These products may be dangerous for preterm infants and are being illegally sold to treat or prevent diseases in preemies in hospitals, such as necrotizing enterocolitis.who are given a probiotic product are at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast in the, including one death this year. They have been linked to more than two dozen other reported adverse events nationwide since 2018, according to the FDA.
No probiotic product is approved by the FDA for infants of any age. Products sold for this purpose have not gone through FDA safety evaluations or been checked for compliance with the agency's rigorous manufacturing and testing standards. “Protecting public health, especially of the most vulnerable populations such as preterm infants, is one of the highest priorities for the FDA,” said James Jones, deputy commissioner for human foods.