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BMJ Report Questions Whether Defective Inratio Monitors Tainted Xarelto Clinical Trials

BMJ report suggests that Janssen knew about problems with Alere INRatio PT/INR monitoring systems, but failed to inform regulators about these issues.

A new report from The BMJ suggests that Janssen Pharmaceuticals knew about problems with Alere INRatio PT/INR monitoring systems used during a clinical trial to test the safety of Xarelto (generic: rivaroxaban), but failed to inform regulators about those issues.

Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by an Alere INRatio monitor, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the Problem?

October 19, 2016 – The report (PDF), published online Sept. 28, covers an investigation by The BMJ into whether Janssen and Bayer, co-makers of Xarelto, knew about problems with the INRatio monitor.

INRatio devices were used during the ROCKET AF trial, which compared Xarelto to warfarin for the treatment of nonvalvular atrial fibrillation (a-fib). Results from the trial were used to support INRatio’s approval on the U.S. market.

The monitoring system is used to determine how quickly a patient’s blood is clotting, which is vital for patients who take blood-thinner drugs. INRatio compares how quickly the patient’s blood clots to the International Normalized Ratio (INR) test. Based on the results produced by the device, a patient’s dosage of the medication could be increased or decreased.

Xarelto is a blood-thinner medication, and to test its safety before entering the market it was put through the ROCKET AF trial, during which its results were compared with warfarin, a standard anticoagulant that’s been in use for over 60 years in the U.S. The INRatio monitor was used to find how quickly test subjects’ blood clotted when they took warfarin.

In December 2014, however, Alere recalled its INRatio Test Strips due to reports of abnormal readings that could result in patients having their dosage of a blood-thinner increased, which also increases the risk of an adverse bleeding event.

The ROCKET AF trial concluded that Xarelto and warfarin had no significant difference in regards to the bleeding risk, but did link warfarin to an increased risk for fatal bleeding in the brain (cerebral hemorrhage). However, if patients were exposed to unnecessarily higher doses of warfarin due to faulty data from an INRatio monitor, results of the study could be skewed, making Xarelto appear safer than it actually is.

Do I have an Inratio Lawsuit?

The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Inratio lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Free Case Evaluation: Again, if you or a loved one was injured, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

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