The Food and Drug Administration is warning health care providers and the public about injuries and at least one death in premature infants who were given probiotic products in the hospital.
The products, which supplement regular feeding and contain live organisms such as bacteria or yeast, can lead to invasive, potentially fatal infections or disease, the FDA said Thursday.
One death this year and more than two dozen reports of injuries since 2018 may be tied to the supplements, FDA officials said in a statement. The agency said it is also investigating additional reports of injuries and deaths.
No probiotic products have been approved as a drug or treatment for babies, the FDA said.
The agency issued warning letters to two companies accused of illegally marketing the probiotics products, including Abbott Laboratories, which was at the center of a recall and nationwide shortage of powdered infant formula last year. After a letter sent Tuesday, the Illinois firm agreed to halt sales of its Similac Probiotic Tri-Blend product and work with the FDA on additional corrective actions, the agency said.
Abbott officials said in a statement that the products were used by fewer than 200 hospitals and are not related to Similac powdered infant formulas sold in stores.
FDA officials in September said Evivo with MCT Oil, a probiotic made by Infinant Health of Norwalk, Connecticut, led to the death of a premature infant this year. Genetic sequencing confirmed that the bacterium that caused sepsis was the same germ found in the probiotic product.
Infinant Health officials said in statement that the firm voluntarily recalled and discontinued the product. It was sold only for use in hospital settings and is not related to products available in retail stores.
Probiotic supplements may be used to prevent necrotizing enterocolitis, a dangerous infection affecting premature infants that inflames and kills intestinal tissue. The condition affects up to 9,000 infants a year, with a death rate of about 50%.