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FDA Warns Against Using Infant Probiotic Products

The U.S. Food and Drug Administration (FDA) has raised concern over the use of probiotics in preterm babies in hospital settings following an infant’s death.

Probiotic products are being illegally sold to treat or prevent diseases in preterm infants in hospital settings, such as to reduce the risk of necrotizing enterocolitis, according to the FDA.

Preterm infants who are administered a probiotic product are at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast contained in the probiotics.


Necrotizing enterocolitis is a life-threatening illness in which tissues in the intestine become inflamed and start to die. The condition is almost exclusively affecting infants less than four weeks old, with a mortality rate as high as 50%.

In September, the FDA sent a letter to healthcare providers describing a case of a preterm infant who died of sepsis caused by the Bifidobacterium longum after being administered a probiotic, Evivo with MCT Oil manufactured by Infinant Health.

The use of probiotics in infants has been associated with more than two dozen other reported adverse events in the United States since 2018, the FDA says.

“Adverse events in any infant following the use of a probiotic are a concern to the FDA. We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

Probiotics are products containing live organisms such as bacteria or yeast and are commonly marketed as foods or dietary supplements. There are no FDA-approved probiotics to use in infants of any age.

Additionally, unapproved, unlicensed probiotics have not undergone the agency’s premarket evaluation for safety and effectiveness.

The FDA issued warning letters to companies selling similar probiotic products intended for infants, Abbott Laboratories, and Infinant Health (formerly Evolve BioSystems Inc.). Both companies voluntarily recalled these products, Reuters reported.

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