FDA Issues Stern Warning Against Probiotics for Preterm Infants Following Tragic Death

The U.S. Food and Drug Administration (FDA) has issued a stern warning to healthcare providers and parents about the potential dangers of administering probiotics to premature infants. This cautionary announcement comes in the wake of a tragic incident where a premature infant lost its life after being given a probiotic supplement while in hospital care.

The infant was administered a probiotic product known as Evivo with MCT Oil, manufactured by Infinant Health of Norwalk, Connecticut. The product contains a live bacterium called Bifidobacterium longum subsp. infantis. Genetic sequencing confirmed that this bacterium was responsible for causing sepsis in the infant, leading to its untimely death.

Probiotic supplements are often used to prevent necrotizing enterocolitis, a dangerous infection that affects premature infants. This condition inflames and kills intestinal tissue, affecting up to 9,000 infants annually with a mortality rate of approximately 50 percent. However, if probiotic bacteria enter the bloodstream, it can lead to sepsis, a potentially fatal condition.

Despite these potential benefits, no probiotic products have been approved as a drug or treatment for babies. As dietary supplements, probiotics are not subject to the FDA approval process. The American Academy of Pediatrics (AAP) also does not recommend the use of probiotics in babies, citing a lack of evidence supporting their health benefits.

In addition to the tragic death, the FDA has received more than two dozen reports of injuries since 2018 that may be linked to these supplements. The agency is currently investigating additional reports of injuries and deaths associated with probiotic use in preterm infants.

The FDA has taken action against companies accused of illegally marketing probiotic products. Abbott Laboratories, which was at the center of a recall and nationwide shortage of powdered infant formula last year, received a warning letter from the FDA. Following this, the Illinois-based company agreed to halt sales of its Similac Probiotic Tri-Blend product and cooperate with the FDA on additional corrective actions.

Infinant Health, the manufacturer of the probiotic product linked to the infant’s death, has voluntarily recalled and discontinued the product. The company issued a statement confirming these actions, emphasizing their commitment to ensuring the safety of their products.

In light of these developments, it is crucial for healthcare providers and parents to exercise caution when considering the use of probiotics in preterm infants. The potential risks associated with these products underscore the need for rigorous testing and regulatory oversight to ensure the safety and well-being of our most vulnerable population.