FDA Issues Warning to Hospitals About Probiotics After Death Reported

A sign for the Food And Drug Administration is seen outside of the headquarters in White Oak, Maryland, on July 20, 2020. (Sarah Silbiger/Getty Images)

The U.S. Food and Drug Administration (FDA) issued a warning to hospitals not to give probiotics to preterm infants after a baby recently died.

In a warning published last week, the agency said that an investigation in the case was opened after a preterm infant was given the probiotic Evivo with MCT Oil, made by Infinant Health, as part of in-hospital care. The child later “developed sepsis caused by the bacterium Bifidobacterium longum and subsequently died,” the health regulator said.

“Genomic sequencing data demonstrate the bacterium that caused sepsis in this infant was a genetic match to the bacteria contained in this probiotic,” the FDA’s letter stated.

It’s not clear what hospital administered the probiotic, which contains the infantis subspecies of the live bacterium Bifidobacterium longum, Other details about the incident weren’t provided.

Preterm infants who are given probiotics can risk developing a fatal infection because of the bacteria or fungi contained in the products, said the FDA. Probiotics are not approved for use as a drug or biological product in babies, the FDA said, adding that they are a supplement that is not subjected to the agency’s “rigorous manufacturing and testing standards.”

“The FDA is also reminding healthcare providers that FDA has not approved any probiotic product for use as a drug or biological product in infants,” the agency’s letter stated. “The FDA is aware that some unapproved, unlicensed probiotics are nonetheless sold for use to treat or prevent a disease or condition in infants, including to reduce the risk of necrotizing enterocolitis (NEC) in preterm infants.”

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The American Academy of Pediatrics issued guidelines on probiotics, saying due to the “lack of FDA-regulated pharmaceutical grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of less than [2.2 pounds].”

The group cited data that suggests one in 10 “extremely low gestational age” babies are now being given probiotics by hospitals.

Infinant Health told CBS News that it is “cooperating with FDA’s ongoing investigation” and has agreed to stop distributing the Evivo with MCT Oil product.

In a May news release, Infinant Health said its products are popular among parents and are used in hospitals around the United States, including in neonatal intensive care units.

The product is “clinically shown to work with breast milk,” the company says on its website, adding that “Evivo helps establish a healthy gut microbiome to support healthy digestive and immune function.”

“Parents of babies who take Evivo report their babies have less gas and fussiness, improved sleep, improved stooling, and relief from diaper rash,” it adds. “Evivo is clinically shown to be safe for babies.”

Despite the FDA’s claims, a survey of 106 trials involving some 26,000 infants, which was published in JAMA Pediatrics on Monday, found that probiotics with several strains of bacteria can reduce infant deaths overall. The survey also found that it can reduce inflammation of the intestines caused by necrotizing enterocolitis.

Probiotics are a type of bacteria that are consumed for health benefits and are found in yogurt, kefir, and supplements. Evivo with MCT Oil contains only one strain of bacteria.

In September, the FDA sent out a public warning to Infinant Health and described Evivo with MCT Oil as “an unapproved new drug and unlicensed biological product.”

“Because their gastrointestinal system is not fully matured, preterm infants have more permeable intestinal linings, often referred to as ‘leaky guts,’ and motility problems, which can lead to opportunistic infections and sepsis when ingesting living microorganisms,” the letter stated. “The current published literature does not show consensus among qualified experts that the use of living microorganisms in preterm infants is safe.”

The Epoch Times has contacted Infinant for comment.