The FDA is proposing a warning to cover the “extremely remote risk” of viral disease spreading from drugs manufactured using albumin.
Proposed additions to the warning labels come two years after the US Food and Drug Administration (FDA) posted guidance on the spread of variant Creutzfeldt-Jakob disease (vCJD). The 2010 guidance added labelling requirements to blood for transfusion but the FDA now plans to extend the warning .
If the broader interpretation comes into force labels of products containing plasma-derived albumin will feature the following warning: “Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and vCJD.”
The labelling change would impact some vaccines and recombinant clotting factor products. Certain licensed vaccines are manufactured using culture media that contains albumin, while recombinant clotting factor products can use it as a stabiliser.
While there is no epidemiological evidence for transmission of vCJD by products containing plasma-derived albumin the FDA is taking a cautious approach. The FDA said its recommendations “reflect the extremely low likelihood of vCJD and CJD transmission through these products”.
A similar warning is proposed for plasma-derived albumin. “There is a theoretical risk for transmission of CJD, but if that risk actually exists, the risk of transmission would also be considered extremely remote”, the FDA wrote in its draft amendment.
The strongest new warning label is used on plasma-derived products other than albumin. “Because this product is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the vCJD agent and, theoretically, the CJD agent”, the FDA wrote.
A comment period began this week and stays open until September 10.