The European Medicines Agency (EMA) is questioning the results of a clinical trial called ROCKET AF, that compared Xarelto (rivaroxaban) with warfarin for preventing stroke in patients with nonvalvular atrial fibrillation (AFib). A defective device was used in the trial, and regulators are worried that the defect may have resulted in inaccurate results in some patients. The U.S. Food and Drug Administration (FDA) says it is reviewing the data.
Defective Testing Device
The defective device in an international normalized ratio (INR) device. It measures how quickly blood starts clotting. The recall was initiated in December 2014, due to falsely low test results, and affected the Alere INRatio and INRatio2 PT/INR Monitor system. It was a Class I recall which the FDA says is the most serious type of recall.
The EMA is investigating because it says that the defective device may have affected the results in the warfarin patients.
Not the First Problem with Xarelto Trial
This is not the first problem with the Xarelto trial. In 2011, FDA experts found the clinical trial to be biased in favor of Xarelto, but the agency approved the drug anyway. Dr. Robert M. Califf, led the trial, conducted by Duke University’s Clinical Research Institute, using the defective device.
In September, 2015, President Obama nominated Califf to head the FDA. His involvement in the Xarelto trial is just one of the many concerns about a conflict of interest due to his heavy involvement with the pharmaceutical companies.
More than 2,000 lawsuits have been filed against Bayer and Johnson & Johnson alleging that Xarelto caused serious and fatal bleeding as well as other side effects. For more information about Xarelto, please read this article – http://www.usrecallnews.com/xarelto-injury-lawsuits/ and the other articles in this section – http://www.usrecallnews.com/category/medical-devices/xarelto/.
If you have been harmed by a defective drug or medical device, please talk to an experienced defective drug attorney right away to learn more about your rights.