SimplyThick, a thickening agent to help manage swallowing difficulties, should not be given to premature infants because it can cause life-threatening necrotizing enterocolitis (NEC), the Food and Drug Administration (FDA) warns.
The product can cause inflammation in tissue in the intestines of some infants - the tissue eventually dies.
SimplyThick is purchased by medical centers and consumers and comes in packets of individual servings as well as in 64-ounce dispenser bottles.
The product is added to premature infants' formula to help them swallow their food and prevent them from spitting it back up. SimplyThick is also used with older patients who have swallowing problems.
Director of FDA's Infant Formula and Medical Foods Staff, neonatologist, Dr. Benson Silverman received two reports on May 13 this year of cases of necrotizing enterocolitis linked to SimplyThick in premature infants. He followed up with the doctors who reported the cases and then inquired with a network of neonatologists.
The severity and scope of the problem soon became clear. The FDA now knows of 15 cases of NEC in premature babies, two of whom died. SimplyThick was mixed with formula or mother's milk and given to the infants for varying amounts of time.
Four medical centers in different parts of the USA have reported adverse events in infants over the last six months.
NEC tends to develop while the premature baby is still in hospital. However, some of these babies became ill after being sent home and told to continue mixing SimplyThick with their milk.
Nobody knows what ingredient in SimplyThick is causing the problem. The FDA says an investigation is currently underway.
Parents are being advised not to give SimplyThick to their babies and to check with their doctor.
NEC signs and symptoms include bloody stools, greenish vomit and bloated stomach.
Side effects linked to SimplyThick intake can be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
According to Medilexicon's medical dictionary, Necrotizing Enterocolitis is:
"..extensive ulceration and necrosis of the ileum and colon in premature infants in the neonatal period; possibly due to perinatal intestinal ischemia and bacterial invasion."
Written by Christian Nordqvist