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Problem with device in Xarelto trial dates back to 2002

April 5th, 2016

A device that was used in a prominent Xarelto study likely gave falsely low results in favor of the drug’s efficacy, and the problem with the device dates back to 2002. According to a study published by the editors of the British Medical Journal, the faulty device could have made Xarelto seem safer than it really is when it comes to bleeding risks.

According to the study, during the trial the faulty device led participants and their doctors to think that their levels of warfarin, a competing anticoagulant, were lower than they were. Doctors would then give more of the drug to the patient, causing a higher rate of bleeding than Xarelto. More than 13 million prescriptions of Xarelto have been given out since the drug was approved and marketed as a safer alternative to warfarin.

However, many patients have reported serious Xarelto side effects related to the drug, including internal hemorrhaging and blood clots that led to heart attacks and stroke. Thousands of Xarelto lawsuits have been filed against drug manufacturer Bayer Pharmaceuticals alleging that the company failed to warn doctors and patients of the increased risks of serious side effects associated with Xarelto.


CBS News

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