The U.S. Food and Drug Administration (FDA) has issued a safety warning to healthcare providers regarding the use of probiotics in pre-term babies following the death of an infant at a hospital.

The premature baby, who was less than 2.2 pounds, died at an unidentified hospital due to sepsis caused by the same species of bacteria found in the probiotics that were administered to them.

The infant was given the probiotic Evivo with MCT Oil manufactured by Infinant Health as part of in-hospital care.

"A preterm infant, birthweight <1000 g, who was administered a probiotic, Evivo with MCT Oil (Infinant Health), as part of in-hospital care, developed sepsis caused by 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 demonstrate the bacterium that caused sepsis in this infant was a genetic match to the bacteria contained in this probiotic."

The agency added that it has not approved the use of any probiotic product as a drug in infants.

When probiotics are sold as a dietary supplement, it does not need FDA approval. However, when it is marketed as a drug for treating a specific disease or disorder, its safety and effectiveness should be proven through clinical trials before getting approval.

The agency said it has noticed several unapproved probiotics being sold in the market for treating or preventing a disease or condition in infants, such as for reducing the risk of necrotizing enterocolitis (NEC) – a condition that can cause intestinal holes in premature babies as a result of tissue death in the intestine.

Microorganisms found in probiotics are potential causes of bacteremia or fungemia that can lead to severe clinical complications, especially in extremely premature or very low birthweight (VLBW) infants, the FDA warns.

The American Academy of Pediatrics (AAP) does not support the routine administration of probiotics to premature babies.

"Given the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and the potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of less than 1,000 grams [2.2 pounds]," AAP said in a statement.

The FDA requests healthcare providers and consumers to report adverse events from the use of probiotics both to the manufacturer and to the agency. The reports can be made on the FDA website or by calling 1- 800-FDA-1088.

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