrough in blood clot prevention. Xarelto has less dietary restrictions and blood monitoring than the established blood thinner Coumadin (warfarin).
However, an alleged connection between an elevated risk for catastrophic hemorrhages and Xarelto has led to numerous lawsuits. The suits are now being lent possibly increased credibility through recent scholarly studies, reports the Digital Journal.
The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011. Its purpose initially was blood clot prevention in those patients with pulmonary embolisms, deep vein thrombosis, and individuals recovering from hip and knee replacement surgeries.
A short while after its approval, Xarelto’s uses were expanded to the treatment of atrial fibrillation, a cardiac condition that increases the risk of stroke.
Drs. John C. Hwang and Judy H. Hun conducted a preliminary study on their own patients who were taking Xarelto.
They became alarmed by the potential danger appearing in reports to the FDA
They became alarmed by the potential danger appearing in reports to the FDA of the alleged connection between Xarelto and strokes, clots, massive pulmonary embolisms, and uncontrollable hemorrhages in patients using the new-generation anticoagulant.
The doctors noted at least three patients had developed “spontaneous vitreous hemorrhage,” also called eye bleeding. Their study also showed that the potential for these adverse episodes appeared to be elevated in patients who had changed to Xarelto from a more established blood thinner, according to the Digital Journal.
Another national study compared patients using three anticoagulants. Drawing on more than 46,000 individual histories, the study compared warfarin (39,607), Pradaxa (4,907), and Xarelto (1,649). After two years, the data seemed to show a clear connection.
The study noted there was “as much as a 50 percent increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin, or a twofold higher risk of bleeding with rivaroxaban (Xarelto) when compared with warfarin.”
Over 2,800 lawsuits claiming harm from Xarelto use have been consolidated by the U.S. Judicial Panel on Multidistrict Litigation in the U.S. District Court for the Eastern District of Louisiana before Judge Eldon Fallon. More cases against Xarelto are expected to be added to the mass litigation in the future, the Digital Journal reports.