JUNE 4, 2024

FDA Warning on Probiotics for Prevention of Necrotizing Enterocolitis Causes Shift in Care

Last fall, the FDA issued a warning letter ordering two manufacturers to stop selling probiotic products for use in preterm infants. This has put the agency at odds with some physicians who worry about the harm of not using these products in this vulnerable population.

Clinicians across the country had relied on specific probiotic products for reducing the risk for necrotizing enterocolitis (NEC) and death in preterm infants—an intervention supported by efficacy and safety data from more