Seven babies died after being fed an additive used to help thicken infant formula or breast milk, U.S. regulators said.
The deaths were among 21 premature infants and one born full-term that developed inflamed intestines after they were given SimplyThick, the Food and Drug Administration said in a consumer update today. The product is a thickening gel designed to help premature babies swallow food and keep it down, said Benson Silverman, director of FDA’s Infant Formula and Medical Foods Staff.
The agency first warned in May 2011 against feeding SimplyThick to premature babies because it may cause a tissue inflammation known as necrotizing enterocolitis. The FDA is expanding the warning today to infants of all ages. Further study is needed to determine if a link between SimplyThick and the condition exists, FDA said.
The product, made by the company SimplyThick LLC of St. Louis, is available to consumers and at medical centers, according to the FDA. It is sold in individual serving packets and in 64-ounce dispenser bottles, which can be purchased from distributors and pharmacies. A phone message left at SimplyThick wasn’t returned.
Older children and adults use the product to help with swallowing problems caused by trauma to the throat, Silverman said in the update.