During the fall of 2023, the FDA issued a series of
warnings about the use of probiotics in preterm infants.
The FDA reported that an infant died after receiving
a commercially available probiotic . It contained the infantis subspecies of the live bacterium
Bifidobacterium longum. The infant died after developing
sepsis from the bacterium, which was a genetic match
to the bacteria contained in this probiotic product.
Probiotic use in preterm infants has been associated
with more than two dozen other reported adverse
events in the United States since 2018.

The FDA reminded healthcare providers that these products have
neither undergone an FDA premarket review evaluation for safety and effectiveness nor have been
evaluated for compliance with the agency’s manufacturing
and testing standards for drugs and biological products,
including testing for extraneous organisms.

Given the ongoing controversy regarding the use of
probiotics for hospitalized preterm infants, the fact that
the FDA has not approved any probiotic product for
use as a drug or biological product in infants, and
the known NEC risk reduction effect of human milk,
lactation personnel may wish to
improve breastfeeding practices in the NICU as an
important intervention in reducing the risk of NEC
and to consider implementing evidence-based breast-
feeding and human milk feeding policies and practices,
such as those that incorporate baby-friendly principles
into the NICU.

Suggestions for improving breastfeeding practices in the NICU will be provided.