Volume 7, Number 4
Recall of Mononine component pack
CSL Behring has reported that some Mononine (factor IX) component packs (including transfer needles, butterfly needles) did not have a complete seal between the soft blister pack and the package cover. Neither the Mononine vial nor the sterile water vial is affected, only the component packs. CSL Behring will ship sufficient replacement component packs direct to consumers.
http://www.fda.gov/
Final report on outbreak of adverse reactions associated with contaminated heparin
The US Centers for Disease Control and Prevention reports that a total of 152 adverse reactions associated with heparin occurred in the US between November 19, 2007 and January 31, 2008. The use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with the reactions. Vials of heparin manufactured by Baxter from facilities that reported reactions contained a contaminant identified as oversulfated chondroitin sulfate (OSCS). Adverse reactions to the OSCS-contaminated heparin were often characterized by hypotension, nausea, and shortness of breath occurring within 30 minutes after administration. None of these adverse reactions involved clotting factor concentrates. http://content.nejm.org
Green Cross recombinant FVIII product approved
The Korea Food and Drug Administration has approved the marketing of GreenGene, a coagulation factor VIII product developed using recombinant technology. http://eng.greencross.com/ (news release dated 2008.09.09)
Manufacturer chosen for new recombinant FVIIa product
Avid Bioservices will manufacture clinical-grade material for Catalyst Biosciences to support development of its version of factor VIIa for the treatment of acute bleeding in hemophilia patients with inhibitors. The product, CB 813, is currently in preclinical development. http://www.avidbio.com/
Orphan drug approval for new recombinant FIX product
Biovitrum's and Syntonix's Novel Factor IX product has received orphan drug designation from the FDA. Besides securing a period of market exclusivity for the drug once it is approved, orphan designation will mean reduced marketing application and license fees and the ability to work with the Office of Orphan Drugs and the Division of Blood Applications. http://www.biovitrum.com
Scottish government backs MSM blood donor ban
The Scottish National Blood Transfusion Service has rejected calls to lift the ban on men who have sex with men donating blood. It has told the Scottish Parliament petitions committee that HIV infection is rising in gay men and donor selection is one of the measures required to keep blood products safe.
http://news.bbc.co.uk/
Researchers use bone-marrow transplant to treat hemophilia
In the October 2008 edition of Blood, researchers describe how a gene-modified bone marrow transplant may be used to initiate clotting in hemophilia. In the experiment in mice the bone marrow is removed from the patient and stem cells are treated with factor VIII, which is placed in the platelets. The marrow is given back to the patient, who then retains the essential clotting mechanisms. This type of approach may work in patients who have developed inhibitors. http://bloodjournal.hematologylibrary
Statement by European Commission on the difference between plasma-derived medicinal products and whole blood and blood components
The European Commission has stated: “In preparation to the forthcoming second report on the promotion by the Member States of voluntary unpaid donations, the Commission will pay due regard to the different blood components collection procedures when considering the interpretation and implementation of the principle of voluntary unpaid blood donations in the European context.” The concern for people with bleeding disorders in Europe is that unpaid donations are not sufficient to supply the needed treatment products. Clotting factor concentrates (CFCs) made from paid donations have had an excellent safety record for the last 15 years and since the global supply of CFCs is so tight, any restriction on access to these products would have immediate serious consequences for patients. Following a meeting in May of this year with Commissioner Vassiliou, the commission has agreed to proactively involve the coalition of organizations representing the most frequent users of plasma products (including WFH and European Haemophilia Consortium) in their deliberations. http://www.europarl.europa.eu/
Events
International Plasma Protein Congress 2009 (IPPC)
3-4 March 2009 – Paris, France
Internet: http://www.IPPC2009.com
Plasma Protein Forum 2009
2-3 June 2009 – Washington, D.C., USA.
Internet: http://www.plasmaproteinforum.com
6th IABs Symposium on Advances in Transfusion Safety
6-7 July 2009 – University of Cambridge, United Kingdom
Internet: http://www.haem.cam
XXII ISTH Congress
11-17 July 2009 – Boston MA, USA
Internet: http://www.isth2009.com
Global Forum 2009
24-25 September 2009 – Montreal, Canada
Internet: http://www.wfh.org
Safety & Supply News
Published bi-monthly by the World Federation of Hemophilia.
Next issue: April 2009
Editorial Board: Claudia Black, WFH (Canada); Albert Farrugia, PhD (Australia); 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); Alison Street, MD (Australia)
Editor: Mark Brooker, WFH World Federation of Hemophilia
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Montréal, Québec H3G 1T7 Canada
Tel.: +1 (514) 875-7944 Fax: +1 (514) 875-8916
E-mail: wfh@wfh.org
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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.
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