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FDA Issues Alert: Do not feed SimplyThick to premature infants


An FDA alert advises parents, caregivers and health care providers not to feed premature infants SimplyThick as it may cause necrotizing enterocolitis (NEC), a life-threatening condition.

To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The agency first learned of adverse events possibly linked to the SimplyThick on May 13, 2011.

SimplyThick is a thickening agent for management of swallowing disorders (dysphagia) in all age groups. The thickening agent in SimplyThick® brand thickener is xanthan gum. Xanthan gum is a complex carbohydrate that acts as soluble food fiber and passes through the body essentially without being digested.

SmiplyThick is used by mixing it with the mothers’ breast milk or infant formula products. The FDA alert is only for premature infants less than 37 weeks of age.

The 15 reported illnesses in premature infants involve at least four different medical centers around the country over the past six months. All of the premature infants had swallowing difficulties (dysphagia) related to their prematurity. As part of the treatment, all had SimplyThick added to the feeding regimen of those infants who later developed NEC to help with swallowing in an attempt to help the swallowing issue.

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Necrotizing enterocolitis (NEC) is the death of intestinal tissue. The cause for this disorder is unknown, but it is thought that a decrease in blood flow to the bowel keeps the bowel from producing mucus that protects the gastrointestinal tract. Bacteria in the intestine may also be a cause.

NEC primarily affects premature infants or sick newborns and most often develops while the infant is still in the hospital. The FDA reports some of the cases of NEC linked to SimplyThick have occurred in infants who have been discharged from the hospital to home on a feeding regimen that included SimplyThick and then fell ill at home.

Signs and symptoms of NEC include appearance of a bloated abdominal area, appearance of illness, feeding intolerance, greenish-tinged (bile) vomiting and bloody stools. Seek immediate medical attention if any of these are noted in an infant, especially a premature infant.

SimplyThick is one brand of thickening agent available to medical centers and consumers. The product is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.

Images of the SimplyThick label and packaging can be viewed here.

Image Credit

Food and Drug Administration
PubMed Health -- Necrotizing Enterocolitis