USA — In a recent advisory, the U.S. Food and Drug Administration (FDA) has expressed growing apprehension regarding the safety of probiotic products administered to premature infants in healthcare settings.
This heightened concern is primarily due to the FDA’s acknowledgment of the potential for invasive and potentially life-threatening infections associated with these supplements, underscored by reported cases of injuries and even one tragic fatality.
The FDA’s response to this emerging issue has taken the form of a comprehensive warning, aiming to acquaint both healthcare providers and the general public about the associated risks when utilizing probiotic products in the care of premature infants.
These products, which contain live microorganisms such as bacteria or yeast and are typically administered alongside regular feeding, have been associated with severe infections and diseases.
FDA officials have reported one infant death this year, along with over two dozen injury cases dating back to 2018 that may be linked to the use of probiotic supplements.
The FDA is actively investigating additional incidents of injuries and fatalities associated with these products.
It is essential to note that no probiotic products have received FDA approval for use as a drug or treatment for infants.
Warning letters and marketed probiotic products
As a response to the potential risks, the FDA has issued warning letters to two companies accused of unlawfully marketing probiotic products for infants.
Among these companies is Abbott Laboratories, which previously faced a recall and nationwide shortage of powdered infant formula.
Following the FDA’s warning letter, Abbott agreed to discontinue sales of its Similac Probiotic Tri-Blend product and collaborate with the agency on corrective actions.
Abbott officials have clarified that the affected products were used by fewer than 200 hospitals and are distinct from Similac powdered infant formulas available in retail stores.
Probiotic-related infant fatality and recall
In a separate incident earlier this year, FDA officials linked the death of a premature infant to Evivo with MCT Oil, a probiotic product manufactured by Infinant Health, based in Norwalk, Connecticut.
Genetic sequencing revealed that the bacterium causing sepsis in the infant was identical to the one found in the probiotic product.
In response, Infinant Health voluntarily recalled and discontinued the product, emphasizing that it was exclusively intended for use in hospital settings and not associated with probiotic products available in retail stores.
Probiotics and necrotizing enterocolitis
Probiotic supplements are often administered to prevent necrotizing enterocolitis, a severe and life-threatening infection that primarily affects premature infants, leading to inflammation and tissue death in the intestines.
This condition afflicts up to 9,000 infants annually and has a mortality rate of approximately 50%.
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