The Food and Drug Administration has warned medical practitioners not to give probiotics containing live bacteria or yeast to preterm infants following its inquiry into the July death of a premature. The low-weight newborn got such a product in an unnamed hospital. The probiotic Evivo with MCT Oil, which is presently being recalled and is made by California-based Infinite Health, was involved in the fatalities, the FDA reported on Friday.
Additionally, the incident is the subject of an investigation. According to genome sequencing data, the bacteria in this probiotic had a genetic match to the germs that caused sepsis in this infant. Uncertainty exists about which hospital provided the probiotic under investigation by the FDA. An agency official was asked for comment but did not respond right away.
The FDA said Friday that Infinant Health had overstepped its limits as a maker of dietary supplements in a separate warning letter. The product’s medical claims were on par with an “unapproved new drug and unlicensed biological product” that would be prohibited from being sold in the United States.
According to a representative for Infinant Health, the company intends to keep selling its “Evivo powder product” to customers. They also want “to work with the FDA toward approval of the use of our MCT oil product in hospital settings.”
Consuming probiotics, which are beneficial bacteria, can improve a person’s health. According to studies, probiotics may help protect babies from certain diseases. One of the various benefits that customers of Infinant Health’s Evivo product are informed about is that babies who take the probiotic benefit from better sleep, fewer diaper rashes, and “a healthy gut microbiome.” 80% of our immune system is located in our gut.
If you’re a parent wondering whether you should feed your child probiotics. The firm claims that you must initially take care of the gut microbiota to provide your infant with a solid foundation for excellent health. The medicine can be started “right after birth” alongside breast milk, the business claims on its website in a medical FAQ.
Probiotics are not subject to the “agency’s rigorous manufacturing and testing standards” for other pharmaceuticals regulated by the FDA, the FDA advises, because none have been approved for use as a drug or biological product in newborns. Instead of having to pass the FDA’s stricter requirements for drug and biologic approval, probiotics can now be sold in the United States as dietary supplements. “Evivo is a food for special dietary use, meeting all FDA regulations for food products, and has been used by parents, hospitals, and providers for five years, with over 4.7 million feedings to date in over 60,000 babies,” the business stated in a news release in May.
The FDA also cited American Academy of Pediatrics advice cautioning against widespread use of probiotics for premature newborns. In the 2021 article, data were referenced that suggested hospitals were now giving probiotics to 1 in 10 “deficient gestational age” infants.
Necrotizing enterocolitis, a potentially fatal inflammation of the large intestine that affects babies, especially those who are premature and low-weight, is something that Infinant Health says its medicine can help prevent. The claim is contradicted by published evidence, and Infinite Health’s medicine has not undergone the FDA’s pre-market evaluation of efficacy and safety.
Additionally, the FDA has not approved its use in clinical trials. According to federal rules, Evivo with MCT Oil represented an unapproved new medication and contaminated food, according to the FDA’s warning letter to Infinite Health. But it’s not clear if Infinant knew about this beforehand.
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