The products have contributed to at least one infant death this year, the FDA said
By Physician’s Briefing Staff HealthDay Reporter
FRIDAY, Oct. 27, 2023 (HealthDay News) — Federal regulators have sent warning letters to two companies for illegally selling probiotic products for use in preterm infants. The U.S. Food and Drug Administration also sent a letter to health care providers warning of the risks.
Probiotic products may be dangerous for preterm infants and are being illegally sold to treat or prevent diseases in preemies in hospitals, such as necrotizing enterocolitis. Those young babies who are given a probiotic product are at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast in the probiotics, the FDA said.
Certain products have contributed to invasive disease in hospitalized babies, including one death this year. They have been linked to more than two dozen other reported adverse events nationwide since 2018, according to the FDA.
No probiotic product is approved by the FDA for infants of any age. Products sold for this purpose have not gone through FDA safety evaluations or been checked for compliance with the agency’s rigorous manufacturing and testing standards. These products would need an approved Biologics License Application. Without the approval, health care providers who administer products containing live bacteria or yeast to treat or prevent disease are required to submit an Investigational New Drug application to the FDA.
A warning letter was sent to Abbott Laboratories on Oct. 24 for its Similac Probiotic Tri-Blend, which contains B. infantis (Bb-02), S. thermophilus (TH-4), and B. lactis (BB-12). Abbott has agreed to stop selling this product. The other warning letter was sent to Infinant Health, Inc. (formerly Evolve BioSystems Inc.) regarding its probiotic product, Evivo with MCT Oil. It has been voluntarily recalled and is no longer available in the United States.
“Protecting public health, especially of the most vulnerable populations such as preterm infants, is one of the highest priorities for the FDA,” James Jones, deputy commissioner for human foods at the FDA, said in an agency news release. “We are encouraging all involved in the care of preterm infants — including parents, caregivers, and health care providers — to be aware of the possible risks associated with the administration of probiotic products to preterm infants in hospital settings.”
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