European and U.S. drug regulators are looking into whether a defective blood-clotting test device affected a trial involving Bayer’s blockbuster anti-blood clotting drug Xarelto, hitting the German drugmaker’s shares.
The study compared Xarelto, also known as rivaroxaban, with older drug warfarin for the prevention of stroke and systemic embolisms in patients with a type of irregular heartbeat that is common among the elderly.
“Due to the defect it is now thought that the INR (international normalized ratio) device may have impacted the clotting results in some patients in the warfarin group,” the European Medicines Agency said in a statement, adding it will publish the results when the investigation is complete.
