Do not feed SimplyThick to premature infants

 

The Food and Drug Administration (FDA) warned parents, caregivers, and healthcare providers to not feed SimplyThick to infants born before 37 weeks of pregnancy. SimplyThick is a thickening agent that is used to thicken liquids for adults or infants with swallowing problems.

It was determined that this product may cause necrotizing enterocolitis (NEC) in very young infants. NEC is a life-threatening condition that causes tissue in the intestines to become irritated and die. FDA first learned about this adverse side effect and its link to SimplyThick on May 13, 2011. The condition had been reported from at least four different medical centers around the country. FDA is aware of 15 cases of NEC in young babies fed SimplyThick for varying amounts of time. Two of the babies died. SimplyThick had been mixed with breast milk or infant formula. Healthcare providers, parents, and caregivers should avoid administering the product to pre-mature infants. Parents and care-givers should contact their infant's doctor if they have questions or concerns. For additional details, visit the FDA Safety Alert.

Created on November 22, 2011