FDA Backs Xarelto Benefits Despite Recalled Clinical Trial Device

FDA Backs Xarelto Benefits Despite Recalled Clinical Trial Device

After critics accused Johnson & Johnson and Bayer of hiding data in clinical trials for their blockbuster blood thinner Xarelto (rivaroxaban), the U.S. Food and Drug Administration said the drug is safe and effective.

Since its approval in 2011, Xarelto has made billions for J&J and Bayer. On Oct. 11, 2016, the FDA released its reanalysis of the ROCKET AF clinical trial data — the original trial used to approve Xarelto. According to the agency, the drug is still a safe and effective alternative to warfarin despite a faulty device used in the clinical trials.

The FDA conducted the reanalysis after The BMJ and other critics questioned trial results following the discovery that the INRatio — a device used to administer warfarin to patients in the trial — was faulty. In 2014, the FDA recalled the INRatio device because it could deliver significantly lower results than a lab method, resulting in warfarin patients receiving too high of a dose and an increased risk of bleeding. Alere, the device’s manufacturer, said it received 18,924 reports of malfunctions, 14 of which led to serious injuries.


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This post originally appeared here: https://www.drugwatch.com/news/2016/10/17/fda-backs-xarelto-benefits-despite-recalled-clinical-trial-device/

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