The US Food & Drug Administration (FDA) has issued a general warning and a specific warning letter about the use of probiotics for pre-term infants, with some products having been linked to more than two dozen reported “adverse events” since 2018 and one death in 2023, the agency said.
Probiotics – containing live bacteria or other micro-organisms – are often used as dietary supplements, which are not subject to the FDA’s approval process.
The agency said there was “conflicting data” about safety and effectiveness of probiotics for prevention of necrotising enterocolitis, reports Food Safety News.
“Adverse events in any infant after a probiotic are a concern …We especially want to make clear that products containing live micro-organisms may present serious risks to preterm infants in hospital settings,” said Dr Peter Marks, director of the FDA’s Centre for Biologics Evaluation and Research.
Recently, an infant died after being given the probiotic Evivo with MCT Oil, a product manufactured by Infinant Health for use in hospital settings, and which contained the infantis subspecies of the live bacterium Bifidobacterium longum.
The baby died after developing sepsis caused by the same species of bacteria.
The FDA said it hasn’t approved any probiotic products for infants of any age, and products haven’t been evaluated for safety, effectiveness or compliance with manufacturing and testing standards.
Warning to Similac
Last week, the FDA sent a warning letter to Abbott Laboratories for its Similac Probiotic Tri-Blend product, which the agency describes as an unapproved new drug and unlicensed biological product based on statements on its website and in marketing materials.
The company agreed to discontinue sales of the product, the FDA said.
See more from MedicalBrief archives:
Targeting gut microbiota to successfully treat infant colic
Probiotics may halve gut problems and infections in very premature babies
Most baby formula health claims not science-backed – global analysis