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vCJD Risk Information Available on New FDA Web Page
 

On March 15, 2007, the Food and Drug Administration (FDA) launched a new Web page
containing a series of informative fact sheets and other documents relating to the
potential risk of variant Creutzfeld-Jakob Disease (vCJD), a human form of mad cow
disease, for people with bleeding disorders who have used plasma-derived factor
products. The documents include the agency’s recently released risk assessment for users
of US-licensed plasma-derived factor VIII products (pdFVIII), as reported in NHF’s
Medical Advisory #406. The assessment confirmed that there are still too many
uncertainties to allow the FDA to make a precise calculation of theoretical risk, and that
the risk is likely to be exceedingly low but possibly not zero.

The new Web page is part of a communication strategy the FDA devised with input from
the bleeding disorders community, including representatives of the National Hemophilia
Foundation (NHF), the Committee of Ten Thousand (COTT) and the Hemophilia
Federation of America (HFA). The documents on the site include a report on the risk
assessment, guidance on blood donor deferral, and “questions and answers” on key
aspects of the issue.

To access the new FDA Web page, go to: http://www.fda.gov/cber/blood/vcjdrisk.htm

To read NHF Medical Advisory #406, go to: http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=116&contentid=713&rptname=news

For information on blood and product safety issues, go to NHF’s Web site:
www.hemophilia.org.