Med Mal News

Health care facilities that use the thickening product SimplyThick in infant formula intended for premature babies are being warned to discontinue the practice following reports to the U.S. Food and Drug Administration (FDA) that the product could cause a life-threatening condition known as necrotizing enterocolitis (NEC) in babies born prematurely. Reports that babies were contracting NEC, which is characterized by inflammation and death of intestinal tissue, began coming into the FDA in mid-May. Four medical centers around the country were affected. As of May 20, when the agency began warning parents and health care providers of the danger, 15 cases of NEC in premature infants given formula or breast milk mixed with SimplyThick had been identified, including two fatalities. “The current situation is unusual because NEC most often occurs in babies within the hospital early in their premature course,” the FDA stated in its announcement. “But among the ill babies of which FDA is aware, some had been discharged from the hospital to home on a feeding regimen that included SimplyThick and then fell ill at home.” Symptoms of NEC, which can occur in premature infants even several months old, include abdominal bloating, green-tinged vomiting, feeding intolerance and bloody stools.