Don’t use SimplyThick in premature infants, the FDA warns

The Food and Drug Administration on Friday warned parents and physicians against giving the thickening agent SimplyThick to premature infants. The product is frequently added to thin foods, such as breast milk or infant formula, to make them easier to ingest for people who have swallowing difficulties. But the agency said it has recently received 15 reports of infants who received the product developing necrotizing enterocolitis, with two deaths.

Necrotizing enterocolitis is a life-threatening condition characterized by inflammation and the death of intestinal tissue. It is most often diagnosed in babies who are born prematurely, particularly infants still in the hospital. Most of the reports received by the FDA, however, were among infants who had been discharged.

Symptoms of the disorder include the appearance of a bloated abdominal area, the appearance of illness, feeding intolerance, greenish-tinged vomiting and bloody stools.

Premature infants still in the hospital and those who have been discharged within the past 30 days should not be given SimplyThick, the agency said. Any problems observed in infants who have received it should be reported to the agency.

SimplyThick is manufactured by SimplyThick LLC of St. Louis, Mo. It is sold in packets of individual servings and 64-ounce dispenser bottles.