FDA warns hospitals not to use probiotics to treat premature babies

The U.S. Food and Drug Administration has issued a new warning against using probiotics to care for premature babies in the hospital.

Probiotics are live microorganisms that can affect the human body, such as by influencing the immune system or by helping maintain a balanced microbiome.

But the FDA warns that the live bacteria or yeast in probiotics can cause invasive and potentially fatal disease in preterm infants. In one case, a premature infant weighing less than 2.2 pounds developed sepsis and died after being treated with probiotics during in-hospital care. The FDA says its investigation into the death has shown the cause of sepsis was a genetic match for the bacterium in the probiotic.

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The American Academy of Pediatrics says "Given the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and 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 <1000 g."

There are no approved probiotic drugs for preterm infants, the FDA says. While some products are for sale on the market, the agency has not reviewed them for safety or effectiveness.