The makers of Xarelto, an anticoagulant that was credited as a breakthrough in blood clot prevention, is battling numerous lawsuits. An alleged connection between an elevated risk for serious hemorrhages and Xarelto are now being lent possible increased credibility through recent studies, reports the Digital Journal.
The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011. It is manufactured by Bayer AG and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The initial purpose of the medication was to prevent blood clots in patients with pulmonary embolisms, deep vein thrombosis, and those recovering from knee and hip replacement surgeries. A short while after it was approved, Xarelto’s uses were expanded to treat atrial fibrillation, a heart condition that increases the risk of stroke.
A preliminary study was conducted by Drs. John C. Hwang and Judy H. Hun on their own patients who were taking Xarelto. They became concerned 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 increased in patients who had changed to Xarelto from a more established blood thinner, according to the Digital Journal.
Coumadin (warfarin), a blood thinner approved for more than 60 years, has a stringent regular blood test requirement as well as dietary restrictions, but has the safety of an antidote in case of excessive bleeding. Xarelto, although more convenient for the patient, has no such antidote at the present time.
Over 2,800 lawsuits claiming harm from Xarelto use have been combined by the U.S. Judicial Panel on Multidistrict Litigation. In the Easter District of Louisiana, Judge Eldon Fallon will try cases in multidistrict litigation (MDL). More cases against Xarelto are expected to be added to the mass litigation as the court dates approach, the Digital Journal reports.