FDA STATEMENT ON BLOOD INDUSTRY'S VOLUNTARY MARKET WITHDRAWAL OF CERTAIN FROZEN BLOOD PRODUCTS TO REDUCE RISK OF WEST NILE VIRUS TRANSMISSION FROM TRANSFUSION

The Food and Drug Administration (FDA) has been working with the Centers for Disease Control and Prevention (CDC) and the blood banking community to assess and manage the potential risk of West Nile Virus transmission from blood and blood products.

A small number of cases of West Nile Virus infection have been linked to the receipt of blood products that carried the virus. The estimated risk to recipients of blood and blood products is thought to be low; but it varies by region and time period of the epidemic.

In October 2002, FDA issued a final guidance document that provided recommendations for the assessment of donor suitability and blood and blood product safety in cases of known or suspected West Nile Virus infection (www.fda.gov/cber/gdlns/wnvguid.htm).

Although the risk from an individual unit of blood or plasma collected and frozen during the epidemic is likely to be low, FDA believes that the voluntary withdrawal of certain frozen products is a rational response to the risk at this time.

FDA will continue to review its recommendations as we learn more about the epidemic. As in many situations involving potential risks from blood products, it is important to weigh the public health benefits of possible interventions to ensure that an adequate supply of blood products is available. FDA is pledged to working with CDC and the blood banking community to help ensure that safe products will be available wherever they are needed.

FDA will provide updates to this situation as new information becomes available.

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