The U.S. Food and Drug Administration and the European Medicines Agency are investigating whether a potentially defective blood-clotting test device skewered data in a Xarelto study. The possibility of a tainted study was first reported by the German newspaper Handelsblatt.
Xarelto is a new anticoagulant meant to prevent blood clots, strokes and heart attack in patients, including those who underwent heart surgery. The Xarelto study in question was funded by manufacturer Bayer Pharmaceuticals and compared the drug to the older alternative warfarin in treatment of patients with systemic embolism and irregular heartbeat.
The defective test device may have skewed data pertaining to warfarin, which would have indicated a better benefit-risk profile for Xarelto, which has come under fire for its link to an increased risk of severe side effects. Thousands of patients have complained of Xarelto side effects, including internal hemorrhaging. Patients have begun filing Xarelto lawsuits alleging that the drug caused serious injuries.