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FDA Committee Discusses Emerging Blood Supply Threats

On December 15-16, 2010, the U.S. Food and Drug Administration's (FDA) Blood Products Advisory Committee (BPAC) met to discuss policies and procedures for guarding the nation's blood supply against emerging diseases.  The committee examined current research and data on dengue viruses and murine leukemia viruses (MLV) to determine if preventive action is needed. 

First, the committee was asked whether safety interventions were warranted to address the risk of transfusion transmission of dengue viruses in the U.S., and if blood donors should be deferred if they have traveled to an endemic area.  Dengue fever is a mosquito-borne disease that is common in tropical regions, but rare in most of the U.S.  For blood donors from areas where the virus is more common, such as South Florida, Puerto Rico, and territories in the Caribbean and Pacific, the committee voted that intervention was warranted.  BPAC members suggested specific questions on the donor questionnaire regarding medical history and the use of selective testing.  The committee further voted that the data did not support a deferral for donors living in nonendemic areas who traveled to endemic areas.

The FDA next sought BPAC's advice on establishing a donor deferral policy for donors with a history of chronic fatigue syndrome (CFS).  CFS has been linked to the presence of murine leukemia viruses. Because MLVs are found in the blood, there is a theoretical possibility of transmission through blood transfusion.  However, the virus has not been shown to cause the syndrome, and there is no direct evidence of transfusion transmission.  Nonetheless, the panel voted that the FDA should require a screening question to ask potential donors if they have a medical history of CFS, and to defer indefinitely if they do.  BPAC acknowledged the risk CFS donors posed to the blood supply and chose to prevent donations until more information becomes available. 

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