FDA Issues New Warning about Risks of Probiotics for Hospitalized Preterm Infants
The US Food and Drug Administration (FDA) has issued a new warning about the risks associated with probiotics for hospitalized preterm infants. According to the FDA, there have been over two dozen reported adverse events linked to probiotics since 2018, including one death in 2023.
In response to these concerns, the FDA sent a warning letter to manufacturer Abbott Laboratories regarding their Similac Probiotic Tri-Blend product. The FDA described the product as an unapproved new drug and unlicensed biological product. Abbott Laboratories has agreed to discontinue sales of the product in question.
Abbott Laboratories, in a statement, clarified that the issue is limited to a single probiotic additive for Similac Probiotic Tri-Blend and that it is used by fewer than 200 hospitals. The company reassured parents and caregivers that they can continue to find and use Similac infant formulas nationwide, as the warning letter does not apply to other Abbott infant formula products.
Probiotics, which contain live bacteria or other microorganisms that provide health benefits, are commonly used in the United States as dietary supplements. However, since probiotic products are considered dietary supplements, they are not subject to the same rigorous FDA approval process as drugs. The FDA has expressed skepticism about using probiotics to treat necrotizing enterocolitis (NEC), a life-threatening inflammation of the intestines in preterm infants. While probiotics are frequently used in hospitals to help treat NEC, the FDA has asserted that there is conflicting data about their safety and effectiveness for this purpose.
The American Academy of Pediatrics also does not recommend the use of probiotic supplements for preterm infants. According to a clinical report from the pediatrician group, there is insufficient evidence to support the routine administration of probiotics to preterm infants, particularly those with a birth weight of less than 1000 grams.
Despite the FDA’s concerns, some physicians argue in favor of probiotic therapy for hospitalized infants. Probiotics can help replenish healthy bacteria in the gut and prevent infections like NEC. Dr. Katherine Chetta, a pediatric neonatologist, states that the benefits of probiotics outweigh the risks, as there is a lower chance of developing sepsis from probiotics compared to the risk of NEC infection.
The FDA emphasized that it has not approved any probiotic products for infants of any age and that these products have not been evaluated for safety, effectiveness, or compliance with manufacturing and testing standards. They urge healthcare providers and caregivers to be cautious when using probiotics for the prevention or treatment of diseases, as these products have not undergone the FDA’s rigorous premarket evaluation process.
In conclusion, while probiotics are commonly used in hospitals to treat NEC in preterm infants, the FDA has issued a warning about the potential risks associated with their use. The agency calls for more high-quality clinical trials to provide definitive evidence on the safety and effectiveness of probiotics for this specific population. It remains to be seen how this warning will impact the use of probiotics in the treatment of preterm infants going forward.