A drug for acute major bleeding, called Kcentra (Prothrombin Complex Concentrate, Human) has just been approved by the U.S. Food and Drug Administration.

Kcentra, manufactured by CSL Behring, Marburg, Germany, works as an urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults. The only other product that’s currently approved for the same purpose is plasma.

Plasma improves survival among patients who suffer from massive blood loss as it has the ability to restore the “endothelial glycocalyx,” a special layer lining the blood vessels, according to a previous issue of Anesthesia & Analgesia, the official journal of the International Anesthesia Research Society (IARS).

Sometimes people develop acute bleeding as a result of chronic anticoagulation therapy with medications such as warfarin and other VKA anticoagulants which are used to prevent blood clotting.

Kcentra is administered along with vitamin K, as a measure to reverse the anticoagulation effect and prevent further bleeding. The advantage of Kcentra is that, unlike plasma, it does not require thawing or blood group typing.

Karen Midthun, M.D., director, Center for Biologics Evaluation and Research, FDA, added:

“The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation. Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation.”

There is a risk of blood clots associated with the use of Kcentra, in fact, the medication’s box carries a warning stating that. In addition, the warning says that people on Kcentra should watch out for thromboembolic events, because there have been several reported cases of both fatal and non-fatal arterial and venous thromboembolic complications in clinical trials.

The drug is made from the plasma of health donors and is made in a special way to prevent the transmission of diseases.

The approval decision by the FDA was based on the results of a study which included a total of 216 patients who suffered from acute major bleeding as a result of receiving VKA anticoagulation. The drug proved to be particularly effective at preventing major bleeding.

Written by Joseph Nordqvist