Skip to Main Content
Skip Nav Destination
Infant baby premature

Preterm infants given probiotics at risk of fatal disease: FDA warning letter

October 2, 2023

The Food and Drug Administration (FDA) is warning health care 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.

An FDA letter to providers includes information about a preterm infant who was administered Evivo with MCT Oil as part of in-hospital care. The infant developed sepsis caused by the bacterium Bifidobacterium longum and subsequently died. 

In 2021, the AAP released the clinical report Use of Probiotics in Preterm Infants, from the Committee on Fetus and Newborn, that included discussion of the potential risks of their use and the evidence in prevention and treatment of necrotizing enterocolitis (NEC) and late-onset sepsis.

The FDA letter relays the following safety recommendations:

  • 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 birth weight infants.
  • The FDA letter includes an excerpt from the AAP clinical report that 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.”
  • The 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 sold for use to treat or prevent a disease or condition in infants, including to reduce the risk of NEC in preterm infants. Health care providers should be aware that these products have not undergone the FDA’s premarket review evaluation for safety and effectiveness, nor have they been evaluated for compliance with the agency’s manufacturing and testing standards for drugs and biological products, including testing for extraneous organisms.
  • Health care providers who administer probiotics containing live bacteria or yeast to treat, mitigate, cure or prevent a disease or condition are required to submit an Investigational New Drug Application to the agency.


Close Modal

or Create an Account

Close Modal
Close Modal