Preterm infants should not be given probiotics, as the products can pose serious risk to babies and have been linked to at least one death, the Food and Drug Administration said Thursday. The infant death linked to probiotics occurred this year, the FDA said. Since 2018, there have been more than two dozen adverse events in infants linked to the products, and the agency is investigating whether probiotics have contributed to other cases in babies.
The FDA also said Thursday that it sent a warning letter to Abbott Laboratories on Tuesday about one of its products, Similac Probiotic Tri-Blend, which was being sold for use in preterm infants in hospitals. It contains three bacterial strains: B. infantis, S. thermophilus and B. lactis. It’s unclear whether the product led to any adverse events in babies, but Abbott agreed to discontinue sales and is working with the FDA to “take additional corrective actions,” according to the agency.