-- Scott Roberts
TUESDAY, April 30 (HealthDay News) -- Kcentra (prothrombin
complex concentrate, human) has been approved by the U.S. Food and
Drug Administration to treat severe acute bleeding in adults after
administration of the anti-clotting drug warfarin and similar
Blood plasma is the only other product approved for this use,
the FDA said in a news release, but plasma requires blood typing
and may require thawing. This means Kcentra usually can be
administered more quickly than plasma to stop major bleeding.
Warfarin and similar anticoagulants are typically prescribed in
cases of atrial fibrillation (irregular heartbeat) and for people
with an artificial heart valve, the FDA said.
Kcentra will carry a boxed label warning that it may increase
users' risk of blood clots. Made from the pooled plasma of screened
donors, it's processed to minimize recipients' risk of acquiring
viruses and other germs, the agency said.
In a study of 216 people who had been receiving anticoagulation
therapy and who developed major bleeding, Kcentra was found to be
as effective as plasma in treating the problem, the FDA said.
The drug is produced by the German company CSL Behring.
To learn more about this approval, visit the
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