Xarelto, first approved in 2011, is used to treat or prevent blood clots and lower the risk of stroke.
This summer, a device used to monitor the health of more than 14,000 patients in a clinical trial for the drug was recalled for its potential to generate inaccurate results. The recall left some members of the drug industry to question the accuracy of the drug study, called Rocket-AF, and whether the treatment should be used to treat atrial fibrillation patients.
However, the FDA issued a statement on its website saying it “completed a variety of analyses to assess the impact that this faulty monitoring device had on the Rocket-AF study results” and “determined that effects on strokes or bleeding, including bleeding in the head, were minimal.”
New Brunswick, N.J.-based Johnson and Johnson sells Xarelto in the U.S., while Leverkusen, Germany-based Bayer maintains drug sales overseas, according to the report.
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