Oct 11 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 strokes.
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
"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 & 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 bleeding.
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
(Reporting by Bill Berkrot; Editing by Bernard Orr)