The US Food and Drug Administration (FDA) has issued a new warning regarding the use of probiotics for premature infants who are hospitalized. The FDA has reported over two dozen adverse events since 2018, including one death in 2023, linked to these products. The agency recently sent a warning letter to Abbott Laboratories regarding their Similac Probiotic Tri-Blend product, labeling it as an unapproved new drug and unlicensed biological product. Abbott has agreed to discontinue sales of the product. However, they have clarified that this warning does not apply to their infant formula products.
Probiotics, which are dietary supplements containing live bacteria or microorganisms, are commonly used in the US. But they are not subject to the rigorous FDA approval process. In hospitals, probiotics are often used to treat necrotizing enterocolitis (NEC), a life-threatening inflammation of the intestines in preterm infants. The American Academy of Pediatrics states that approximately 10% of preterm infants in neonatal ICUs receive probiotics. However, the FDA has cited conflicting data on the safety and effectiveness of probiotics for NEC prevention, calling for more high-quality clinical trials to provide definitive evidence.
The FDA’s concerns are primarily focused on the potential risks posed by live microorganisms in probiotics to preterm infants in hospital settings. They have highlighted that no probiotic products have been approved for use in infants of any age and that these products have not been evaluated for safety, effectiveness, or compliance with manufacturing and testing standards. The American Academy of Pediatrics also does not recommend the routine administration of probiotics to preterm infants due to the lack of FDA-regulated pharmaceutical-grade products in the US and conflicting data on their safety and efficacy.
Despite the FDA’s position, some physicians, such as Dr. Katherine Chetta, a pediatric neonatologist, support the use of probiotics for treating preterm infants in hospitals. Chetta explains that probiotics can help restore a diverse and healthy microbiome in these infants, reducing the risk of infections like NEC. While there is a small risk of sepsis associated with probiotics, Chetta believes the benefits outweigh the harms. She emphasizes the importance of finding a safe solution that allows babies to receive the necessary medications and supplements.
