FDA Warns Against Using Probiotics in Preterm Infants After Baby’s Death


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WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) issued a grave warning to healthcare providers about the risks associated with administering probiotics containing live bacteria or yeast to preterm infants in hospitals. 

This follows a tragic event where a preterm baby, weighing less than 1000 grams, was given the probiotic “Evivo with MCT Oil” and later died due to sepsis caused by the bacterium Bifidobacterium longum. Genomic data confirmed the bacteria was a match to that in the probiotic. 

The FDA emphasizes that no probiotic product is FDA-approved for infants and urges reporting of any adverse effects to the agency.


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