October 4, 2016 — Janssen Pharmaceuticals hid their concerns about a faulty blood-testing device used in a clinical trial of Xarelto, according to an investigation by the British Medical Journal.
Janssen set up a safety recheck program in 2008 after investigators became concerned about accuracy of the device, but did not tell the safety monitoring board for the trial.
This may have put patients at unnecessary risk, said the BMJ. Faulty devices could have caused some patients on warfarin to experience bleeding. Extra bleeding events in warfarin patients might have also skewed results of the study in favor of Xarelto, but Janssen did not tell the FDA about their concerns before Xarelto was approved.
Bayer and Janssen are now facing over 10,000 lawsuits from people who experienced uncontrollable bleeding after taking Xarelto.
The device is the Alere INRatio System, which measures blood-clotting times (known as “INR”). It was recalled in July 2016 because it produces low readings that could cause a patient to overdose on warfarin and experience severe, life-threatening bleeding.
The Xarelto clinical trial — ROCKET-AF — enrolled its first patient in December 2006, about a month after the FDA issued its second warning about problems with faulty INRatio readings. The FDA warned INRatio’s manufacturer for failing to act on complaints about low readings in October 2005 and November 2006.
ROCKET-AF was led by Dr. Robert Califf at Duke University, who became commissioner of the FDA soon after the study ended. Xarelto is now a blockbuster drug that generates over $5 billion a year in sales.
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