Kcentra approved to stop severe bleeding in heart patients

(HealthDay)—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 products.

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 () 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 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.

More information: To learn more about this approval, visit the FDA.

add to favorites email to friend print save as pdf

Related Stories

Varizig approved to reduce chickenpox symptoms

Dec 22, 2012

(HealthDay)—Varizig (varicella zoster immune globulin) has been approved by the U.S. Food and Drug Administration to minimize chickenpox symptoms when administered within four days of exposure to the virus ...

Octaplas approved for blood-clotting disorders

Jan 17, 2013

(HealthDay)—Octaplas has been approved by the U.S. Food and Drug Administration to augment insufficient clotting proteins that could otherwise lead to excessive bleeding or excessive clotting.

Recommended for you

WHO: Millions of Ebola vaccine doses ready in 2015

7 hours ago

The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines will start being tested in March.

Added benefit of vedolizumab is not proven

Oct 23, 2014

Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the ...

Seaweed menace may yield new medicines

Oct 22, 2014

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

User comments