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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.

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Discover the right packaging solutions for life sciences in Philadelphia
Explore innovative packaging and supply chain solutions for the life sciences at the largest PACK EXPO East in history, March 18–20. Get ideas from 400+ top exhibitors and connect with colleagues and industry experts—all in one convenient location!
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Discover the right packaging solutions for life sciences in Philadelphia