After the FDA told hospitals to not give preterm infants probiotics following one baby's death, the agency sent warning letters to Abbott Laboratories and Infinant Health.
Probiotics are commonly marketed as foods and dietary supplements, but none are approved for preterm infant use. They contain live organisms such as bacteria or yeast, which can cause invasive and potentially fatal diseases if they are administered to preterm infants, the FDA said Oct. 26.
An infant died at an undisclosed hospital after being given Evivo with MCT Oil, a probiotic made by Infinant Health that has since been recalled. Genomic sequencing data showed "the bacterium that caused sepsis in the infant was a genetic match to the bacteria contained in this probiotic," the FDA said.
While the agency is investigating the infant's death, it's also probing whether there are more adverse event cases, including death, from the use of probiotics.
Abbott's probiotic product, Similac Probiotic Tri-Blend, contained B. infantis, S. thermophilus and B. lactis, according to the FDA. The company agreed to discontinue selling the item after the FDA said it was marketing Similac for preterm infant use in hospitals. Abbott is working on additional corrective actions.
Infinant Health's product was marketed to be added to food for preterm infants despite lacking an approval or license for this indication, the FDA said. It is no longer available on the market.