Investigations found that a sepsis-causing bacterium, Bifidobacterium longum, genetically matched the bacteria in the probiotic produced by Infinant Health, per the FDA
The FDA has issued a safety alert concerning the use of probiotics in preterm infants within hospital settings. The warning comes after the death of a preterm infant who, according to the FDA, developed sepsis following the administration of the probiotic Evivo with MCT Oil.
Investigations found that the sepsis-causing bacterium — Bifidobacterium longum — genetically matched the bacteria in the probiotic produced by California-based Infinant Health. PEOPLE reached out to Infinant Health for comment, but did not receive an immediate response.
“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 said in a statement.
Highlighting the potential risks, the agency emphasized previous medical reports showing microorganisms in probiotics can cause serious health complications in preterm or low birthweight infants.
On its website, Infinant Health described their product as: "A ready-to-use, single-serve liquid probiotic containing bifidobacterium infantis with EVC001, clinically demonstrated to support an infant's gut microbiome. Evivo is designed for term infants."
The FDA emphasizes that it has not approved any probiotics for use as drugs or biological products in infants. As a result, probiotics don't undergo the stringent manufacturing and testing standards that other FDA-regulated medications do.
Probiotics are permitted for sale in the U.S. as dietary supplements, circumventing the FDA's stricter approval process for drugs and biologics. Typically, the dietary supplement category does not include items approved as new drugs, licensed as biologics, or authorized for clinical research under an effective investigational new drug application (IND).
Echoing the agency’s caution, the American Academy of Pediatrics advised against the universal administration of probiotics to preterm infants, especially those weighing less than 1000g (around two pounds), due to conflicting safety data and the potential for harm.
In a recent warning letter, the FDA accused Infinant Health of making medical claims that likened their product to an "unapproved new drug and unlicensed biological product," which is illegal to market in the U.S. Despite this, a spokesperson for Infinant Health stated the company plans to continue selling "Evivo powder product" to consumers, and are keen to collaborate with the FDA for the approval of their MCT oil product in hospitals.
In a May press release, Infinant Health stated that their Evivo probiotics are popular among parents and are also utilized in hospitals and neonatal intensive care units nationwide.
"We're so pleased that Evivo is a Mom's Choice Award recipient, which reflects what we at Infinant Health as well as parents and healthcare professionals across the country already know to be true – that Evivo can really make a difference in the health of babies," Anthony Franco, Chief Operating Officer for Infinant Health said in the press release.
The FDA stressed that it has not approved any probiotic product for use as a drug or biological product in infants. Despite this, the FDA said it is aware that some unlicensed probiotics are still being sold for disease treatment or prevention in infants, including reducing the risk of necrotizing enterocolitis (NEC) in preterm babies.
Healthcare providers are urged to be cautious, as these unapproved products haven't been subjected to the FDA's stringent premarket review processes.
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