Infant Deaths lead to FDA Warning on use of SimplyThick with Baby Formula and Breast Milk

Seven infants who recently died were among 22 infants who, since May of 2011, have been identified as developing necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed baby formula or breast milk mixed with SimplyThick. In response, the Food and Drug Administration (FDA) has issued a warning on the use of SimplyThick.

The recent warning from the FDA expands on an earlier warning for use of the product on premature infants, and now includes infants of any age. The warning cites an increased risk for developing the life-threatening condition after feeding on formula or breast milk mixed with the thickening agent.

According to the FDA’s director of Infant Formula and Medical Foods Staff, Benson M. Silverman, M.D., SimplyThick is a brand of thickening agent which is often used to help manage swallowing difficulties. The thickening agent is added to breast milk and infants’ formula to help the premature babies swallow their food and keep it down, without spitting up and has also been used in older children and adults with swallowing problems caused by trauma to the throat.

While the agency reported that further study will be required to establish a definitive link between consumption of SimplyThick and the development of NEC, the FDA “wants everyone involved in the care of a baby to be aware of the potential risk before deciding whether to feed SimplyThick to infants of any age.”

The FDA warning includes the Symptoms to Watch for when dealing with SimplyThick and the potential for necrotizing enterocolitis (NEC). The symptoms include, bloated stomach, greenish-tinged vomiting and bloody stools. The agency warns to contact your health care professional if your baby has any of the symptoms or if you have other concerns related to using SimplyThick.