In recent years, questions have been raised concerning the potential risk of variant Creutzfeldt-Jakob disease (vCJD - a rare but fatal brain infection) for recipients of plasma- derived clotting factors, including United States (US) licensed Factor Eight (pdFVIII), Factor Nine (pdFIX), and other plasma-derived products such as immune globulins and albumin. In response to these questions, FDA conducted a risk assessment. Based on the risk assessment, the US Public Health Service (PHS) believes that the risk of vCJD to patients who receive US licensed pdFVIII products is most likely to be extremely small, although we do not know the risk with certainty. vCJD risk from other plasma derived products, including Factor IX, is likely to be as small or smaller.
Additionally, the potential risk of vCJD infection from an investigational (non-US licensed) plasma-derived Factor Eleven (pdFXI) product that was made using plasma from donors in the United Kingdom (UK), and studied under IND in the US between 1989 and 2000 in a small number of subjects, has also been raised. Based on a risk assessment for this product and additional considerations, PHS believes the potential vCJD risk from this investigational pdFXI product is likely to be small.
This web page provides FDA's risk assessments for US licensed pdFVIII and the investigational pdFXI product, and risk communication materials for these products and other plasma derivatives. Included are Key Points, and Questions and Answers. Additional links are provided to FDA's current guidance documents on deferral of blood and plasma donors who may be at increased risk of vCJD, and to other sources of information regarding vCJD.
Other Sources of Information
- Blood Products Advisory Committee Meeting - Summary of Recent TSEAC Meeting and Statement about FXI from the UK, on October 21, 2004
- Information on vCJD: Centers for Disease Control and Prevention
- Information on Bovine Spongiform Encephalopathy ("Mad Cow Disease"): US Department of Agriculture
- Committee of Ten Thousand
- Hemophilia Federation of America
- National Hemophilia Foundation and/or HANDI
- World Federation of Hemophilia
Documents Regarding US Licensed pdFVIII, and Other US Licensed Plasma Derivatives Including pdFIX
Potential vCJD Risk From US Licensed Plasma-Derived Factor VIII (pdFVIII, Antihemophilic Factor) Products: Summary Information, Key Points Risk Assessment(PDF - 590KB) Risk Assessment Appendix(PDF - 622KB) Variant Creutzfeldt-Jakob Disease (vCJD) and Factor VIII (pdFVIII) Questions and Answers Variant Creutzfeldt-Jakob Disease (vCJD) and Plasma Derivatives Other than Factor VIII (pdFVIII) Questions and Answers
Documents Regarding Investigational pdFXI from Donors in the UK
FDA Draft Risk Assessment: Potential Exposure to the variant Creutzfeldt-Jakob Disease Agent in United States Recipients of Factor XI Coagulation Product Manufactured in the United Kingdom(PDF - 407KB) Potential Variant Creutzfeldt-Jakob Disease (vCJD) Risk From Investigational Factor Eleven (pdFXI) From Donors in the United Kingdom: Summary Information, Key Points[ARCHIVED] Variant Creutzfeldt-Jakob Disease (vCJD) and Factor XI (pdFXI) Questions and Answers
Guidance on Donor Deferral Related to CJD and vCJD
Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products"[ARCHIVED] 8/8/2006 Questions and Answers on FDA Guidance: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob (CJD) Disease and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products[ARCHIVED] 1/22/2004 Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products 1/2002