Two of the babies died after being fed the product with milk or infant formula.
The product consists of xanthan gum, potassium sorbate, citric acid, and water and is sold to make liquids easier to swallow for dysphagic patients. It was not recalled, and there is currently no indication of any danger to anyone other than infants of less than 37 weeks' gestation.
Its manufacturer, SimplyThick of St. Louis, does not appear to have specifically marketed the product for use in premature newborns. But some parents and healthcare personnel have evidently given it to such infants, who often have difficulty swallowing breast milk or formula.
The FDA said the necrotizing enterocolitis cases occurred in "at least four different medical centers around the country" during the past six months, although it did not become aware of them until May 13.
Newborns had been fed the product for various durations. "The current situation is unusual because necrotizing enterocolitis most often occurs in babies within the hospital early in their premature course," the agency said.
"But among the ill babies of which FDA is aware, some had been discharged from the hospital to home on a feeding regimen that included SimplyThick and then fell ill at home."
The agency has not definitely concluded that the product was responsible for the illnesses. It indicated the link was being investigated, and it promised to provide updates as more information becomes available.
The manufacturer posted a statement acknowledging the necrotizing enterocolitis reports on its website's home page, which said the company was conducting its own inquiry.
"Pending the conclusion of the investigations, we are telling our customers and medical professionals to follow the FDA's recommendation that SimplyThick brand thickener not be used with or given to babies who were born before 37 weeks," the company said.
The product is sold in single-serving packets and 64-ounce dispensers.
medpagetoday