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

Have a cold? Don't ask your doctor for antibiotics

21 hours ago

Antibiotic resistance is a major threat to public health. Resistance makes it harder for physicians to treat infections and can increase the chance patients will die from an infection. What is more, the treatment ...

Powdered measles vaccine found safe in early clinical trials

Nov 25, 2014

A measles vaccine made of fine dry powder and delivered with a puff of air triggered no adverse side effects in early human testing and it is likely effective, according to a paper to be published November 28 in the journal ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.