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The FDA warned the public Thursday that certain probiotic products given to preterm infants in hospital settings are potentially dangerous.
The agency also sent warning letters to Abbott Nutrition and Infinant Health, two makers of probiotic products that the FDA said violate federal laws.
“Preterm infants who are administered a probiotic product are at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast contained in the probiotics,” the agency said, noting that such probiotic products have been linked to one infant death this year, and “two dozen other reported adverse events” in the U.S. since 2018.
The FDA is also currently investigating additional reports that these products may have contributed to adverse events, including death.
“With today’s message, we want to warn parents, caregivers and healthcare providers that if these products are used for the prevention or treatment of disease, they have not undergone the agency’s rigorous premarket process to evaluate their safety, effectiveness, and quality for these medical uses,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
The agency recently sent a letter to healthcare providers warning about the dangers of products containing live microorganisms marketed for use in preterm infants.
Marketers of such products often claim they reduce the risk of necrotizing enterocolitis, a serious and often deadly gastrointestinal disease in preterm infants, among other benefits.
Preterm infants are more susceptible to infections and sepsis from live microorganisms because their gastrointestinal system is not yet fully developed and their gastrointestinal linings are more permeable, the FDA explained.
“FDA has not approved any probiotic product for use as a drug or biological product in infants,” the letter noted. “The FDA is aware that some unapproved, unlicensed probiotics are nonetheless sold for use to treat or prevent a disease or condition in infants.”
The American Academy of Pediatrics does not support the use of probiotics in preterm infants because of conflicting data on their safety.
Two products — Abbott’s Similac Probiotic Tri-Blend and Infinant Health’s Evivo with MCT Oil — have been classified by the FDA as “unapproved new drugs and unlicensed biological products.”
Last year, Abbott came under fire for potentially contaminated formula products that ultimately triggered a national infant formula shortage. According to the FDA’s warning letter, the company was marketing its probiotic product (which is not an infant formula) directly to hospital staff, and selling it for use in preterm infants.
The Abbott probiotic ingredients Bifidobacterium infantis and Streptococcus thermophilus are, respectively, classified by the regulator as “an unsafe food additive” and a “new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”
The FDA noted that an infographic from Abbott “acknowledges that the ‘gut is not fully developed’ in many preterm infants and nonetheless recommends [the] product be administered to this population because probiotics ‘increase the number of good bacteria in the gut, promoting a healthy microbiome.'”
The Infinant product, Evivo with MCT Oil, contains the ingredient Bifidobacterium longum subspecies infantis. In their letter, the FDA noted that the probiotic is an adulterated food because it contains this ingredient, which is considered an unsafe food additive.
Infinant’s website states that their probiotic product is intended to be added to infant food, and according to a product information sheet, is designed specifically for infants in the neonatal intensive care unit.
In a meeting with the FDA in July, the company presented clinical studies supporting its claims about the benefits of their product, which the agency called “short-term, poorly designed, and difficult to interpret without appropriate controls.”
Abbott discontinued the sale of its Similac Probiotic Tri-Blend product and is working on “additional corrective actions,” according to the FDA. Abbott did not respond to a request for comment in time for publication.
Infinant has voluntarily recalled and discontinued its Evivo with MCT Oil product, a spokesperson for Infinant Health wrote in a statement sent to MedPage Today.
The Class II recall, according to the company, means that “use of the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.” Infinant said it will “continue to cooperate with the FDA in its investigation.”
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Sophie Putka is an enterprise and investigative writer for MedPage Today. Her work has appeared in the Wall Street Journal, Discover, Business Insider, Inverse, Cannabis Wire, and more. She joined MedPage Today in August of 2021. Follow
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