The Food and Drug Administration (FDA) is warning parents, caregivers and health care professionals that infants – regardless of age – who are fed SimplyThick thickening product may face an increased risk of developing necrotizing enterocolitis (NEC), a potentially deadly condition in which tissue in the intestines becomes inflamed and dies.

Since May 2011, the FDA has identified 22 infants who developed NEC after being fed SimplyThick. Seven of those infants died. All but one of the infants had been born prematurely. Half of the infants developed the condition in the hospital, and half developed it after being sent home.

SimplyThick is a brand of thickening agent available to consumers and medical centers that is used to help manage swallowing difficulties. It is added to breast milk or infant formula to help premature babies swallow their food and keep it down without spitting up. It is also used in older children and adults with swallowing problems caused by trauma to the throat.

The FDA says that further study is needed to determine if there is an actual link between the consumption of SimplyThick and the development of NEC. In the interim, the FDA wants anyone caring for an infant to be aware of the potential risk before deciding whether to feed SimplyThick to infants of any age.

Anyone caring for an infant who is feeding SimplyThick should watch for symptoms of NEC, including a bloated stomach, greenish-tinged vomiting, and bloody stools, and seek medical attention immediately if symptoms are present.

Any side effects related to SimplyThick should be reported to the FDA Medwatch Adverse Event Reporting Program at www.FDA.gov/Medwatch/Report.htm.

Source: FDA

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