FDA clears Xarelto blood
thinner despite faulty trial device
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[October 12, 2016]
By Reuters Staff
(Reuters) - The U.S. Food and Drug
Administration on Tuesday said it has determined the widely-used blood
thinner Xarelto to be safe and effective for patients with the heart
condition atrial fibrillation after serious doubts arose over the major
study used to gain approval of the drug.
Xarelto, known chemically as rivaroxaban, won U.S. approval in 2011
after it was shown to be a safe and effective alternative to decades
old warfarin for preventing strokes in a study of more that 14,000
patients with the irregular heartbeat condition. Without treatment,
atrial fibrillation leaves patients five times more vulnerable to
In the study dubbed Rocket-AF, warfarin therapy was monitored using
the Alere Inc INRatio device that has since been recalled over its
potential to generate inaccurate results, casting a shadow over the
value of the large, pivotal clinical trial.
"The FDA has completed a variety of analyses to assess the impact
that this faulty monitoring device had on the Rocket-AF study
results," the agency said in a statement posted on its website. "The
Agency has determined that effects on strokes or bleeding, including
bleeding in the head, were minimal."
Xarelto, a multibillion-dollar product, is sold by Bayer AG overseas
and by Johnson and Johnson in the United States. It is the market
leader in a popular new class of medicines designed to replace
problematic warfarin, which requires a special diet and regular
monitoring to make sure dosing remains within a limited therapeutic
range to keep it from becoming either too low, which increases
stroke risk, or too high, which greatly raises the risk of serious
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Warfarin, a widely used and inexpensive generic medicine, is also
sold by Bristol-Myers Squibb under the brand name Coumadin.
Bristol-Myers and Pfizer also sell the Xarelto rival Eliquis.
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