The U.S. Food and Drug Administration (FDA) has raised concerns regarding the utilization of probiotic products in premature infants, following a series of reported injuries and, tragically, a fatality this year. These supplements, intended to augment regular feeding, comprise live organisms like bacteria or yeast. When administered to delicate infants, they can potentially lead to severe and even fatal infections and ailments. The FDA has initiated thorough investigations to ascertain the full extent of this issue, urging both healthcare providers and the public to exercise utmost caution.
According to an official statement by FDA authorities, one infant’s demise this year, coupled with over twenty-five reported injuries since 2018, may be attributed to the use of these probiotic products. The agency has also disclosed that they are actively reviewing additional reports of injuries and fatalities linked to these supplements. In response to this alarming trend, the FDA has taken swift action by issuing warning letters to two companies, including the reputable Abbott Laboratories, accused of unlawfully marketing probiotic products.
Abbott Laboratories, known for a recall and nationwide shortage of powdered infant formula last year, has committed to collaborating with the FDA. Subsequent to receiving the FDA’s letter on Tuesday, the Illinois-based company has opted to cease the sales of its Similac Probiotic Tri-Blend product. They have further pledged to work in close conjunction with the FDA to implement additional corrective measures.
In an official statement addressing the matter, Abbott officials have clarified that the products in question were exclusively utilized by fewer than 200 hospitals and hold no relation to the Similac powdered infant formulas available for purchase in retail stores.
The FDA’s scrutiny of probiotic products is not unprecedented. In September, the FDA reported an incident involving Evivo with MCT Oil, a probiotic product produced by Infinant Health of Norwalk, Connecticut, which led to the unfortunate passing of a premature infant earlier this year. The results of genetic sequencing left no room for doubt: the bacterium responsible for sepsis in the infant was identical to the strain found in the probiotic product.
In response to these findings, Infinant Health took prompt and responsible action by voluntarily recalling and discontinuing the product. It is imperative to note that this particular product was exclusively distributed for use within hospital settings and holds no affiliation with probiotic products available for purchase in retail outlets.
The FDA’s measures are oriented towards safeguarding the well-being of premature infants, who are particularly susceptible to infections and complications. As the investigations progress, it is crucial for healthcare providers and the general public to be cognizant of the potential risks associated with probiotic products, and to exercise utmost caution when administering them to premature infants.