New Tool: ProSource
Checkout our packaging and processing solutions finder, ProSource.

Did a Defective Medical Device Impact Clinical Trial Results?

Since the device has been recalled, agencies are now looking into trial results for this popular drug.

All eyes are on Bayer's top-selling anti-clotting drug Xarelto after European and U.S. drug regulators announced they are looking into whether or not a defective blood clotting test device affected a trial involving the product, reported Reuters.

"Due to the defect it is now thought that the INR (international normalised ratio) device may have impacted the clotting results in some patients in the warfarin group," said the European Medicines Agency, according to the published report.

The device in question measures how quickly blood starts clotting, and was recalled in December 2014 after giving falsely low test results, reported Reuters.

EMA said they plan to publish their findings.

Discover Our Content Hub
Access Healthcare Packaging's free educational content library!
Read More
Discover Our Content Hub
How to Honor a Leader
Induction into the Packaging & Processing Hall of Fame is the highest honor in our industry. Submit your leader to be considered for the Class of 2024 now through June 10th. New members will be inducted at PACK EXPO International in Chicago.
Read More
How to Honor a Leader