The U.S. Food and Drug Administration today expanded a recall on a product called SimplyThick.
The agency 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 the product that 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.
Since May 2011, the FDA has identified 22 infants who developed necrotizing enterocolitis, a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick.
Seven of those infants died.
Further study is needed to determine if there is an actual link between consumption of SimplyThick and the development of the illness, officials said.
SimplyThick is 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 bought from distributors and local pharmacies throughout the U.S.
The FDA first learned of bad side effects possibly linked to SimplyThick on May 13, 2011.
The FDA said signs of necrotizing enterocolitis to look for include bloated stomach, greenish-tinged vomiting and bloody stools. Parents are urged to contact their health care provider if their child has any of the symptoms or if the parent has concerns related to using SimplyThick.