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

WASHINGTON, May 20, 2011 /PRNewswire-USNewswire/ -- The following is being released by the U.S. Food and Drug Administration:

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Fast Facts

  • FDA is warning parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks.
  • The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.
  • Health care providers should stop administering the product 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 is the Problem?

The FDA is advising parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition.

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. 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 hospi
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SOURCE U.S. Food and Drug Administration
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