The FDA warns about probiotics for hospitalized preterm infants. A preterm baby died earlier this month after receiving Evivo with MCT Oil probiotic in the hospital. The government is concerned about the risk that products with live bacteria pose to preterm infants. A letter was recently sent to healthcare providers warning them about this problem. The agency also issued two warning letters to companies for illegally selling their products for treating or preventing disease in preterm infants.
Probiotics contain live bacteria or yeast and are usually marketed as foods or dietary supplements. The FDA says that infants can develop sepsis if they are given these products. Some companies are illegally selling probiotics to treat or prevent diseases such as reducing the risk of necrotizing enterocolitis.
In addition to the infant death, the FDA says that these products have been associated with more than two dozen other reported adverse events in the United States since 2018. And the government is investigating reports that these products may have contributed to more illnesses and even death and is obtaining medical records.
The FDA has not approved any probiotic product for use as a drug or biological product in infants of any age. Unapproved, unlicensed probiotics that are used to treat to prevent disease in preterm infants have not undergone the agency’s premarket evaluation for safety and efficacy. And probiotics have not been evaluated for compliance with the FDA’s standards for drugs and biological products, including testing for other organisms.
A warning letter was issued to Abbott Laboratories on October 24, 2023, for its product, Similac Probiotic Tri-Blend, which contains B. infantis, S. thermophiles, and B. lactic. This product is not an infant formula and is not related to previous problems the agency has had with powdered infant formula manufactured by Abbott Nutrition. Abbott has agreed to stop sales of this product.
The agency also issued a warning letter to Infinant Health Inc for its probiotic product, Evivo with MCT Oil, as an unapproved and unlicensed product sold for use in treating or preventing disease in preterm infants. This is a violation of the FD&C Act and the Public Health Service Act. The product has been voluntarily recalled and is no longer available in the United States.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said in a statement, “Adverse events in any infant following the use of a probiotic are a concern to the FDA. We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings. With today’s message, we want to warn parents, caregivers and healthcare providers that if these products are used for the prevention or treatment of disease, they have not undergone the agency’s rigorous premarket process to evaluate their safety, effectiveness and quality for these medical uses.”
