The US Food and Drug Administration warns against the use of probiotic products for premature babies due to potentially fatal health risks. The news comes weeks after the agency announced it was investigating the death of a premature baby who was given a probiotic at the hospital, which ultimately led to the child’s death.
“Probiotic products contain living organisms such as bacteria or yeast and are commonly marketed as foods, including dietary supplements,” the agency said in a news release Thursday.
The FDA said premature babies given probiotics are at risk of “invasive, potentially fatal disease or infection caused by the bacteria or yeast contained in the products.”
In addition to recently sending a letter to healthcare providers about these risks, the agency also issued two warning letters to companies that illegally sell these types of products.
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“Adverse events in any infant following the use of a probiotic are of concern to the FDA. “We particularly want to make it clear that products containing live microorganisms can pose serious risks to premature babies in hospitals,” says Dr. Peter Marks, Director of the FDA The FDA’s Center for Biologics Evaluation and Research said in the press release.
“Today’s message is to warn parents, caregivers and healthcare providers that when these products are used to prevent or treat disease, they have not been subjected to the agency’s rigorous premarket process to assess their safety, effectiveness and quality for these medical uses. “” Marks said.
The FDA says these products have been linked to “more than two dozen other reported adverse events in the United States” since 2018.
The latest death occurred after using Evivo with MCT oil, a probiotic manufactured by California-based Infinant Health (formerly Evolve BioSystems Inc.). The product is now being recalled.
Infinant Health, Inc. received one of the FDA warning letters; the other was sent to Abbott Laboratories on Tuesday for its Similac Probiotic Tri-Blend product.
“Abbott has agreed to discontinue sales of its Similac Probiotic Tri-Blend product and is working with the FDA to take additional corrective action,” the FDA press release said.
The FDA previously noted that no probiotics are approved for use as a drug or biologic product in babies, meaning probiotics are not subject to the agency’s “strict manufacturing and testing standards” for other FDA-regulated drugs.
Probiotics are allowed to be sold as dietary supplements in the United States, bypassing the FDA’s higher requirements for drug and biologic approval.
-Alexander Tin contributed to this report.