FDA Warns of Risks from Probiotics in Hospitalized Premature Infants Following Death and Adverse Events

FDA flags probiotics as unapproved drugs following link to adverse events and death in preterm infants; company Abbott Laboratories has agreed to discontinue its implicated Similac Probiotic Tri-Blend product while debate intensifies over the use of probiotics in neonatal care.

• The US FDA has issued a warning about the risks of using probiotics in hospitalized premature infants, as the products have been linked to over two dozen adverse events and one death since 2018. The warning targets the use of such products in treating necrotizing enterocolitis, a life-threatening inflammation of the intestines, which affects up to 1 in 20 premature infants.
• Abbott Laboratories agreed to discontinue its Similac Probiotic Tri-Blend product, which the FDA considered an unapproved new drug and unlicensed biological product. The issue is linked to a single probiotic additive, used in less than 200 hospitals, and does not apply to other Abbott infant formula products.
• The FDA also revealed that an infant died after receiving the probiotic Evivo with MCT Oil from Infinant Health, which contained the infantis subspecies of the bacteria Bifidobacterium longum, known to possibly cause sepsis in infants. The product has since been recalled and is no longer available in the US.
• The FDA called for further high-quality clinical trials to provide definitive evidence about the safety and effectiveness of probiotics in preventing necrotizing enterocolitis, as current data is conflicting. Neither the FDA or the American Academy of Pediatrics approve the use of probiotic supplements for premature infants.
• While some physicians continue to support the use of probiotics, arguing that they help rebuild the gut microbiome and can prevent infections, the FDA stresses that any probiotic products used for the prevention or treatment of disease have not undergone the agency’s rigorous premarket process for safety, efficacy and quality.

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