Xarelto Approved to Prevent Stroke in People With
FRIDAY, Nov. 4 (HealthDay News) -- The anti-clotting drug
Xarelto (rivaroxaban) has been approved by the U.S. Food and Drug
Administration to prevent stroke in people with atrial
fibrillation, a common form of irregular heartbeat.
More than 2 million Americans have atrial fibrillation, in which
the heart's two upper chambers beat irregularly, the FDA said in a
news release. The condition can lead to the formation of a blood
clot, which can travel to the brain and cause a stroke. The new
drug was approved for cases in which the atrial fibrillation is
unrelated to the performance of the heart's valves.
Xarelto's safety and effectiveness were compared to those of
another anti-clotting drug, warfarin, in clinical studies involving
some 14,000 patients. Xerelto was deemed similar to warfarin in its
ability to prevent stroke, the FDA said.
As with other anti-clotting drugs, Xarelto has the ability to
cause bleeding, which in rare cases can lead to death, the agency
The drug's label has the FDA's most urgent "black box" warning
that the drug should never be discontinued before the patient
discusses the situation with a physician. Stopping the drug could
increase the risk of stroke, the FDA warned.
In July, Xarelto received initial approval to reduce a user's
risk of blood clots, deep vein thrombosis and pulmonary embolism
after replacement surgery of the knee or hip.
The drug is marketed by Janssen Pharmaceuticals, based in
To learn more about
atrial fibrillation, visit the U.S. National Heart Lung and Blood Institute.
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