Infant's death prompts FDA warning on probiotics

An infant’s death has prompted the Food and Drug Administration (FDA) to issue a warning to medical professionals about giving probiotics to hospitalized preterm infants.

The FDA said that one infant developed sepsis and later died after the infant was given a probiotic while in hospital care. The FDA has previously sent a letter to health care providers advising them on the issue and sent two warning letters to companies for “illegally selling their products for use in treating or preventing certain diseases in preterm infants.”

“The FDA is concerned as these products can be dangerous for preterm infants and are being illegally sold to treat or prevent diseases in preterm infants in hospital settings, such as to reduce the risk of necrotizing enterocolitis,” the agency said in its statement.

“Preterm infants who are administered a probiotic product are at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast contained in the probiotics,” the FDA added.

Probiotics contain live organisms, including bacteria or yeast, and are commonly marketed as foods and in dietary supplements. Preterm infants given probiotics for enterocolitis — an inflammation of the intestines — could be at risk of developing a serious infection or even death, the FDA said.

Since 2018, the use of probiotics in preterm infants has been linked to 24 other reported adverse events, the agency said.

“The agency is also concerned about and is investigating reports that these products may have contributed to additional adverse events, including death, and is working to obtain the proper evidence and medical records, where possible,” the FDA said.

The agency also reiterated that it has not approved use of probiotics in infants of any age, saying that they have not been evaluated on safety or effectiveness.