The U.S. Food and Drug Administration (FDA) has issued a security warning to healthcare providers regarding the usage of probiotics in pre-term babies following the death of an infant at a hospital.
The premature baby, who was lower than 2.2 kilos, died at an unidentified hospital resulting from sepsis attributable to the identical species of bacteria present in the probiotics that were administered to them.
The infant was given the probiotic Evivo with MCT Oil manufactured by Infinant Health as a part of in-hospital care.
“A preterm infant, birthweight <1000 g, who was administered a probiotic, Evivo with MCT Oil (Infinant Health), as a part of in-hospital care, developed sepsis attributable to the bacterium Bifidobacterium longum and subsequently died," the FDA said in its warning letter. "The FDA is investigating the death of this preterm infant. Genomic sequencing data show the bacterium that caused sepsis on this infant was a genetic match to the bacteria contained on this probiotic."
The agency added that it has not approved the usage of any probiotic product as a drug in infants.
When probiotics are sold as a dietary complement, it doesn’t need FDA approval. Nevertheless, when it’s marketed as a drug for treating a selected disease or disorder, its safety and effectiveness needs to be proven through clinical trials before getting approval.
The agency said it has noticed several unapproved probiotics being sold out there for treating or stopping a disease or condition in infants, comparable to for reducing the danger of necrotizing enterocolitis (NEC) – a condition that may cause intestinal holes in premature babies because of this of tissue death within the intestine.
Microorganisms present in probiotics are potential causes of bacteremia or fungemia that may result in severe clinical complications, especially in extremely premature or very low birthweight (VLBW) infants, the FDA warns.
The American Academy of Pediatrics (AAP) doesn’t support the routine administration of probiotics to premature babies.
“Given the shortage of FDA-regulated pharmaceutical-grade products in the US, conflicting data on safety and efficacy, and the potential for harm in a highly vulnerable population, current evidence doesn’t support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of lower than 1,000 grams [2.2 pounds],” AAP said in an announcement.
The FDA requests healthcare providers and consumers to report adversarial events from the usage of probiotics each to the manufacturer and to the agency. The reports might be made on the FDA website or by calling 1- 800-FDA-1088.