FDA Warns Abbott, Infinant Health About Selling Preterm Infant Probiotic Products

By Dean Seal

The Food and Drug Administration has warned Abbott Laboratories and Infinant Health they are illegally selling probiotic products that aren't approved for preterm infants.

The regulator said Thursday it is advising healthcare providers about the possible risks that probiotic products, or ones containing live bacteria or yeast, post to preterm infants in hospital settings.

These products can be dangerous for preterm infants, the FDA said, noting that there has been one infant death reported this year from a probiotic product being used in a hospital setting to prevent necrotizing enterocolitis.

The agency said it hasn't approved any probiotic product for use as a drug or biological product in infants of any age, and is therefore reaching out to Abbott and Infinant about some of their products.

The letter to Abbott, sent Tuesday, targets the company's Similac Probiotic Tri-Blend. The FDA said Abbott has agreed to discontinue sales of the product and work with the agency on further corrective actions.

The FDA is warning Infinant about its probiotic product, Evivo with MCT Oil, being sold to treat or prevent disease in preterm infants. The product has since been voluntarily recalled and isn't available in the U.S. anymore.

Write to Dean Seal at [e-mail]

(END) Dow Jones Newswires

October 26, 2023 12:40 ET (16:40 GMT)

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