Certain probiotics, the agency noted, have been linked to one infant death this year and over two dozen “adverse events” since 2018.
Probiotics have not been approved for use in infants by the FDA, nor is it recommended by the American Academy of Pediatrics. Yet,of “extremely low gestational age” newborns receive probiotics while in the neonatal intensive care unit, despite the potential risk the products pose.“We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings,” Dr.
The agency recently issued warnings to two companies — Abbott Laboratories and Infinant Health, Inc. — for marketing their probiotic products to infants and violating FDA regulations.
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