The Food and Drug Administration (FDA) is warning health care providers about the risk of invasive disease in preterm infants administered probiotics.
The warning comes following the death of a preterm infant who was administered Evivo with MCT Oil, a probiotic formulated with live bacterium Bifidobacterium longum subsp. infantis, as part of in-hospital care. Genomic sequencing data confirmed that the bacterium that caused sepsis in the child was a genetic match to the bacteria contained in the probiotic.
Though the FDA is aware that some unlicensed probiotics are being used to treat infants, these products have not been evaluated for safety or effectiveness in this vulnerable population. Administering products with live bacteria or yeast to preterm infants can result in potentially fatal disease. According to a clinical report published by the American Academy of Pediatrics, “current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of less than 1000g.”
Health care providers who administer probiotics containing live bacteria or yeast as a treatment are required to submit an Investigational New Drug Application to the FDA. Adverse events should also be reported to the FDA’s MedWatch Program.
This article originally appeared on MPR
US Food and Drug Administration. Risk of invasive disease in preterm infants given probiotics formulated to contain live bacteria or yeast. Accessed September 29, 2023. https://www.fda.gov/media/172606/download?attachment.