FDA Issues Important Information Regarding Oropouche Virus and Blood Donation

The Centers for Disease Control and Prevention recently reported cases of Oropouche virus (OROV) infection in Americans who have returned from areas experiencing outbreaks, including Cuba. A new safety and availability communication release by the Food and Drug Administration on Friday provides important information for blood establishments regarding OROV and blood donation. There are no reports of transmission of OROV in the United States and the number of cases among American travelers remains low.

Although a screening test for OROV is not currently available, FDA reiterated for the blood community that there have been no reported cases of transfusion-transmitted OROV anywhere in the world. FDA added that blood donors must be in good health on the day of donation and that routine measures used to screen blood donors for infectious diseases remain effective. No additional safeguards – including asking specific questions about exposure to OROV or travel to areas with OROV outbreaks – are warranted at this time. The responsible physician “may wish to consider a short deferral (e.g., 4 weeks) if a donor volunteers that they were recently diagnosed with or have recovered from OROV disease.” 

In its communication, FDA referenced AABB’s recently published fact sheet on OROV.

AABB will continue to monitor the situation and will update the blood community as needed. Those with questions are invited to contact regulatory@aabb.org.