The anti-blood clotting drug Xarelto has come under scrutiny of late due to injuries that people who have been prescribed the drug have allegedly suffered. Several lawsuits in differing jurisdictions have been filed. The first trials are set to begin next year.
As part of the investigation into claims of injury, the initial trials of the drug are being called into question. Drug regulators in Europe and the United States are looking into whether a defective device used to test blood clotting may have affected a trial. The trial pitted the drug against Xarelto against long-standing treatment Warfarin.
The European Medicines Agency (EMA) reported that a faulty INR (international normalized ratio) device may have impacted the clotting results for people in the Warfarin group. An INR device is used to test how quickly blood starts clotting.
The INR device in question was the Alere INRatio and the Alere INRatio 2. Both were recalled in December of 2014 after giving false low results.
However, Bayer and the Clinical Research Institute at Duke University where some of the trials were completed used the device in question. However, they also report having conducted fresh analysis whose results indicated that the faulty device did not impact the trial results.
The U.S. Food & Drug Administration made a statement that they were aware of the concerns. They are currently in the process of reviewing relevant data.
A spokesperson for Bayer made a statement, “Bayer is working closely with health authorities to address any questions they may have. Study after study confirms that Xarelto is performing as expected with a positive beneift-risk profile.
If you have been injured as a result of taking the prescribed drug Xarelto, you may be entitled to compensation. Contact the law offices of John Foy & Associates to discuss your case. The “Strong Arm” attorneys will work to get you the compensation you deserve. Contact us today.