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  1. Medical Product Safety Information

Risk of Invasive Disease in Preterm Infants Given Probiotics Formulated to Contain Live Bacteria or Yeast

AUDIENCE: Consumers, Patients, Health Professionals

ISSUE: The U.S. Food and Drug Administration (FDA) is providing important safety information to healthcare providers on the use of products containing live bacteria or yeast (commonly called probiotics) in preterm infants in hospital settings.

BACKGROUND: FDA has issued a Dear Healthcare Provider (DHCP) Letter to provide important safety information to healthcare providers on the use of products containing live bacteria or yeast (commonly called probiotics) in preterm infants. The letter warns healthcare providers that preterm infants who are given probiotics are at risk of invasive, potentially fatal disease caused by the bacteria or fungi contained in probiotics, and includes information about a preterm infant who was administered Evivo with MCT Oil as part of in-hospital care who developed sepsis caused by the bacterium Bifidobacterium longum and subsequently died. 

RECOMMENDATIONS: 

  • The FDA cautions that microorganisms contained in probiotics have been reported in the medical literature as causing bacteremia or fungemia, sometimes with a severe clinical course, in very preterm or very low birthweight (VLBW) infants.1-4

  • Moreover, the American Academy of Pediatrics states “Given the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of <1000 g.”5

  • The FDA is also reminding healthcare providers that FDA has not approved any probiotic product for use as a drug or biological product in infants. The FDA is aware that some unapproved, unlicensed probiotics are nonetheless sold for use to treat or prevent a disease or condition in infants, including to reduce the risk of necrotizing enterocolitis (NEC) in preterm infants. Healthcare providers should be aware that these products have not undergone the FDA’s rigorous premarket review evaluation for safety and effectiveness, nor have they been evaluated for compliance with the agency’s rigorous manufacturing and testing standards for drugs and biological products, including testing for extraneous organisms.

  • The FDA reminds healthcare providers who administer probiotics containing live bacteria or yeast to treat, mitigate, cure, or prevent a disease or condition that they are required to submit an Investigational New Drug Application (IND) to the agency.

References:

¹⁻⁴ Case reports of bacteremia and fungemia from probiotic use in preterm infants:

https://pubmed.ncbi.nlm.nih.gov/27532215/, https://pubmed.ncbi.nlm.nih.gov/25472946/,

https://pubmed.ncbi.nlm.nih.gov/28133894/, https://pubmed.ncbi.nlm.nih.gov/32859326/

⁵ Poindexter B. Use of probiotics in preterm infants. Pediatrics 2021;147(6):June 2021:e2021051485.

https://publications.aap.org/pediatrics/article/147/6/e2021051485/180282/Use-of-Probiotics-in-Preterm-Infants

A copy of the DHCP letter can be found on FDA’s website here or at: 2023 Safety and Availability Communications | FDA

 

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