Infant Death Triggers FDA Warning About Probiotic Dietary Supplements

The Food and Drug Administration (FDA) has formally warned healthcare providers about using dietary supplements containing live bacteria or yeast in patients with compromised immune systems.

The warning explains that dietary supplements are not regulated in the United States as approved drugs: “these products are not subject to FDA’s premarket review or approval requirements for safety and effectiveness, nor to the agency’s rigorous manufacturing and testing standards for drugs, including testing for extraneous organisms.” But, according to the warning, health care professionals use some dietary supplements “to treat, mitigate, cure, or prevent a disease or condition.”

The warning follows the October 11 death of a premature Connecticut infant from an invasive fungal disease of the gastrointestinal tract, called mucormycosis, after receiving a probiotic supplement in a hospital neonatal intensive care unit, Forbes reports. The Centers for Disease Control and Prevention (CDC) identified the fungus Rhizopus oryzae in unopened bottles of ABC Dophilus, made by Solgar Inc. of Leonia, New Jersey. The dietary supplement, marketed for use in infants and children, contains three viable bacteria strains that the company claims, “support good health in these populations by helping to maintain a healthy balance within the intestine’s microbial ecology.”

On November 17, Solgar announced a voluntary recall of three lots of the product that were distributed in 30 states, the UK, and Israel. The FDA, the CDC, and the Connecticut Department of Health are investigating how the infant, born at 29 weeks gestation, was treated after developing necrotizing enterocolitis (NEC), which can occur in premature infants whose organs have not finished developing. The intestines of a premature infant may not be able to exclude bacteria and a lethal infection can result, according to Forbes.

The Cochrane Collaborative conducted a review of 24 clinical studies on probiotic supplements and concluded that, “Enteral supplementation of probiotics prevents severe NEC and all cause mortality in preterm infants.” The FDA said this review is the rationale that the Connecticut health professionals used in justifying inpatient use of a dietary supplement. But a review by the U.S. Agency for Healthcare Research and Quality (AHRQ) cited the incomplete nature of safety assessment of these supplements. Probiotic supplements vary considerably in their composition and delivery method, Forbes reports. In the infant fatality case, the fungal contamination of unopened bottles of ABC Dophilus implies an issue with manufacturing conditions.