Last year, the United States Food and Drug Administration (FDA) became aware that a device used to monitor a patient’s blood in Xarelto clinical trials had problems. Now it has been reported by British Medical Journal, and via FiercePharma, that the two major drug companies (Janssen/Johnson & Johnson and Bayer A.G.) were well aware of this faulty blood monitor during the time it was being used and did not notify any of the study monitors or the FDA.
The device in question is known as the INRatio device, and it was designed to monitor how much Xarelto was being absorbed by patients on a single dose as compared to those who were taking Warfarin (Coumadin). The reason this is very important has to do with why drug makers claim Xarelto and the other New Oral Anticoagulants (NOACs) are safer and more effective than traditional blood thinning medications like Warfarin. Continue reading