March 18, 2016
Public Citizen Calls on FDA to Remove Unsafe, Unreliable Blood Testing Device and Raise Standards for Approval of Similar Devices
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) should finish its investigation of INRatio’s unsafe and unreliable blood testing device and seriously consider removing it from the market. That’s what Dr. Sidney Wolfe, founder of and senior adviser to Public Citizen’s Health Research Group, will tell CDRH representatives at a workshop on Friday, March 18.
The device, used in an industry-funded clinical trial called ROCKET AF, has been the subject of nearly 10,000 malfunction reports and nearly 1,500 injury reports to the FDA since 2002, when it was first marketed to people using a commonly prescribed blood thinner, warfarin, a Public Citizen analysis of FDA records showed.
False readings by the device may have skewed the trial results in favor of the anticoagulant being tested – rivaroxaban (brand name Xarelto, manufactured by Janssen/Bayer) – which the FDA ultimately approved based on the results of this trial. The FDA’s Center for Drug Evaluation and Research (CDER) is still investigating the impact of this faulty device on the results of ROCKET AF.
Five parties – the CDRH, CDER, Janssen/Bayer, ROCKET AF investigators and the INRatio device manufacturers – were not responsibly or promptly communicating with each other more than 10 years ago, when serious problems with this blood testing device’s reliability were first discovered, Wolfe will tell workshop participants.
Wolfe’s presentation will detail problems with the blood testing device and the clinical trial, and show that the responsible parties failed to act on their knowledge of these serious issues.