The Food and Drug Administration is issuing a warning to hospitals regarding the administration of probiotics to preterm infants, following the death of a baby linked to a probiotic. The FDA has launched an investigation into the incident, which involved the use of Evivo with MCT Oil, a probiotic made by Infinant Health. This specific product is now being recalled.
The FDA stated that genomic sequencing data confirms that the bacterium responsible for sepsis in the infant is a genetic match to the bacteria found in this probiotic.
The name of the hospital that administered the probiotic being investigated by the FDA has not been disclosed. The agency’s spokesperson did not provide immediate comments.
Infinant Health has expressed its cooperation with the FDA’s investigation in a statement. The company has voluntarily agreed with the FDA to halt the shipment of its Evivo with MCT Oil product.
In an additional warning letter, the FDA accused Infinant Health of exceeding its role as a dietary supplement manufacturer. The company made medical claims about its product that elevate it to the level of an unapproved new drug and unlicensed biological product, which is illegal in the U.S.
Infinant Health intends to continue selling its “Evivo powder product” to consumers and is also planning to seek FDA approval for the use of its MCT oil product in hospital settings.
In a press release from May, Infinant Health had asserted that its Evivo probiotics are widely used by parents and hospitals, particularly in neonatal intensive care units throughout the United States.
Probiotics, such as those found in yogurt or supplements, are consumed for their health benefits. Some studies show that probiotics can help protect infants against certain illnesses.
Infinant Health makes various claims about the benefits of its Evivo product for consumers, including improved sleep, reduced diaper rash, and a healthy gut microbiome. The company emphasizes the importance of caring for a baby’s gut microbiome to promote good health.
The FDA cautions that no probiotics have been approved for use as drugs or biological products in infants. Therefore, probiotics are not subject to the FDA’s strict standards for manufacturing and testing that are required for other medications.
The American Academy of Pediatrics advises against widespread use of probiotics for preterm infants in a recent report. Hospitals are giving probiotics to about 1 in 10 extremely low gestational age babies, despite conflicting data on safety and efficacy.
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