Risk of invasive disease in preterm infants given Probiotics

The U.S. Food and Drug Administration (FDA) is providing important safety information to healthcare providers on the use of products containing live bacteria or yeast (commonly called probiotics) in preterm infants in hospital settings. Preterm infants taking probiotics are at risk of invasive disease and possible death from the bacteria and yeast contained in the probiotics.

Intestinal microbiome of the preterm infant

Over the past decade, the role of the intestinal microbiome as a marker of health and disease in preterm infants has been increasingly recognized. Differences in the intestinal microbiota among infants born at term and those born preterm have been demonstrated, with fewer bacterial species, less diversity, and increased proportions of potentially pathogenic strains in preterm infants. In addition, a number of factors are known to alter the microbiota in preterm infants, including mode of delivery, exposure to antibiotics, use of histamine antagonists, and diet (especially breast milk). 

Numerous studies have described intestinal dysbiosis preceding the onset of necrotizing enterocolitis (NEC) in preterm infants. Proposed benefits of probiotics include preventing intestinal dysbiosis and assisting in metabolism of dietary nutrients, leading to byproducts essential for intestinal health. For example, Bifidobacterium longum subspecies infantis consumes human milk oligosaccharides, promoting a healthy intestinal microbiota.

Effects of probiotics when administered to premature infants

The Food and Drug Administration (FDA) cautions that microorganisms contained in probiotics have been reported in the medical literature as causing bacteremia or fungemia, sometimes with a severe clinical course, in very preterm or very low birthweight infants. 

Moreover, the American Academy of Pediatrics states “Given the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of <1000 g.”

The FDA is also reminding healthcare providers that FDA has not approved any probiotic product for use as a drug or biological product in infants. The FDA is aware that some unapproved, unlicensed probiotics are nonetheless sold for use to treat or prevent a disease or condition in infants, including to reduce the risk of necrotizing enterocolitis (NEC) in preterm infants. Healthcare providers should be aware that these products have not undergone the FDA’s rigorous premarket review evaluation for safety and effectiveness, nor have they been evaluated for compliance with the agency’s rigorous manufacturing and testing standards for drugs and biological products, including testing for extraneous organisms.

Soure: U.S FDA