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FDA Approves Revised Alphanate® Labeling To Include Reduced Infectivity Of An Experimental Model Agent For VCJD

Alphanate® is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.  Anaphylaxis and severe hypersensitivity reactions are possible.  Development of activity-neutralizing antibodies has been detected in patients receiving FVIII containing products.  Development of alloantibodies to VWF in Type 3 VWD patients has been occasionally reported in the literature.   Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWD patients, especially in the setting of known risk factors.  Intravascular hemolysis may be associated with infusion of massive doses of AHF/VWF Complex (Human).  Rapid administration (>10mL/minute) of a FVIII concentrate may result in vasomotor reactions.  The most frequent adverse events reported with Alphanate® in > 5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain and fatigue.

Because Alphanate is made from pooled human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent. Stringent procedures designed to reduce the risk of adventitious  agent transmission have been employed in the manufacture of this product, from the screening of plasma donors and the collection and testing of plasma, through the application of viral elimination/reduction steps such as solvent detergent and heat treatment in the manufacturing process. Despite these measures, such products can still potentially transmit disease; therefore, the risk of infectious agents cannot be totally eliminated.

About Grifols

Grifols is a global healthcare company founded in 1940 in Barcelona, Spain. Today Grifols' products and services are provided in more than 90 countries around the world. Grifols specializes in the production of plasma therapies to treat a variety of life-threatening diseases and conditions. Grifols operates 80 plasma donor centers throughout the US and has manufacturing facilities located in Barcelona, Spain and Los Angeles, California. For more information about Grifols, please visit www.grifols.com.

SOURCE Grifols

Copyright 2011 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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