The clinical trial that was the basis for FDA approval of the blood thinner Xarelto for cardiac patients used a line of testing devices that was the subject of two FDA warning letters before the trial began and an FDA recall notice after the trial ended, a new report from Project on Government Oversight (POGO) says.
The Duke University institute that coordinated the clinical trial told POGO that it is reassessing the trial data to determine how if at all potentially malfunctioning medical devices affected the results.
Robert Califf, a former Duke University researcher who is now President Obama’s nominee to head the FDA, co-chaired the executive committee that designed and oversaw the trial.
Records reviewed by POGO show that the Xarelto trial used “INRatio” blood-testing devices and that, before the trial began, the reliability of certain INRatio devices was the subject of two FDA warning letters. In 2014, four years after the trial ended, an FDA recall notice warned that certain INRatio devices could deliver false test results and that use of those devices may “cause severe or life-threatening injuries, including death.”
A member of an FDA advisory committee that reviewed Xarelto said information about the warning letters should have been available to the advisory committee before it recommended approval of the drug for patients with a heart condition called atrial fibrillation.
Xarelto generated U.S. sales of $1.5 billion last year and has been prescribed for more than 3 million patients in the United States.
“Before voting on Dr. Califf’s nomination, members of the Senate still have time to ask questions. For the health and safety of the public, they should use that opportunity to get the bottom of this matter,” said Danielle Brian, POGO’s executive director. “Why didn’t the people responsible for the clinical trial disclose the potential problem until POGO inquired?”