After 2 Deaths, FDA Warns Not to Feed SimplyThick to Premature Babies

A product used to help premature babies swallow their food has been linked to the deaths of two infants, the Food and Drug Administration warns.

SimplyThick, a thickening agent mixed with breast milk and baby formula to prevent spitting up, has been reported to cause necrotizing enterocolitis or NEC, which involves inflammation of intestinal tissue. As a result, the FDA now says it should not be given to premature infants still in the hospital or those sent home within the past 30 days.

The product, also used by older children and adults with swallowing problems, is sold in individual packets and half-gallon bottles by distributors and pharmacies around the country.

The dangers of SimplyThick surfaced earlier this month when two doctors filed reports with the FDA. Since then the agency has heard from at least four medical centers reporting infants getting sick over the past six months.

To date, the agency is aware of 15 cases of NEC, including the two deaths, involving premature infants given the product. The FDA still is trying to find out what about SimplyThick is making babies ill.

Signs and symptoms to watch for include bloated stomach, greenish-tinted vomiting and bloody stools. But the FDA says parents should stop giving the product to premature infants, those whose gestation periods were less than 37 weeks, even if they don’t show any symptoms.

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