CNN — The US Food and Drug Administration (FDA) has issued a warning regarding the potential risks of using probiotics for preterm infants in hospitals. The agency has received reports of over two dozen adverse events and one death related to these products since 2018. As a result, the FDA sent a warning letter to Abbott Laboratories, the manufacturer of Similac Probiotic Tri-Blend, which it classified as an unapproved new drug and unlicensed biological product. Abbott has agreed to discontinue sales of this particular probiotic additive, although it does not affect other Abbot infant formula products.
Abbott has reassured parents and caregivers that they can continue to use Similac infant formulas across the country, as this warning does not pertain to any manufacturing quality issues. The company claims that the product has been used safely for the past several years. Probiotics are commonly used as dietary supplements in the United States and are not subject to rigorous FDA approval processes.
In hospitals, probiotics are often used to treat necrotizing enterocolitis (NEC), a life-threatening condition that affects up to one in 20 preterm infants, leading to approximately one death per day. The use of probiotics in neonatal ICUs for treating NEC has been steadily increasing across the country. While healthcare providers consider them to be vital tools in the treatment of NEC, the FDA remains skeptical due to conflicting data regarding their safety and effectiveness. The agency has urged for more high-quality clinical trials to provide definitive evidence.
Recently, the FDA reported the death of an infant who received the probiotic Evivo with MCT Oil. The product contained a live bacterium called Bifidobacterium longum infantis and led to the infant developing sepsis caused by the same bacteria. The FDA highlighted the potential risk of invasive and potentially fatal infections in preterm infants due to bacteria and fungi found in probiotics.
The FDA emphasized that it has not approved any probiotic products for infants of any age and that these products have not undergone the necessary evaluations for safety, effectiveness, and compliance with manufacturing and testing standards. The American Academy of Pediatrics also does not recommend the routine administration of probiotics to preterm infants.
However, some physicians, such as Dr. Katherine Chetta, a pediatric neonatologist, believe in the benefits of probiotics in treating NEC. They argue that probiotics can help restore a healthy gut microbiome in preterm infants and reduce the risk of infections and death. Chetta acknowledges the lack of FDA-approved products but believes there is enough evidence supporting the use of probiotics in hospitals.
The debate surrounding probiotic therapy for preterm infants continues, with some physicians advocating for a safe solution that allows babies to benefit from the necessary medicines and supplements they require.
