The FDA issues a caution against administering probiotics to premature infants following the death of one baby and other reported injuries.

The U.S. Food and Drug Administration has issued a cautionary message to healthcare professionals and the general public regarding harm and even a fatality in preterm babies who received probiotic products during their hospital stay.

According to the FDA, products that add live organisms like bacteria or yeast to regular feeding may cause dangerous infections or diseases, potentially leading to death. This statement was made on Thursday.

According to a statement from FDA officials, there have been reports of one death and over 24 injuries possibly linked to supplements this year, as well as since 2018. The agency is currently looking into other reports of injuries and deaths related to these supplements.

The FDA stated that no probiotic products have been authorized as medication or therapy for infants.

The FDA sent warning letters to two companies that were allegedly promoting probiotics products in violation of the law. One of these companies, Abbott Laboratories, was involved in a recall and shortage of powdered infant formula last year. After receiving a letter on Tuesday, the Illinois-based company agreed to stop selling their Similac Probiotic Tri-Blend product and collaborate with the FDA to take necessary corrective actions.

According to a statement from Abbott, the products were utilized by less than 200 hospitals and are not associated with the Similac powdered infant formulas available in stores.

In September, representatives from the FDA reported that the use of Evivo with MCT Oil, a probiotic produced by Infinant Health in Norwalk, Connecticut, resulted in the death of a prematurely born baby earlier this year. After conducting genetic sequencing, it was determined that the bacteria responsible for causing sepsis was identical to the one found in the probiotic.

The company, Infinant Health, issued a statement stating that they are voluntarily recalling and discontinuing their product. The product was only sold for use in hospitals and is not connected to any products sold in retail stores.

Probiotic supplements can potentially be utilized as a preventative measure against necrotizing enterocolitis, a life-threatening infection that causes inflammation and tissue death in premature infants. This condition impacts approximately 9,000 infants annually and has a mortality rate of around 50%.


This report was contributed to by Matthew Perrone, a health writer based in Washington.


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