The FDA is cautioning caregivers and clinicians that SimplyThick — a thickening agent used to manage swallowing disorders — may cause necrotizing enterocolitis in infants born at any gestational age. Previously, the agency warned against giving SimplyThick to infants born before 37 weeks.

Since May 2011, 22 infants have developed necrotizing enterocolitis after being fed SimplyThick. One of these infants was born at term. The agency says that further study is needed to determine whether there is an actual association between use of the thickening agent and enterocolitis.

Source: FDA