Anticoagulation Update: New Agent for Urgent Anticoagulation Reversal, Pradaxa Label Revised

April 30th, 2013

Anticoagulation Update: New Agent for Urgent Anticoagulation Reversal, Pradaxa Label Revised

Larry Husten, PHD

Here are two small but important changes in the anticoagulation field:

FDA approves new product for urgent reversal of anticoagulation. The FDA yesterday approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Unlike plasma, which is currently the only available method to reverse anticoagulation, the new product does not require blood group typing and does not need to be thawed, so it can be quickly delivered to patients, the FDA said. Kcentra is manufactured by CSL Behring.

The Kcentra label will include a boxed warning about the risk of blood clots. The FDA says that patients who take Kcentra “should be monitored for signs and symptoms of thromboembolic events, as both fatal and non-fatal arterial and venous thromboembolic complications have been reported in clinical trials and post marketing surveillance.”

The FDA said that Kcentra is derived from the pooled plasma of healthy donors and is processed “in a way to minimize the risk of transmitting viral and other diseases.”

Pradaxa label gains boxed warning. The label for dabigatran (Pradaxa, Boehringer Ingelheim) will now contain a boxed warning advising patients that discontinuing treatment increases the risk of stroke. Previously the label contained similar information but it had not been highlighted. The Pradaxa label also now includes thrombocytopenia in the postmarketing experience section and includes more details from the pivotal RE-LY trial.

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April 30th, 2013