August 26, 2016 -- FDA -- As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.

“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”

The FDA first issued guidance on Feb. 16 recommending that only areas with active Zika virus transmission screen donated Whole Blood and blood components for Zika virus, use pathogen-reduction devices, or halt blood collection and obtain Whole Blood and blood components from areas of the U.S. without active virus transmission. All areas with active transmission in the U.S. are currently in compliance with this guidance. The revised guidance announced today recommends that all states and U.S. territories screen individual units of donated Whole Blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug (IND) application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products.

The FDA is updating its guidance after careful consideration of all available scientific evidence, consultation with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy. Testing of donated blood is already underway in Florida and Puerto Rico, as well as in other areas, and it has shown to be beneficial in identifying donations infected with Zika virus. Expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced.

Zika virus is transmitted primarily by the Aedes mosquito. Zika virus can also be spread by sexual contact. Although 4 out of 5 people infected with Zika virus never develop symptoms, when symptoms do occur they may include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps), and conjunctivitis (red, irritated eyes). In addition, Zika virus infection during pregnancy can cause serious birth defects and is associated with other adverse pregnancy outcomes.

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