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FDA: Do Not Feed SimplyThick to Premature Infants
Date:5/20/2011

tal 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.

What are the Symptoms of Illness/Injury?

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.

Who is at Risk?

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 Parents, Care Givers and Health care Providers Need To Do?  

Do not feed SimplyThick to premature infants.

Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider.

What Does the Product Look Like?

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 product label can be found here.

Where is it Distributed?

SimplyThick is distributed and can be purchased throughout the United States.

What is Being Done about the Problem?

FDA is actively investigating the link between SimplyThick and these illnesses and deaths. FDA will provide updates as information is made available.

Who Should be Contacted?

Parents and caregivers who ha
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SOURCE U.S. Food and Drug Administration
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