FDA Warns Against Giving Probiotics to Preterm Infants Following Infant Death
McCreary County Record – The FDA has issued a warning to hospitals against administering probiotics to preterm infants after the death of a baby was linked to a specific probiotic product. The probiotic in question, Evivo with MCT Oil, manufactured by Infinant Health, is now being recalled.
The FDA investigation revealed that genom ic sequencing data found the same bacterium causing sepsis in the infant as the bacteria found in the Evivo probiotic. As a result, Infinant Health has voluntarily stopped shipping the product and is cooperating with the FDA.
In addition to the recall, the FDA has accused Infinant Health of making medical claims about the product that classify it as an unapproved new drug and unlicensed biological product. While Infinant Health plans to continue distributing its “Evivo powder product” for consumer use, the company intends to work with the FDA for approval of its MCT oil product in hospital settings.
Probiotics are bacteria consumed by individuals for their health benefits and can be found in yogurt or as supplements. Infinant Health claims that their Evivo probiotics are widely used by parents and in hospitals and neonatal intensive care units across the United States.
However, the FDA warns that no probiotics have been approved for use as drugs or biological products in babies, and they are only allowed to be sold as dietary supplements in the U.S. The FDA highlights the recommendations from the American Academy of Pediatrics, cautioning against the widespread use of probiotics for preterm infants.
According to a report from the American Academy of Pediatrics, current evidence does not support the routine administration of probiotics to preterm infants due to conflicting data on safety and efficacy and the potential for harm in a vulnerable population.
The FDA’s warning serves as a reminder for hospitals to exercise caution when considering the use of probiotics in preterm infants. Health professionals and parents are advised to consult with medical experts and adhere to the guidelines set forth by the American Academy of Pediatrics to ensure the safety and well-being of newborns. Infinant Health’s cooperation with the FDA’s investigation and commitment to work towards approval for hospital settings is a step towards addressing concerns surrounding the use of probiotics in preterm infants.
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