The Food and Drug Administration says the thickening product SimplyThick should not be mixed with breast milk or infant formula and given to babies because it may raise the risk of a life-threatening condition, necrotizing enterocolitis. It is marked by inflammation and death of intestinal tissue.
The new warning extends a previous one stating that SimplyThick should not be given to premature babies.
Twenty-two infants have developed intestinal problems because of SimplyThick. Of those, seven have died.
The FDA says further study is needed to determine if there is an actual link between SimplyThick and developing necrotizing enterocolitis.
SimplyThick is a brand of thickening agent used to help manage swallowing difficulties. It had been used to help premature babies swallow their food and keep it down.