WASHINGTON – The Food and Drug Administration issued a guidance Friday that recommends universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
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.
“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, M.D., the FDA’s acting chief scientist. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”
A similar guidance was issued in February that recommended that only areas with active Zika virus transmission screen donated Whole Blood and blood components for Zika virus.
The revised guidance recommends all states and U.S. territories screen individual units of donated blood with a blood screening test authorized for use by the FDA under an investigational new drug application or a licensed test.
Zika virus is transmitted primarily by the Aedes mosquito and 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.
As of August 24, there were more than 11,500 confirmed cases of Zika virus in the U.S. states and territories — 2,517 in U.S. states and Washington D.C. and 9,011 in U.S. territories.