FDA Warns Hospitals Against Giving Probiotics to Preterm Infants After Infant Death
The Food and Drug Administration (FDA) has issued a warning to hospitals, urging them to refrain from administering probiotics to preterm infants. This comes after an investigation was initiated into the death of a baby that was linked to a probiotic. The FDA issued the warning in a statement published on Friday, along with a recall of Evivo with MCT Oil, a probiotic manufactured by Infinant Health, based in California.
According to the FDA, genomic sequencing data revealed that the bacterium that caused sepsis in the infant matched the bacteria found in the recalled probiotic. The agency, however, did not disclose which hospital administered the probiotic that is currently under investigation. The FDA is yet to comment on the matter.
Infinant Health, in response to the FDA warning, stated that it is cooperating with the ongoing investigation. The company has agreed to discontinue shipping its Evivo with MCT Oil product, which was used in hospital settings, including neonatal care for premature infants.
In a separate warning letter issued on Friday, the FDA accused Infinant Health of exceeding its boundaries as a dietary supplement manufacturer. The agency claimed that the medical claims made by the company regarding the product were comparable to an unapproved drug and a biological product, which would be illegal to sell in the United States.
Despite the recall, Infinant Health plans to continue distributing its “Evivo powder product” for consumer use and intends to work with the FDA to seek approval for the use of its MCT oil product in hospital settings.
In May, Infinant Health had touted the popularity of its Evivo probiotics, claiming that they were widely used by parents, hospitals, and neonatal intensive care units throughout the United States. Probiotics are consumed for their health benefits and are found in products such as yogurt and supplements. Some studies have shown benefits for infants in terms of disease prevention.
However, the FDA warns that no probiotics have been approved for use as drugs or biological products in babies. Probiotics are classified as dietary supplements and are not subject to the stringent manufacturing and testing standards imposed by the FDA on other medications.
The FDA also highlighted recommendations from the American Academy of Pediatrics, which discourage the widespread use of probiotics for preterm infants. A report in 2021 cited data suggesting that 1 in 10 extremely low gestational age babies were being given probiotics by hospitals.
In light of the lack of FDA-regulated pharmaceutical-grade probiotic products, conflicting data on safety and efficacy, and the potential for harm in a vulnerable population, the report’s authors concluded that there is not enough evidence to support the routine and universal administration of probiotics to preterm infants.
As the investigation into the infant death continues, the FDA’s warning serves as a reminder for healthcare professionals and parents to exercise caution when considering probiotic use in preterm infants until further research is conducted.