FDA Expands Caution About SimplyThick

FDA wants parents, caregivers and health care professionals to be aware that infants of any age may face an increased risk of developing a life-threatening condition if fed a thickening product called SimplyThick.

The agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants have died.

FDA had issued an advisory in May 2011 that warned of the risk to infants born prematurely. Now, FDA is extending that advice to include infants on any age.

SimplyThick is a brand of thickening agent—available to consumers and medical centers—to help manage swallowing difficulties.