In the past two months, French authorities have announced the discovery of two blood donors who were diagnosed with variant Creutzfeldt-Jakob disease (vCJD) . Recipients of blood and platelets from these two donors are being notified and tracked by health authorities in France. Although implicated in-date plasma products have been recalled by the manufacturer, recipients of plasma-derived products made with plasma from these donors are not being notified.
On October 21 the French health ministry announced that a blood donor, who is still alive, has developed vCJD. The individual donated blood “several times” between 1993 and 2003. Ten people who received transfusions of red blood cells are being tracked. LFB, the French manufacturer of plasma derivatives including clotting factor concentrates, has issued a recall of in-date products made with the donor's plasma, including Factane (factor VIII), Clottagen (fibrinogen), Facteur Willebrand and Factor XI. LFB has informed several countries that they have not received implicated batches, however, neither LFB nor the French authorities has released a complete list of expired implicated batches or importing countries to the World Federation of Hemophilia (WFH).
On November 23, the French authorities announced an additional discovery of blood donations by an individual later diagnosed with vCJD. This person - the ninth French case of vCJD – is reported to have donated blood several times between 1984 and 2002. Again, recipients of blood and platelet transfusions are being notified through their doctors of their potential exposure to vCJD, however, detailed information has not been released as to exposures to plasma derivatives.
“As for the blood derivation products, the transmission risk has not been established. If it does exist, it is in any case reduced by the various stages in the manufacturing process,” the health ministry said.
Agence Française de sécurité sanitaire des produits de santé
Santé - Protection sociale
In addition, patients in Belgium have been informed that the Belgian Red Cross used French-sourced plasma, from one of these donors who subsequently developed vCJD, to produce factor VIII and IX in 1995 and 2002. L’Association de l’Hémophilie (AHVH)
Although transmission of vCJD with blood and blood components such as cells or plasma is not accepted as highly probable, the risk of transmission of vCJD by plasma-derived products still remains theoretical since there is no known case of transmission of vCJD by plasma products and no person with hemophilia has been diagnosed with vCJD.
It is our understanding that LFB has notified the national regulatory authorities and their own distributors in the countries that imported the implicated products. This information has not been made available to the WFH. National Member Organizations of the WFH that know of use of LFB products in their countries should contact the manufacturer’s representatives or the French health authorities concerning information on whether lots of clotting factor manufactured from donations produced by these donors were used in their countries.
The WFH continues to closely monitorvCJD risk in French and U.K.-sourced plasma products and will keep the hemophilia community informed as new developments emerge. The WFH TSE Task Force has released “variant Creutzfeldt-Jakob disease and Hemophilia - Further guidance on assessing the risks of plasma-derived products for treating hemophilia,” prepared by Dr. Albert Farrugia, on behalf of the TSE Task Force.
Last Updated: December 14, 2004
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