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Medical Advisory #401: vCJD Risk Announced for U.K. Plasma Products

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Medical Advisory #401: vCJD Risk Announced for U.K. Plasma Products

October 14, 2004

On September 21, 2004, United Kingdom (UK) health authorities informed people with hemophilia and other bleeding disorders that they are considered "at risk" for variant Creutzfeldt-Jakob Disease (vCJD) if they used UK plasma products manufactured between 1980 and 1998. These products were made from plasma collected from donors in the UK who were later identified to have vCJD or possibly from donors who still remain asymptomatic for vCJD.

The UK's products were manufactured by Bio Products Laboratory and Protein Fractionation Centre, Scotland. These companies were not licensed by the US Food and Drug Administration (FDA) to distribute products in the United States, but UK plasma products, particularly factor XI, may have been brought into the US for use in clinical trials or for compassionate or personal use. FDA has not approved any manufacturing claim that the production process for any plasma-based coagulation product eliminates the risk of vCJD
transmission. However, to date, no cases of vCJD are known to have been transmitted by any plasma product. The UK health
authorities have said their actions are "precautionary" and "the actual risk to individuals is very low."

NHF is seeking to determine if any US clinical studies utilized UK plasma products. Anyone who suspects they may have used a UK plasma product between 1980 and 2001 or anyone who lived or visited the UK during 1980 to 2001 and used UK plasma products during that time should contact their hemophilia treatment center. (The last year that the U.K. implicated product was produced was 1998, but the risk extends to the 2001 expiration date for these products.) UK plasma products manufactured after 1998 did not use plasma collected from UK donors.

The NHF will disseminate updated information concerning this issue as it becomes available. Additional information can be found through the following sites:

Canadian Hemophilia Society -
http://www.hemophilia.ca/en/index.html

U.K. Haemophilia Society –
http://www.haemophilia.org.uk/news.php?id=16

PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.

CHAPTERS: Please distribute this information to your membership.

Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The System is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge.

To enroll in the PNS, please call (888) UPDATE-U or go online at
http://gomembers-ecommunicator.com/ct/sdqj1Up1_1Nv/Patient-Notification-System.

This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.