The death of a premature baby was the spark launched by the US Food and Drug Administration to warn against the use of probiotics for this young age group.
In a letter sent by the federal agency, 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 the probiotic drug “Evivo” with “MCT Oil.” (Medium chain triglyceride oil).
The product, which is manufactured by Infinant Health for use in hospitals, contains strains of live bacteria. In detail, the baby born prematurely died after suffering from sepsis caused by the same type of bacteria, according to what was published by CNN.
Genetic sequencing data showed that the bacteria that caused this infant’s sepsis were genetically identical to the bacteria found in this probiotic, according to the US Food and Drug Administration.
It should be noted 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 percent of premature babies receive probiotics while in neonatal intensive care units, a number that is steadily increasing across the country.
Therefore, recent guidelines recommend not giving nutritional supplements to infants born prematurely.
A previous clinical report, issued by a pediatric group in 2021, noted that “given the lack of FDA-regulated pharmaceutical products 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, especially those with birth weights less than 1,000 g, is not supported.”
“The agency has not approved any probiotic product for use in infants,” the FDA explained in its letter. In September, it issued a public warning to Infinant Health calling Evivo with MCT Oil an “unapproved new drug and an 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.
In contrast, Infinant Health confirmed in a statement that it had agreed to recall Evivo with MCT Oil, and had notified health care providers and hospitals, indicating that it was “cooperating with the ongoing investigation by the Food and Drug Administration” into the infant’s death.
On the other hand, a review of 106 trials, including nearly 26,000 infants, published in JAMA Pediatrics, found that probiotics containing multiple strains of bacteria helped reduce infant mortality in general, and contributed to treating feeding intolerance and intestinal inflammation. Which threatens the life of infants, and is called necrotizing enterocolitis.
2023-10-06 09:11:00
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