FDA Warning issued on Simply Thick Formula Additive

On May 20th, 2011 the Food And Drug Administration issued a warning for consumers and health care professionals to discontinue using an infant formula thickening agent called SimplyThick.


What do you need to know about this FDA issued warning?

The FDA is advising parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants. The FDA is warning that this product may cause necrotizing enterocolitis (NEC), a life-threatening condition. The FDA first learned of adverse events possibly linked to the product on May 13, 2011. 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 product was mixed with mothers’ breast milk or infant formula products.

Illnesses have been reported from at least four different medical centers around the country and the illnesses of which FDA is aware, involve premature infants who became sick over the past six months. SimplyThick was added to the feeding regimen of those infants who later developed NEC to help with swallowing difficulties stemming from complications of premature birth

The current situation is unusual because NEC most often occurs in babies within the hospital early in their premature course. 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. NEC is a life-threatening condition characterized by inflammation and death of intestinal tissue. The condition is most often diagnosed in babies who are born prematurely. Signs and symptoms of NEC include appearance of a bloated abdominal area, appearance of illness, feeding intolerance, greenish-tinged (bile) vomiting and bloody stools. Premature infants currently receiving hospital care and premature infants discharged from the hospital within the past 30 days should not be fed SimplyThick.

What do you need to do if you still have some of this product or have been using this product?

Immediately discontinue use of this product and contact your health care provider for further information.

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. For more information about this warning you can read the FDA Press Release from May 20th, 2011. The FDA is actively investigating the link between SimplyThick and these illnesses and deaths and they will provide any updates as more information becomes available.