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Following One Death, FDA Warns Hospitals About Giving Probiotics to Preemies

October 3, 2023


Federal regulators are cautioning doctors not to give probiotics to preterm infants.

An infant given probiotics at an undisclosed hospital has died, U.S. Food and Drug Administration officials said in a recent warning letter.

Preterm infants given probiotics are at risk of potentially fatal infection because of the bacteria and fungi that may be contained in those supplements, according to the FDA.

The infant who died weighed less than 2.2 pounds and was given the probiotic Evivo with MCT Oil as part of in-hospital care. The baby developed sepsis caused by a type of bacteria that turned out to be a genetic match to the bacteria contained in the probiotic, the FDA said.