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APRIL 2008 - VOL 7, NO 2 The WFH Safety & Supply News is an electronic newsletter on the safety, supply, and availability of hemophilia treatment products. The publication provides reliable, timely summaries of news and new developments in products, viral safety, and gene therapy. You can also view Safety & Supply News online . Contaminated heparin The US Food and Drug Administration (FDA) has identified oversulphated chondroitin sulphate as the contaminant in the blood thinner heparin which has been recalled after being associated with adverse events in several countries. The adverse events have included allergic or hypersensitivity-type reactions, with symptoms such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain. Heparin is used in the manufacture of some clotting factor concentrates, however the heparin associated with the adverse events contained very high doses of the contaminant. It is highly unlikely that this contamination problem will have any effect on hemophilia treatment products. To date there have been no reports of any adverse events in hemophilia patients. The WFH is watching closely and communicating with regulatory authorities. http://www.fda.gov http://content.nejm.org/cgi   Two new vCJD cases inSpain The second and third cases of variant Creutzfedlt Jakob disease (vCJD) have recently been identified in Spain. A man and a woman, both fitting the genetic profile of the majority of vCJD cases, died in the past 2 years. No clear specific dietary habits, blood donations or transfusions were recorded. Neither case appears to have visited the United Kingdom before 2004. http://www.eurosurveillance.org   First atomic-level look at prions Researchers at Ohio State have used solid-state nuclear magnetic resonance (NMR) spectroscopy to study the prion molecule at the atomic level for the first time. Prions are the infectious agent implicated in vCJD. http://www.sciencedaily.com   Scottish blood inquiry launched The Scottish government has launched a public inquiry into how people were infected with hepatitis C and HIV through contaminated blood products including clotting factor concentrates. http://www.snp.org   WFH response to International Federation of Blood Donors Organizations In response to a letter from the International Federation of Blood Donors Organizations (IFBDO http://www.fiods.org/), titled “Sufficiency of supply of blood and blood products within the European Union,” the WFH has written to the European Commission clarifying our position on the safety and supply of hemophilia treatment products. Patient organizations for other users of plasma derived medicines have joined the WFH in asking the Commission to consult patients before making decisions on the life-saving medicines these groups rely on. WFH letter to the European Commission (PDF)   Wyeth's new recombinant factor VIII product approved in US In February the FDA approved Wyeth's new recombinant factor VIII product, Xyntha. This product contains no albumin and is purified using no human or animal products. http://www.fda.gov   FDA publishes overview of the regulation of biological products The FDA has posted several documents explaining the regulation of biological products including products for the treatment of bleeding disorders. http://www.fda.gov   Upcoming events The IPFA/PEI 15th Workshop on "Surveillance and Screening of Blood Borne Pathogens" 13-15 May 2008, – Vienna, Austria Email: ipfa@sanquin.nl Internet: http://www.sanquin.nl/ipfa/Upcoming_Events.nsf Hemophilia 2008 World Congress 1-5 June 2008 – Istanbul, Turkey E-mail: hemophilia2008@wfh.org Internet: http://www.hemophilia2008.org 13th Congress of the European Hematology Association 12-15 June 2008 – Copenhagen, Denmark Email: eha@eurocongres.com Internet: http://congress.ehaweb.org Plasma Protein Forum (PPTA) 17-18 June – Washington, D.C., USA E-mail: dkrueger@pptaglobal.org Internet: http://www.plasmaproteinforum.com Bar Coding of Plasma Derivative Products International Council for Commonality in Blood Bank Automation 20 June, 2008 – Toronto, Canada Internet: www.gs1.org 54th Annual SSC Meeting of the ISTH 2-5 July 2008 – Vienna, Austria Email: headquarters@isth.org Internet: http://www.med.unc.edu/isth/SSC2008/   Mark Brooker Senior Public Policy Officer 1425 Ren? L?vesque Blvd. West, Suite 1010 Montr?al, QC, H3G 1T7,  Canada Tel.: +1 (514) 875-7944 Fax: +1 (514) 875-8916 E-mail: mbrooker@wfh.org www.wfh.org Published bi-monthly by the World Federation of Hemophilia. Next issue: June 2008 Editorial Board: Albert Farrugia, PhD (Australia); Claudia Black, WFH (Canada); Paul Giangrande, MD (U.K.); Keith Hoots, MD (U.S.A.); Elizabeth Myles, WFH (Canada); Brian O'Mahony (Ireland); David Page (Canada), Mark Skinner (U.S.A.); Mike Soucie, PhD (U.S.A.); Alok Srivastava, MD (India) Editor: Mark Brooker, WFH To subscribe or unsubscribe to the WFH Safety and Supply News, please send your name and email address to aryan@wfh.org Permission to translate and/or reprint all contents of the Safety and Supply News is granted to interested non-profit hemophilia organizations, with prior approval and appropriate acknowledgment of the WFH. Permission does not extend to reproduction, in whole or in part, for sale or use in conjunction with commercial purposes.