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March 28th, 2003 Usage of Solvent Detergent (S/D) treated plasma in Liver Transplantation Various statements have been published in relation to the use of the product Plas+SD in the US in connection with liver transplants. A recent study has reported an increased incidence of hyperfibrinolysis in liver transplant patients after introduction of S/D treated plasma (1) Clinical data to date, with Octaplas in liver surgery, has shown no serious side- effects reported by the investigators (2,3) Octapharma's SD virus inactivated Octaplas is distinctively different from Plas+SD, both in terms of manufacturing and final composition (3-9) Octapharma has nevertheless taken pro-active steps to negotiate with the licensing authorities in Europe to amend the Summary of Product Characteristics to include the following statement: "Octaplas should not be used to correct hyperfibrinolysis caused by plasmin inhibitor (PI) deficiency as dilution with S/D treated plasma will further reduce PI levels. If necessary, appropriate antifibrinolytic treatment should be initiated." References 1. Jonge de J et al. Anesth Analg 2002;94: 1127-31 2. Freeman JW et al. Vox Sang 1998;74: Suppl.1: 225-229 3. Williamson LM, et al. Transfusion 1999;39: 1227-1234 4. Beeck H, Hellstern P, Vox Sang 1998;74, Suppl.1:219-223 5. Mast AE. et al. Blood;1999;94;11 3922-3927 6. Bianco C. Transfusion Medicine Reviews 1999;13,2: 84-88 7. Klein HG et al. Transfusion 1998; 38:102-107 8. Leebeck FWG et al. Transfusion; 39. Oct 1999 9. Morfeld F et al. Pharm. Ind; 58, 433-435 © Octapharma AG, 2003 |