New Delhi: The US Food and Drug Administration is cautioning healthcare providers and the public about injuries and at least one fatality in premature infants who were administered probiotic products in the hospital.
The products, which supplement regular feeding and contain live microorganisms such as bacteria or yeast, can lead to invasive, potentially lethal infections or diseases, stated the FDA on Thursday.
The supplements may be linked to one death this year and over two dozen reports of injuries since 2018, according to FDA officials. The agency also stated that it is investigating additional reports of injuries and fatalities.
No probiotic products have been authorized as medications or treatments for infants, according to the FDA.
The agency has issued warning letters to two companies accused of illegally marketing probiotic products, including Abbott Laboratories, which was involved in a recall and a nationwide shortage of powdered infant formula last year. After receiving a letter on Tuesday, the Illinois-based company agreed to discontinue sales of its Similac Probiotic Tri-Blend product and collaborate with the FDA on further corrective actions, as per the agency’s announcement.
Abbott officials stated in a statement that the products were utilized in fewer than 200 hospitals and are not related to Similac powdered infant formulas sold in retail stores.
In September, FDA officials mentioned that Evivo with MCT Oil, a probiotic manufactured by Infinant Health of Norwalk, Connecticut, was responsible for the death of a premature infant this year. Genetic sequencing confirmed that the bacterium causing sepsis was the same microorganism found in the probiotic product.
Infinant Health officials declared in a statement that the company voluntarily recalled and discontinued the product. The product was exclusively sold for use in hospital settings and is not connected to products available in retail stores.
Probiotic supplements may be utilized to prevent necrotizing enterocolitis, a dangerous infection that affects premature infants and causes inflammation and death of intestinal tissue. The condition affects up to 9,000 infants annually, with a mortality rate of approximately 50 per cent.
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