The Food and Drug Administration is investigating the validity of the approval of Xarelto, an anticoagulant drug, based on the possibility of a faulty blood-testing monitor tainting the results of a clinical trial.
Since its arrival on the market in 2011, Xarelto has been prescribed to millions of people in the United States. It is used to reduce a patient's risk of blood clots in conditions such as deep-vein thrombosis and pulmonary embolism, or to prevent strokes and other clotting events.
A legal brief was filed in federal court on Monday that showed that the FDA has questioned Johnson & Johnson, the manufacturer of Xarelto, about their knowledge of any possible malfunctioning of the blood-testing device during the time of the trial. The device that was used in the trial was the INRatio, sold by Alere.
Rocket AF, which was the Xarelto clinical trial led by Dr. Robert M. Califf from 2006 to 2010, included more than 14 thousand patients.
Lawyers representing patients who claim they were injured due to the use of Xarelto also cited internal company documents in the legal brief that showed that doctors complained to the leadership of the trial during the time of the study.
Johnson & Johnson and Bayer, the company that sells Xarelto overseas, notified regulators last year that the blood-testing device used in the clinical trial was recalled due to understating the risk of bleeding.
There are many lawsuits filed throughout the country by individuals who suffered serious, uncontrolled bleeding while on Xarelto. The allegations against the drug manufacturer include a failure to advise routine monitoring to gauge a patient's risk of bleeding.
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