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The U.S. Food and Drug Administration has issued a new warning about the risks of probiotics for hospitalized preterm infants. According to the agency, these products have been linked to more than 20 adverse events reported since 2018 and one death in 2023.
The agency announced Thursday that it sent a warning letter to the manufacturer, Abbott Laboratories, about its Similac probiotic triblend product, which the FDA said is an unapproved new drug and an unapproved biological product. According to the agency, the company has agreed to stop selling the product.
Abbott said in a statement Friday that the issue “relates to a single probiotic additive” in Similac Probiotic Tri-Blend, which is used in fewer than 200 hospitals. He said that. Does not apply to other Abbott infant formula products.
“Parents and caregivers can continue to find and use Similac infant formula across the country. This warning letter is not related to manufacturing quality issues. This product has been used for the past several years and is highly effective. “It has a strong safety profile,” the statement said.
Probiotics, which contain live bacteria and other microorganisms that provide health benefits, are commonly used as dietary supplements in the United States. Probiotic products are considered dietary supplements and are therefore not subject to the more stringent FDA approval process.
In hospitals, probiotics are often used to treat necrotizing enterocolitis, a life-threatening inflammation of the intestines in premature infants. The disease affects up to 1 in 20 infants and can kill about 1 infant every day, said Dr. Catherine Chetta, a pediatric neonatologist at the Medical University of South Carolina.
According to the American Academy of Pediatrics, about 10% of preterm infants receive probiotics while in the neonatal intensive care unit, and that number is steadily increasing across the United States. These are one of the “key tools” health care providers use to treat NEC, Chetta said.
However, the FDA remains skeptical of the use of probiotics for this disease. The agency said in a press statement that there are “conflicting data” about the safety and effectiveness of probiotics in preventing necrotizing enterocolitis. He called for more “high-quality clinical trials” that could provide conclusive evidence.
“Adverse events in infants following the use of probiotics are a concern to the FDA. We are particularly clear that products containing live microorganisms can pose a serious risk to preterm infants in the hospital. “We want to make this happen,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Earlier this month, the FDA also said that infants died After taking the probiotic Evivo containing MCT oil. Manufactured by Infinant Health for use in hospitals, this product includes: infant live bacterial subspecies Bifidobacterium longum. The baby developed sepsis caused by the same bacteria and died.
In a warning letter, the agency warned health care providers that the bacteria and fungi in probiotics can put preterm infants at risk of “aggressive and potentially fatal” infections. The product was recalled after the FDA sent a warning letter and is no longer available in the United States.
The FDA emphasized that it does not approve probiotic products for infants of any age, and the products have not been evaluated for safety, effectiveness, or compliance with manufacturing and testing standards.
“In today’s message, we remind parents, caregivers and healthcare professionals that when these products are used to prevent or treat disease, these products have been evaluated for safety, effectiveness and quality for medical use. “We would like to warn you that it has not gone through the agency’s rigorous pre-market process to ensure that it does not,” Marks added.
The American Academy of Pediatrics also does not recommend supplements for preterm infants.
“Given that there are no FDA-regulated pharmaceutical-grade products in the United States, conflicting safety and efficacy data, and the potential for harm to highly vulnerable populations, current evidence suggests that does not support the routine and universal administration of probiotics to preterm infants, especially when birth weight is less than 1000 g.” 2021 Clinical Report by Pediatricians Group.
But some doctors are concerned about the FDA’s opposition to probiotic therapy.
For many infants treated in hospitals, Chetta says antibiotic treatment changes the bacterial ecosystem, or microbiome, in the infant’s gut, leaving behind “bad” types of bacteria such as E. coli. “Good” types of bacteria can be killed, he explained. Probiotics can help reintroduce more diverse and healthy bacteria into an infant’s body, rebuilding the microbiome and preventing infections like NEC.
For Chetta, there is sufficient data to support the use of probiotics, especially since hospitals like hers choose probiotics with proven efficacy.
“We have great confidence in the probiotics we use,” Chetta said. “In fact, we know that using probiotics reduces infant sepsis, reduces the incidence of NEC, and reduces deaths.” That’s it.”
The chance of developing sepsis in infants given probiotics is about 1 in 5,000, much lower than the 1 in 20 chance of developing NEC infection, Chetta said. Also, when preparing to treat an infant with probiotics, she advises parents to consider the risks, including that the treatment is not FDA-approved, compared to its effectiveness as a treatment. is given the right to speak. For her, those benefits far outweigh the harm.
“The answer is not just to remove all probiotics,” she said. “The answer is to find safe solutions that allow babies to get the medicines and supplements they need.”
