EC. Under the auspices of the Committee on Proprietary Medicinal Products, an international workshop on transmissible spongiform encephalopathies was held in January 1998 to consider the available information on new variant Creutzfeldt-Jakob disease (nvCJD) and relevant TSEs. The CPMP reached the following conclusions:
• There is no evidence that sporadic, familial or iatrogenic Creutzfeldt-Jakob disease (CJD) is transmitted via blood transfusion or via plasma-derived medicinal products. Therefore, the CPMP reaffirms its recommendation that recall of plasma-derived products is not justified where a donor is later confirmed as having CJD.
• It is now recognized that nvCJD has different characteristics to sporadic, familial and iatrogenic CJD. Knowledge of other TSE agents suggests that transmission of nvCJD by medicinal products derived from human blood or plasma is very unlikely. Nevertheless, since there is a lack of specific information on nvCJD, the CPMP considers that, as a precautionary measure, it would be prudent to withdraw batches of plasma-derived medicinal products from the market if a donor to a plasma pool is subsequently strongly suspected, by a recognized reference centre, of having nvCJD. However, consequences for essential medicinal products where alternatives are not available will need careful consideration by national authorities.
• Since a recall involving albumin used as an excipient has the potential to cause major supply difficulties for essential products, manufacturers should avoid using, as an excipient, albumin derived from countries where a number of cases of nvCJD have occurred.
Reference: CPMP Position Statement on New Variant CJD and Plasma-derived Medicinal Products, EMEA, 25 February 1998.