After the death of a preterm baby who was given a probiotic in a hospital, the US Food and Drug Administration is warning hospitals about using probiotics in infants born prematurely.
In a warning letter Friday, the federal agency cautioned health care providers that bacteria and fungi found in probiotics might put preterm infants at risk of “invasive, potentially fatal” infections. The letter references the case of an infant who received the probiotic Evivo with MCT Oil. The product, which is manufactured by Infinant Health for use in hospital settings, contains the infantis subspecies of the live bacterium Bifidobacterium longum.
The baby died after developing sepsis caused by the same species of bacteria, the letter said.
“Genomic sequencing data demonstrate the bacterium that caused sepsis in this infant was a genetic match to the bacteria contained in this probiotic,” the FDA’s letter said.
Probiotics, which contain live bacteria or other microorganisms for health benefits, are commonly used in the United States as dietary supplements. Since they’re considered dietary supplements, they are not subject to the FDA approval process.
According to the American Academy of Pediatrics, about 10% of preterm infants receive probiotics while in neonatal ICUs, a number that’s steadily increasing across the country.
The group’s most recent guidelines also don’t recommend the supplements for preterm infants.
“Given the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of <1000 g,” according to a 2021 clinical report from the pediatrician group.
The FDA’s letter points out that the agency has not approved any probiotic product for use in infants. In September, it released a public warning to Infinant Health in which it described Evivo with MCT Oil as “an unapproved new drug and unlicensed biological product.”
The company’s marketing of the probiotic as a drug treatment violated several components of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, the warning says.
In a statement, Infinant Health said it has agreed to recall Evivo with MCT Oil and notified health care providers and hospitals.
“We are cooperating with FDA’s ongoing investigation” into the infant’s death, the company says.
Its Evivo powder, which is available to consumers, is not subject to an investigation or recall, Infinant noted.
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Recent research suggests that probiotics might be a useful treatment option for preterm infants.
A review of 106 trials including nearly 26,000 infants, published Monday in the journal JAMA Pediatrics, found that probiotics with multiple strains of bacteria helped reduce overall infant death, feeding intolerance and a life-threatening inflammation of the intestines in infants called necrotizing enterocolitis.
Unlike those products, however, Evivo with MCT Oil contains only a single strain of bacteria.
CNN’s Katherine Dillinger contributed to this report.