Parents and caregivers have been warned by the US Food and Drug Administration (FDA) not to add thickening agent SimplyThick to infant formula and breastmilk for premature babies.
The warning came after the FDA became aware of more than a dozen occurrences of a potentially life-threatening side effect linked with the product, and two deaths. SimplyThick, sold at health centers and pharmacies, is added to formula or breastmilk for babies who have experienced difficulty swallowing. The FDA cautions parents that the product could cause “necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and dies” in which part of the intestine “becomes inflamed and dies.”
The FDA explains that the product is administered to infants and children who have difficulty swallowing and keeping food down, and that the reason behind the link is unknown:
This situation is unusual because NEC most often occurs in babies while they are in the hospital early in their premature course. But some of the ill babies that FDA is aware of got sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.
At this time it is not known what about SimplyThick is making babies sick. FDA is actively investigating the link between SimplyThick and these illnesses and deaths.
The FDA has advised parents to stop using SimplyThick even if their baby does not appear to be sick.