FDA Issues Warning Against Probiotics For Infants
What's New Monday: Two probiotic products have been issued stop-sale notices due to an infant death
Today’s new article is a rather sad one. An infant died after receiving a dose of a probiotic that contained a single strain of Bifidobacteria mixed with MCT oil. MCT oil is a dietary supplement made from medium-chain triglycerides (MCTs). MCTs are saturated fats found in coconut and palm kernel oils. MCT oil is made through fractionation, which separates caprylic and capric acids from other fats in coconut or palm oil. MCT oil is generally safe, but you should avoid it if you are pregnant, lactating, diabetic, or have liver disease. Other drugs may interact with medium-chain triglycerides, including prescription and over-the-counter medicines, vitamins, and herbal products. See this article for more information: What to Know About MCT Oil
The quotes below are from Tin, Alexander. FDA investigating baby's death linked to probiotic given by hospital. October 2023. https://www.cbsnews.com/news/fda-warning-probiotics-preterm-infant-death-linked-evivo/:
Evivo with MCT Oil, a probiotic manufactured by California-based Infinant Health that is now being recalled.
"Genomic sequencing data demonstrate the bacterium that caused sepsis in this infant was a genetic match to the bacteria contained in this probiotic," the agency said.
Infinant Health makes a number of claims about its Evivo product for consumers, including that babies fed the probiotic have better sleep, less diaper rash and "a healthy gut microbiome."
The FDA warns that no probiotics have been approved for use as a drug or biological product in babies, meaning probiotics are not subject to the "agency's rigorous manufacturing and testing standards" for other medications regulated by the FDA.
In a separate article during the same week, Similac, made by Abbott Laboratories, also recalls their infant probiotic formula due to adverse reactions. The Similac formula contains three probiotic strains: B. infantis, S. thermophilus, and B. lactis. The Evivo product is a special strain of Bifidobacterium infantis EVC001.
Normally, these strains are beneficial and can be found in newborns within days after birth. The birth canal is where infants get their first dose of probiotics. Breast milk is the second. Both Bifidobacteria and Lactobacillus species are found in breast milk. None of the articles on the recalls have listed other ingredients in these products, such as fillers, aside from MCT oil in the Evivo product or anything of that nature. The Evivo website claims there are no other ingredients in their product. Unless these products had contaminants or fillers that could cause an allergic reaction, the pure probiotics should not have been a problem.
Here is a research paper on the Evivo product: Bajorek, S., Duar, R. M., Corrigan, M., Matrone, C., Winn, K. A., Norman, S., Mitchell, R. D., Cagney, O., Aksenov, A. A., Melnik, A. V., Kopylova, E., & Perez, J. (2021). B. Infantis EVC001 Is Well-Tolerated and Improves Human Milk Oligosaccharide Utilization in Preterm Infants in the Neonatal Intensive Care Unit. Frontiers in Pediatrics, 9. https://doi.org/10.3389/fped.2021.795970