Probiotic bacterium kills preterm infant; FDA blasts supplement maker

Enlarge / A premature baby in the neonatal intensive care unit at University of Iowa Stead Family Children's Hospital in Iowa City, Iowa on August 13, 2021. The baby was born two days earlier at 22 weeks and at birth weighed just 1 lb., 0.1 oz. (credit: Getty | Michael S. Williamson/The Washington Post)

The Food and Drug Administration is warning health care providers not to use probiotics containing live bacteria or yeast in preterm infants after the agency began investigating the July death of a preterm, low-weight infant given such a product in an unnamed hospital.

The infant developed sepsis from the bacterium in the probiotic product—Evivo with MCT Oil made by Infinant Health—and subsequently died.

In a statement to Ars, the FDA said it quickly investigated the death after receiving an initial report on July 31. "Infant deaths are especially tragic and determining causality of preterm infant death can be particularly complicated," an agency spokesperson said. The agency reviewed medical records and laboratory tests from the case and collected clinical samples and product samples for analysis.