SimplyThick Manufacturer Changes Product Warnings in Light of Potential Catastrophic Infant Injury or Death

Last month, SimplyThick, LLC, the manufacturer of SimplyThick, announced online a major change to its product warnings. The new warning will state that SimplyThick is “NOT intended for use with preterm or infants under 12 months of age. Or children under the age of 12 years with a history of NEC.” This action follows two advisories by the U.S. Federal Drug Administration (“FDA”) that infant’s fed SimplyThick may develop necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, which if not catastrophic, can be fatal.

In May 2011, the FDA advised against feeding SimplyThick to infants born before 37 weeks gestation because it could cause necrotizing enterocolitis (NEC). In September 2012, the FDA expanded its warning to all infants under the age of 12 months as being a dangerous product.

After the May 2011 SimplyThick warning, the FDA began investigating the possible relationship between SimplyThick and NEC in all cases reported between 2008 and 2011. The FDA’s researchers found that 22 infants developed NEC, a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died.

Prior to the first FDA warning in 2011, SimplyThick, LLC, promoted the product for use in infant formula and breast milk in order to assist infants in swallowing. The company conducted no clinical tests on the safety and effectiveness of SimplyThick when fed to infants in breast milk or infant formula.

SimplyThick, created by SimplyThick, LLC, and manufactured by Thermo Pac, LLC, in Stone Mountain, Georgia, is a thickening agent in the form of a gel that parents can mix with breast milk or formula. It’s intended to ease infants’ swallowing difficulties and help them keep their food down. The product is also used in older children and adults with swallowing problems caused by trauma to the throat.

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