As per the notification published on 29 September 2023, the United States Food and Drug Administration (US-FDA) has issued a critical safety alert to healthcare providers and the public regarding the usage of products containing live bacteria or yeast, commonly referred to as probiotics, in the care of preterm infants in hospital settings.

The US-FDA has released a Dear Healthcare Provider (DHCP) Letter to underscore the vital safety concerns associated with the use of probiotics in premature babies. This advisory was prompted by the alarming case involving a preterm infant who received Evivo along with medium-chain triglycerides (MCT) oil during in-hospital treatment. Tragically, this infant developed sepsis due to the bacterium Bifidobacterium longum, which ultimately led to a fatal outcome.

Recommendations:

• Risk of Invasive Disease: The FDA has strongly cautioned healthcare providers and parents that probiotics containing live bacteria or yeast pose a significant risk of invasive, potentially fatal illnesses in preterm infants. Several cases of bacteremia or fungemia, some with severe clinical consequences, have been documented in very preterm or very low birthweight infants.
• American Academy of Pediatrics Guidance: The American Academy of Pediatrics advises against the routine, universal use of probiotics in preterm newborns, particularly those having a birth weight below 1000 grams. This recommendation was based on concerns regarding the safety and effectiveness of such products, the lack of FDA-regulated pharmaceutical-grade probiotics in the United States, and the potential harm they may pose to this vulnerable population.
• FDA Approval: It is imperative to note that the US-FDA has not granted approval for any probiotic to be used as a biological product or drug in infants. Although there are unapproved and unlicensed probiotics in circulation intended for treating or preventing diseases or conditions in infants, such as reducing the risk of necrotizing enterocolitis in preterm infants, it's crucial to note that these products have not undergone the rigorous premarket review process mandated by the FDA to assess their safety and effectiveness. Furthermore, these products have not been examined for compliance with the FDA's stringent manufacturing and testing standards for therapeutic agents and biological products, which encompasses assessment for extraneous organisms.
• Investigational New Drug Application (IND): Medical care providers who administer probiotics containing live bacteria or yeast with the intention of treating, mitigating, curing, or preventing diseases or conditions are obligated to yield an Investigational New Drug Application (IND) to the FDA.

The FDA has urged healthcare providers to exercise extreme caution when considering the utilization of probiotics in preterm infants, emphasizing the potential risks and the lack of FDA approval.  Healthcare providers, parents, and caregivers must report any adverse events or side effects linked with the use of probiotics to the FDA's MedWatch program.