In its announcement* the FDA said that since May 2011, the agency has identified 22 infants who developed NEC, a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died.
The agency said that further study is needed to determine if there is an actual link between consumption of SimplyThick and the development of NEC and that the results of that research will be announced to the public and health care professionals.
“But, 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 agency said.
The FDA described SimplyThick as a brand of thickening agent—available to consumers and medical centers—used to help manage swallowing difficulties.
It is sold in individual serving packets as well as in 64-ounce dispenser bottles, which can be purchased from distributors and local pharmacies throughout the United States.
The agency said Benson M. Silverman, M.D., director of FDA's Infant Formula and Medical Foods Staff—himself a neonatologist—explained that 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.
The product is also used in older children and adults with swallowing problems caused by trauma to the throat, he said.
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