FDA Warns Against Probiotics for Premature Babies

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The administration of probiotic products to premature babies may lead to serious health risks that can be life-threatening.

The U.S. Food and Drug Administration (FDA) is warning against using probiotic products for preterm infants following the death of a baby who was given probiotics in a hospital, per an October 26 FDA news release.

There have been over two dozen other reports of adverse events associated with infants given probiotic products in the United States since 2018.

“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 release states.

It is crucial to note that probiotic products not approved or licensed by the FDA have not undergone the rigorous standards of manufacturing and testing established by the agency. Furthermore, the FDA has not authorized probiotic products as drugs or biological products for infants of any age.

The FDA has issued a letter of warning to healthcare providers regarding the dangers of administering probiotic products to infants. In the letter, the FDA reminds healthcare providers administering probiotics with live bacteria or yeast to submit an Investigational New Drug Application if these products are used to “treat, mitigate, cure, or prevent a disease or condition.”

Additionally, the FDA sent two warning letters to companies for selling such products illegally “to treat or prevent certain diseases in preterm infants,” the release notes.

The warning letters were sent to Infinant Health and Abbott Laboratories.

The FDA noted that “a preterm infant, birthweight <1000 g, who was administered a probiotic, Evivo with MCT Oil (Infinant Health), as part of in-hospital care, developed sepsis caused by the bacterium Bifidobacterium longum and subsequently died.”

The FDA is investigating the death, and the product has been recalled.

On October 24, Abbott Laboratories received a warning letter from the FDA for the product Similac Probiotic Tri-Blend, which contains B. infantis (Bb-02), S. thermophilus (TH-4), and B. lactis (BB-12). According to the warning letter, Abbott sells the product specifically for hospital use in caring for preterm infants.

Similac Probiotic Tri-Blend is a “new drug and an unlicensed biological product being sold in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act,” the news release reads.

In response, Abbott agreed to discontinue the sale of Similac Probiotic Tri-Blend. The company is working with the FDA to take additional corrective measures.

“This issue pertains to a single probiotic additive for formula called Similac Probiotic Tri-Blend, which fewer than 200 hospitals use,” a spokesperson for Abbott told CBS News Texas.

“Importantly, this does not apply to any of Abbott’s infant formula products available at retail, and parents and caregivers can continue to find and use Similac infant formulas nationwide, the spokesperson said.

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