After a newborn died, the Food and Drug Administration is now urging hospitals not to provide probiotics to premature infants.
The FDA stated in a notice released on September 29 that an investigation has also been opened into the fatality after using Evivo with MCT Oil, a probiotic produced by California-based Infinant Health that is currently being recalled.
According to the FDA, genome sequencing results show that the probiotic bacteria and the bacterium that led to the infant's sepsis were genetically related.
A spokesman says the firm has voluntarily agreed with the FDA to stop distributing their Evivo with MCT Oil products.
"That product was used by health care professionals in hospital settings, including neonatal care for preterm infants."- Evivo
The FDA asserted that Infinant Health had overstepped its bounds as a producer of nutritional supplements in a second warning letter dated September 29. The product's medical claims were comparable to an "unapproved new drug and unlicensed biological product" that would be prohibited from being sold in the United States.
The firm intends to keep selling its Evivo powder product to customers, according to a representative for Infinant Health. They also want "to work with the FDA toward approval of the use of our MCT oil product in hospital settings."
Are probiotics dangerous for newborns?
Consuming probiotics, which are beneficial microorganisms, can improve one's health. According to studies, probiotics may help protect babies from some disorders. Consumer-facing claims made by Infinant Health regarding their Evivo product include that infants given the probiotic enjoy improved sleep, fewer diaper rashes, and "a healthy gut microbiome."
The gut contains 80% of the immune system, the organization continues.
The manufacturer claims, on their website, that the medicine may be started "right after birth" with breast milk. The FDA advises that probiotics are not subject to the "agency's rigorous manufacturing and testing standards" for other pharmaceuticals regulated by the FDA because no probiotic has been licensed for use as a drug or biological product in newborns.
Probiotics can instead be purchased in the U.S. as nutritional supplements, avoiding the FDA's stricter requirements for approving drugs and biologics.
According to the company's news release from May, Evivo is a meal for particular dietary usage that complies with all FDA requirements for food products. Parents, hospitals, and providers have used it for five years, with more than 4.7 million feedings in more than 60,000 infants.
The report concludes: "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."
- FDA. WARNING REGARDING USE OF PROBIOTICS IN PRETERM INFANTS.
- FDA. Infinant Health, Inc formerly Evolve Biosystems Inc.
- Cision PR Newswire. Infinant Health, Inc Announces Evivo® is Mom's Choice Award Recipient.
- American Academy of Pediatrics. Use of Probiotics in Preterm Infants.