Regulatory Focus™ > News Articles > Blood Product Guidance Amended to Reflect New Disease Transmission Risks

Blood Product Guidance Amended to Reflect New Disease Transmission Risks

Posted 13 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released new guidance detailing how sponsors should include additional warnings on their products to reduce the risk of the transmission of Creutzfeldt-Jakob Disease (CJD).

FDA last released a guidance on the topic in 2010, which made recommendations for labeling plasma-derived products to reflect the risks of CJD, which is a form of transmissible spongiform encephalopathy (TSE) spread through prions.  In its 11 June Federal Register notice, FDA said it is calling the labeling to be updated to reflect their understanding that CJD is can be transmitted through the transfusion of blood, and most likely through the transfusion of a plasma derivative.

While the risk of transmission through plasma-derived products is small, FDA said the risk "could not be ruled out," and provided three warnings it said manufacturers should place on the product's safety labeling:

Plasma-derived products Other than Albumin

"Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent."

Plasma-derived Albumin

"Albumin is a derivative of human blood.  Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD).  There is a theoretical risk for transmission of CreutzfeldtJakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote.  No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin."

Products Containing Plasma-derived Albumin

"This product contains albumin, a derivative of human blood.  Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD).  There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote.  No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products."


Read more:

FDA - Draft Guidance for Industry:  Amendment to "Guidance for Industry:  Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant CreutzfeldtJakob Disease by Blood and Blood Products" 

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