FDA Warns Against Giving Probiotics to Preterm Infants After Infection Death

Infant probiotics are classified as dietary supplements and not approved by the FDA as a form of medical treatment.

Following the death of an infant who was given a probiotic product in the hospital, federal regulators are cautioning against use of the dietary supplements among premature babies, due to the risk of infections.

The U.S. Food and Drug Administration (FDA) issued the warning in a letter to healthcare providers on September 29, advising that at least one preterm infant has died after recieving a priobiotic formulated to contain the live bacterium, Bifodobacterium lungum. The baby was given the probiotic as part of in-hospital care and developed sepsis, which ultimately killed the child.

As a result of the risk that bacteria and fungi may be found in probiotics, the agency has determined that the products should not be given to preterm infants, since they may cause invasive and potentially fatal infections.

Evivio Probiotic Leads to Infant Death

The death which led to the warning involved a preterm infant weighing less than 1,000 grams, or about 2 lbs, who was given Evivo with MCT Oil. The infant developed sepsis caused by bifidobacterium longum and died.

Evivo is an Infinant Health probiotic formulated to contain live bacteria to populate the good gut bacteria in an infant. It was advertised to treat or prevent necrotizing enterocolitis (NEC) in preterm infants. However, the product did not undergo FDA evaluation.

FDA investigators  matched the bacteria from the infant with bacteria found in Evivo using genome sequencing.  While most products contain multiple strains of bacteria, Evivo contained only the one.

As a result, the FDA issued a warning that the probiotic product could contain microorganisms that could cause bacteria and fungi that can lead to a serious infection in preterm or low birth weight infants.

Infinant Health agreed to recall the product and notify healthcare providers and hospitals.

Learn More About

Baby Formula Lawsuits

Premature infants fed Similac or Enfamil cow's milk formula faced increased risk of necrotizing enterocolitis (NEC) or wrongful death.


Infant Probiotic Risks

Products containing live bacteria or yeast, also known as probiotics, are often used in hospital settings and given to preterm infants. Based on past research involving more than 26,000 infants, probiotics are often administered to help prevent infant death, improve feeding intolerance among preterm infants, and improve inflammation of the intestines that can lead to NEC, which is life-threatening.

The FDA warning letter indicated the agency has not approved probiotic products to use as a drug or biological product for infants.

Probiotics are considered dietary supplements and are not regulated by the FDA. Roughly 10% of preterm infants in the U.S. receive probiotics during their hospital stay.

“Given 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 <1000 g,” the American Academy of Pediatrics said in a statement issued on October 2.

Healthcare providers or patients should report adverse events after the use of probiotics to the manufacturer and to the FDA using the MedWatch Adverse Event Reporting Program.


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