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As per the FDA, the administration of probiotics formulated to contain live bacteria or yeast to preterm infants in hospital settings poses a significant risk of invasive, potentially fatal diseases.
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:
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.
US-FDA
Risk of Invasive Disease in Preterm Infants Given Probiotics Formulated to Contain Live Bacteria or Yeast
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