Kcentra Approved to Stop Severe Bleeding in Heart Patients

powered by healthline

Average Ratings

Can be given faster than plasma

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 products.

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.

More information

To learn more about this approval, visit the FDA.


-- Scott Roberts
Health News Copyright © 2013 HealthDay. All rights reserved.
Article from
Top of page
General Drug Tools
General Drug Tools view all tools
Tools for
Healthy Living
Tools for Healthy Living view all tools
Search Tools
Search Tools view all tools
Insurance Plan Tools
Insurance Plan Tools view all tools

What is a reference number?

When you register on this site, you are assigned a reference number. This number contains your profile information and helps UnitedHealthcare identify you when you come back to the site.

If you searched for a plan on this site in a previous session, you might already have a reference number. This number will contain any information you saved about plans and prescription drugs. To use that reference number, click on the "Change or view saved information" link below.

You can retrieve information from previous visits to this site, such as saved drug lists and Plan Selector information.