Probiotic Products Pose Risks for Preterm Infants

Preterm infants with necrotising enterocolitis given a probiotic product face the potential danger of invasive, life-threatening infections resulting from the bacteria or yeast found in the probiotics. This caution follows a 2023 incident in which a probiotic was associated with the death of an infant (1^✔ ✔Trusted Source
FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants

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FDA Raises Concerns Over the Safety of Probiotic Products for Preterm Infants

The FDA said probiotic products, which contain live organisms such as bacteria or yeast and are commonly marketed as foods, including as dietary supplements, are used in hospitals to prevent necrotising enterocolitis in babies. It is a devastating intestinal disease that affects premature or very low birth weight infants. Symptoms may include poor feeding, bloating, decreased activity, blood in the stool, vomiting of bile, bowel death, multiorgan failure, and even death. However, the agency in a statement said “it is concerned as these products can be dangerous for preterm infants and are being illegally sold” in hospitals. Probiotics have also been associated with more than two dozen other reported adverse events in the US since 2018. The regulator called out on healthcare providers and also advised the general public of the possible risks. It also issued two warning letters to companies for illegally selling their products for use in treating or preventing certain diseases in preterm infants.

“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,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Importantly, the FDA said it “has not approved any probiotic product for use as a drug or biological product in infants of any age”.“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,” Marks said.

Reference:

1. FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants - (https://www.fda.gov/news-events/press-announcements/fda-raises-concerns-about-probiotic-products-sold-use-hospitalized-preterm-infants)

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