HEALTH
FDA Warns Probiotics Used For Premature Babies Carry Potentially Deadly Health Risks
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The U.S. Food and Drug Administration on Thursday expanded its warning that probiotic products used for hospitalized premature infants carry potentially fatal health risks, after at least one infant died.
The FDA on Sept. 29 warned healthcare providers not to give certain probiotics to infants after it launched an investigation into the death of a baby caused by bacteria linked to a probiotic. The baby’s death followed the use of Evivo with MCT Oil, a probiotic manufactured by California-based Infinant Health, which has since been recalled.
Genomic sequencing data demonstrate the bacterium that caused sepsis in this infant was a genetic match to the bacteria contained in this probiotic, the agency said.
In addition to one infant death, the FDA said Thursday that probiotic products were associated with more than two dozen reports of adverse events in the U.S. since 2018. The agency is also working to collect medical records and other evidence for possible additional adverse events, including death.
The agency expanded its warning to all probiotic products that contain live bacteria or yeast, saying they pose possible risks to preterm infants.
The probiotics used in hospital settings are meant to prevent necrotizing enterocolitis, which almost exclusively affects newborns and carries a mortality rate of up to 50%, according to the National Institutes of Health. But the FDA pointed out that it has not approved any probiotic product for use as a drug or biological product in infants of any age.
Probiotics are often marketed as foods or supplements, and the FDA said it is concerned probiotic products are being illegally sold to treat or prevent diseases in preterm infants in hospital settings.
“Adverse events in any infant following the use of a probiotic are a concern to the FDA. We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings,” Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research said in a statement.
With todays message, we want to warn parents, caregivers and healthcare providers that if these products are used for the prevention or treatment of disease, they have not undergone the agencys rigorous premarket process to evaluate their safety, effectiveness and quality for these medical uses, Marks said.
Following the recall of Infinant Health’s Evivo with MCT Oil product, the FDA on Tuesday issued a warning letter to Abbott Laboratories in connection to its Similac Probiotic Tri-Blend. The agency said Abbott has agreed to discontinue sales of the product and is working with the FDA to take additional corrective actions.
We are encouraging all involved in the care of preterm infants, including parents, caregivers and healthcare providers, to be aware of the possible risks associated with the administration of probiotic products to preterm infants in hospital settings, said Jim Jones, the FDAs Deputy Commissioner for Human Foods. The FDA continues to investigate these incidents and is committed to using our available resources and authorities to identify and address potentially unsafe products in the market.
TMX contributed to this article.
