FDA has also issued two warning letters to Abbott Laboratories and Infinant Health for illegally selling their products for use in the treatment or prevention of certain diseases in preterm infants
FDA’s campus of Center for Drug Evaluation and Research. (Credit: The U.S. Food and Drug Administration from Wikimedia Commons)
The US Food and Drug Administration (FDA) has warned the public, including healthcare providers about the potential risk posed by probiotic products sold for use in hospitalised preterm infants.
The health agency has recently sent a letter to healthcare providers warning them about the possible risks of products containing live bacteria or yeast.
FDA has also issued two warning letters to firms for illegally selling their products for use in the treatment or prevention of certain diseases in preterm infants.
According to the health regulator, probiotic products are frequently advertised as foods, including dietary supplements, and include live organisms like yeast or bacteria.
The FDA is concerned because these medications are being illegally sold to treat or prevent diseases in preterm newborns in hospital settings, such as lowering the risk of necrotising enterocolitis.
The bacteria or yeast in the products could induce an invasive, potentially deadly illness or infection, the US agency claimed.
The FDA said several probiotics used in hospital settings to prevent necrotising enterocolitis are related to over two dozen other reported adverse events in the US since 2018. These products have also led to invasive diseases, including one newborn death in 2023.
FDA human foods deputy commissioner Jim Jones said: “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.
“The FDA continues to investigate these incidents and is committed to using our available resources and authorities to identify and address potentially unsafe products in the market.”
The agency issued a warning letter to Abbott Laboratories for Similac Probiotic Tri-Blend which contains B. infantis (Bb-02), S. thermophilus (TH-4) and B. lactis (BB-12).
Abbott has agreed to stop the sale of this product and is working with the FDA for corrective actions.
In addition, the American health regulator issued a warning letter to Infinant Health in September for its probiotic product, Evivo with MCT Oil. It is an unapproved and unlicensed product sold for use in treating or preventing disease in preterm infants.
The product was already voluntarily recalled and is no longer available in America.