The Abbott Laboratories logo is displayed on a screen at the New York Stock Exchange (NYSE) in New York City, United States, October 18, 2021. Portal/Brendan McDermid/File Photo Acquire License Rights
Oct 26 (Portal) – Abbott Laboratories (ABT.N) will stop selling its Similac Probiotic Tri-Blend product for hospitalized premature babies after the U.S. Food and Drug Administration issued a warning letter, the health agency said on Thursday .
In the letter, the FDA said it was concerned that premature babies were at risk of potentially fatal diseases or infections caused by bacteria or yeast contained in the probiotics.
“The product is an unapproved new drug and an unlicensed biologic product that is being sold in violation of the regulations,” the FDA said Thursday of Abbott’s Similac probiotic product.
The agency issued a similar warning to California-based Infinant Health in September.
Infinant’s product, sold under the Evivo brand with MCT oil, has since been voluntarily recalled and is no longer available in the country, the FDA said.
Abbott and Infinant did not immediately respond to requests for comment.
One infant death was reported in 2023, and more than two dozen additional adverse events related to probiotic products have been reported in the U.S. so far since 2018, the agency said.
The FDA is also investigating reports that these products may have contributed to additional adverse events, including deaths, and is working to obtain evidence and medical records.
Certain probiotic products used in hospitals to prevent a life-threatening bacterial disease have contributed to invasive disease, the agency said.
The warning letter is different from the baby formula issue last year, the FDA said, and relates to the closure of the Abbott plant in Michigan following a recall of some products due to bacterial contamination.
Reporting by Leroy Leo in Bengaluru; Editing by Shinjini Ganguli and Sriraj Kalluvila
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