Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA’s Zika Virus Blood Transmission Recommendation
FDA website; 2016 Feb 16; news release
The US Food and Drug Administration (FDA) has issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection. FDA is also recommending that blood establishments defer blood donations from individuals in accordance with the new guidance. Recommendations include:
• In areas without active Zika virus transmission, FDA recommends that donors at risk for Zika virus infection be deferred for four weeks. Individuals considered to be at risk include: those who have had symptoms suggestive of Zika virus infection during the past 4 weeks, those who have had sexual contact with a person who has traveled to, or resided in, an area with active Zika virus transmission during the prior 3 months, and those who have traveled to areas with active transmission of Zika virus during the past 4 weeks.
• In areas with active Zika virus transmission, FDA recommends that whole blood and blood components for transfusion be obtained from areas of the US without active transmission. Blood establishments may continue collecting and preparing platelets and plasma if an FDA-approved, pathogen-reduction device is used. The guidance also recommends blood establishments update donor education materials with information about Zika virus signs and symptoms and ask potentially affected donors to refrain from giving blood.
Citation: US Food and Drug Administration. FDA issues recommendations to reduce the risk for Zika virus blood transmission in the United States. FDA Web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm486359.htm. Accessed February 23, 2016.
1.) US Food and Drug Administration. Zika virus response updates from FDA. http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMIssues/ucm485199.htm#about
