FDA Issues Warning to Hospitals Regarding Probiotics for Premature Babies Following Infant's Tragic Death

The US Food and Drug Administration (FDA) has issued a warning to hospitals about the use of probiotics in premature infants following the death of a preterm baby who was given a probiotic in a hospital. The FDA cautioned that bacteria and fungi found in probiotics may pose a risk of "invasive, potentially fatal" infections in preterm infants. The warning letter referenced a case where an infant died after developing sepsis caused by the same species of bacteria found in the probiotic. The FDA has not approved any probiotic product for use in infants, and the American Academy of Pediatrics does not recommend their routine administration to preterm infants. Infinant Health, the manufacturer of the probiotic involved in the case, has agreed to recall the product and is cooperating with the FDA's investigation.