2023-10-04 13:36:06
Dubai, United Arab Emirates (CNN) – After the death of a premature baby after being given probiotics in the hospital, the US Food and Drug Administration warned hospitals against using this drug in infants who were born prematurely.
In a letter sent by the federal agency on Friday, the federal agency warned health care providers that “the bacteria and fungi found in probiotics may put infants born prematurely at risk of developing invasive, potentially fatal infections.” The letter cited the case of an infant who received Evivo probiotics with MCT Oil. (Medium chain triglyceride oil).
The product, which is manufactured by Infinant Health for use in hospitals, contains strains of live bacteria Bifidobacterium longum.
The letter indicated that the child died after suffering from sepsis caused by the same type of bacteria.
“Genetic sequencing data show that the bacteria that caused sepsis in this infant were genetically identical to the bacteria found in this probiotic,” the FDA letter stated.
It is known that the use of probiotics, which contain live bacteria or other microorganisms with health benefits, is common in the United States as nutritional supplements. Since it is considered a dietary supplement, it is not subject to the FDA approval process.
According to the American Academy of Pediatrics, about 10% of premature babies receive probiotics while in neonatal intensive care units, a number that is steadily increasing across the country.
The group’s latest guidelines also do not recommend nutritional supplements for infants who were born prematurely.
A previous clinical report dating back to 2021, issued by the Pediatrics Group, stated that “given the lack of pharmaceutical products regulated by the Food and Drug Administration in the United States, conflicting data on safety and effectiveness, and the potential for harm in high-risk populations, current evidence “Routine comprehensive administration of probiotics in premature infants is not supported, especially those with a birth weight of less than 1,000 grams.”
The FDA letter noted that the agency has not approved any probiotic product for use in infants. In September, it issued a public warning to Infinant Health calling Evivo with MCT Oil an “unapproved new drug and unlicensed biological product.”
The warning states that the company’s marketing of probiotics as a drug treatment violates several components of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.
Infinant Health said in a statement that it had agreed to recall Evivo with MCT Oil and had notified healthcare providers and hospitals.
The company noted, “We are cooperating with the ongoing investigation conducted by the Food and Drug Administration” into the infant’s death.
Recent research has found that probiotics may be a useful treatment option for premature babies.
A review of 106 trials, including nearly 26,000 infants, published Monday in the journal JAMA Pediatrics, found that probiotics containing multiple strains of bacteria helped reduce overall infant mortality and contributed to treating feeding intolerance and inflammation. Intestinal disease that threatens the life of infants, called necrotizing enterocolitis.
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