FDA Warns of Probiotic Product Risks in Premature Infants
According to the reports in the media, the U.S. Food and Drug Administration (FDA) is issuing a caution to healthcare providers and the public regarding injuries and, in one instance, the death of premature infants who received probiotic products while in the hospital. These products, which are meant to supplement regular feeding and contain live organisms like bacteria or yeast, have the potential to cause invasive and possibly fatal infections or diseases, as stated by the FDA on Thursday.
Reportedly, according to FDA officials,since 2018, there have been more than two dozen reports of injuries and one death this year that may be linked to these supplements. The agency is currently investigating additional reports of injuries and deaths. It is important to note that no probiotic products have received FDA approval as drugs or treatments for infants, the media report stated.
The FDA has sent warning letters to two companies accused of unlawfully marketing these probiotic products, including Abbott Laboratories, which was involved in a recall and nationwide shortage of powdered infant formula last year. After receiving a letter earlier this week, the Illinois-based company has agreed to cease the sale of its Similac Probiotic Tri-Blend product and collaborate with the FDA on additional corrective actions.
The reports in the media stated that Abbott has clarified that these products were used in fewer than 200 hospitals and are not associated with Similac powdered infant formulas sold in stores. Previously, FDA officials stated that Evivo with MCT Oil, a probiotic manufactured by Infinant Health of Norwalk, Connecticut, was linked to the death of a premature infant earlier this year. Genetic sequencing confirmed that the bacterium responsible for sepsis was the same as the one found in the probiotic product.
Infinant Health stated that the company voluntarily recalled and discontinued the product, which was intended for use exclusively in hospital settings and is not connected to products available in retail stores. Probiotic supplements may be used to prevent necrotising enterocolitis, a dangerous infection that affects premature infants, causing inflammation and damage to intestinal tissue affecting around 9,000 infants each year, with a mortality rate of approximately 50 per cent.
