FRIDAY, Oct. 27, 2023 (HealthDay News) — Federal regulators have sent warning letters to two companies illegally selling probiotic products for use in premature infants. The FDA also issued a letter to health care providers warning of these risks.
Probiotic products can be dangerous to premature infants and are illegally sold to treat or prevent illnesses such as necrotizing enterocolitis in premature infants born in the hospital. The FDA says young infants who take probiotic products are at risk for invasive, potentially fatal illnesses or infections caused by the bacteria or yeast in the probiotics.
Some products have caused invasive illnesses in hospitalized babies, including the death of one baby this year. They have been linked to more than two dozen adverse events reported across the country since 2018, according to the FDA.
The FDA has not approved any probiotic products for use in infants of any age. Products marketed for this purpose have not been evaluated by the FDA for safety or inspected for compliance with the agency’s strict manufacturing and testing standards. These products require an approved biologics license application. Healthcare providers who use products containing live bacteria or yeast to treat or prevent disease must submit an investigational new drug application to the FDA without approval.
On October 24, Abbott Laboratories received a warning letter regarding its Similac Probiotic Tri-Blend, which contains Bifidobacterium infantis (Bb-02), Streptococcus thermophilus (TH-4), and Bifidobacterium lactis (BB-12). Abbott has agreed to stop selling the product. Another warning letter was sent to Infinant Health, Inc. (formerly Evolve BioSystems Inc.) regarding its probiotic product Evivo with MCT Oil. It has been subject to a voluntary recall and is no longer sold in the United States.
“Protecting the public health, especially the health of the most vulnerable populations, such as premature infants, is one of FDA’s top priorities,” James Jones, FDA deputy commissioner for human foods, said in an agency news release. “We encourage participation Everyone involved in the care of preterm infants—including parents, caregivers, and health care providers—is aware of the possible risks of giving probiotic products to preterm infants in the hospital setting.”