FDA Issues Warning About Probiotic Use in Infants Linked to Death, Illnesses This Year

Probiotics could have fatal consequences for infants, the Food and Drug Administration (FDA) has warned.

The agency issued a warning on Thursday that probiotics — which contain live bacteria and yeasts — are potentially dangerous for pre-term babies, putting them “at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast contained in the probiotics.”

The FDA raised concerns over probiotics that are illegally sold and marketed as products to treat or prevent certain diseases in hospital settings, like necrotizing enterocolitis, a lethal intestinal disease that commonly affects pre-term babies.

Certain probiotics, the agency noted, have been linked to one infant death this year and over two dozen “adverse events” since 2018.

Probiotics have not been approved for use in infants by the FDA, nor is it recommended by the American Academy of Pediatrics. Yet, an estimated 10% of “extremely low gestational age” newborns receive probiotics while in the neonatal intensive care unit, despite the potential risk the products pose.

“We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

“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.”

The agency recently issued warnings to two companies — Abbott Laboratories and Infinant Health, Inc. — for marketing their probiotic products to infants and violating FDA regulations.

Infinant Health, Inc.’s “unapproved and unlicensed” Evivo with MCT Oil was marketed as a food additive for pre-term infants in a hospital setting, resulting in a voluntary recall of the product.

Similarly, Abbott Laboratories’ Similac Probiotic Tri-Blend has been discontinued after it was sold with the intention “for use in hospital settings for preterm infants,” according to the FDA.

“This issue pertains to a single probiotic additive for formula called Similac Probiotic Tri-Blend, which is used by fewer than 200 hospitals,” a spokesperson from Abbott Laboratories told The Post in a statement.

“Importantly, this does not apply to any of Abbott’s infant formula products available at retail, and parents and caregivers can continue to find and use Similac infant formulas nationwide.”

They noted that the warning letter did not pertain to manufacturing quality issues.

“This product has been used for the past several years and has had a strong safety profile,” they said.

“Protecting public health, especially of the most vulnerable populations such as preterm infants, is one of the highest priorities for the FDA,” Jim Jones, the FDA’s Deputy Commissioner for Human Foods, said in a statement, vowing further investigation into unsafe products.

“We are encouraging all involved in the care of preterm infants, including parents, caregivers and healthcare providers, to be aware of the possible risks associated with the administration of probiotic products to preterm infants in hospital settings.”