SimplyThick, a brand of food thickening agent, may increase the risk of developing Necrotizing Enterocolitis or "NEC" in infants, a potentially fatal disease. Simply Thick was added to breast milk and infant's formula to help premature babies swallow their food without spitting up. It has also been used since 2001 by adults who have difficulty swallowing. NEC is a very serious condition in which the intestine becomes inflamed and eventually dies. Approximately one quarter of babies who develop NEC die of the condition.
By the time the FDA declared SimplyThick unsafe for all infants in 2012, more than 20 infants had developed NEC. The product remains on the market for use by adults. Pre-term or infants under 12 months of age should not use SimplyThick. Children under 12 with a history of NEC should not use SimplyThick.
Parents of the affected infants are filing suit against SimplyThick for wrongful death and lifelong injuries. Over 20 lawsuits have been filed. The suits allege that SimplyThick did not appropriately test, study, or market the product, did not warn parents or the medical community about potential risks, and continued to market SimplyThick by providing untrue statements about its safety.
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