FDA warns of ‘potentially fatal’ probiotic risk for preterm infants after patient dies

October 02, 2023

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The FDA has issued a safety alert warning patients and health care providers of a “risk of invasive, potentially fatal disease” linked to probiotic use among preterm infants in hospital settings.

The safety alert follows the death of a preterm infant, who was administered a probiotic formulated with Bifidobacterium longum bacteria as part of standard in-hospital care, and subsequently developed sepsis. Although the FDA investigation is ongoing, initial genomic sequencing has matched the sepsis bacteria to bacteria contained in the prescribed probiotic, Evivo with MCT Oil (Infinant Health).

The FDA has issued a safety alert warning patients and health care providers of a “risk of invasive, potentially fatal disease” linked to probiotic use among preterm infants in hospital settings.

“The FDA cautions that microorganisms contained in probiotics have been reported in the medical literature as causing bacteremia or fungemia, sometimes with a severe clinical course, in very preterm or very low birthweight infants,” the agency stated in the alert. “The FDA is also reminding health care providers that FDA has not approved any probiotic product for use as a drug or biological product in infants.”

Although several unlicensed probiotics containing live bacteria or yeast are advertised for the treatment or prevention of diseases in infants, including products intended to reduce necrotizing enterocolitis risk in preterm infants, the FDA emphasized that these products “have not undergone the FDA’s rigorous premarket review evaluation for safety and effectiveness.” Additionally, these products have not been subjected to the standardized testing typically given to drugs and biological products, “including testing for extraneous organisms,” the agency noted.

The FDA is encouraging health care providers and patients to report adverse events related to probiotic use to the administration’s MedWatch Safety Information and Adverse Event Reporting Program, as well as to the probiotic manufacturer using the address or phone number on the product label.

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