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Risks of Probiotics: FDA Issues Warning on Administering Probiotics to Infants Following Tragic Fatality

Photo: CBS News

Food and Drug Administration (FDA) recently disclosed concerns about the risks of probiotics for very young infants.

Risks of Probiotics: FDA Issues Warning on Administering Probiotics to Infants Following Tragic Fatality (Photo: CBS News)

The FDA’s Warning: Risks to Preterm Infants

In  a report featured by NBC News, in October 27, 2023, this revelation comes in the wake of an infant death linked to risks of probiotics earlier this year, prompting an investigation into over two dozen adverse events involving infants since 2018. The FDA has raised questions about the safety and legality of probiotics for infants, highlighting the lack of FDA-approved probiotics for babies and the alarming trend of unregulated use, especially in preterm infants in hospital settings. Probiotics, which contain live bacteria or microorganisms, are widely used as dietary supplements in the United States, but their safety and effectiveness are not reviewed by the FDA due to their supplement classification and lead to some risks of probiotics.

In a recent letter sent to healthcare providers, the FDA emphasized the potential dangers or risks of probiotics  to preterm infants. This caution arises from the tragic case of a preterm infant who received a probiotic product, leading to sepsis, a life-threatening condition, and ultimately the infant’s demise. While the letter did not specify the location of the incident, it underscored the serious concerns regarding probiotics’ use in hospital settings.

Furthermore, the FDA issued a warning letter to Abbott Laboratories concerning their product, Similac Probiotic Tri-Blend, which was being used in hospitals for preterm infants. This development raises questions about the safety and regulation to risks of probiotics products and the measures taken by manufacturers to ensure their products do not pose risks to vulnerable infants.

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Expert Recommendations and Ongoing Concerns

According to the report released by CNN, the American Academy of Pediatrics does not endorse the use of probiotics in preterm infants, highlighting the divide between risks of probiotics, medical recommendations, and current practices. The FDA’s recent actions bring to the forefront the potential risks associated with probiotics for infants, especially in hospital settings.

While these products are marketed as beneficial, the lack of FDA approval and growing evidence of adverse events undermines the urgent need for clearer regulations and guidelines surrounding the use of probiotics in the most vulnerable of populations. The risks of probiotics in infants raise pressing questions about their safety, effectiveness, and the responsibility of manufacturers and healthcare providers in ensuring the well-being of our youngest patients.

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