FDA Cautions Public About SimplyThick for Infants

FDA Cautions Public About SimplyThick for Infants

FDA Cautions Public About SimplyThick for Infants

On September 18, 2012, the Food and Drug Administration expanded its warning to parents, caregivers, and health care professionals about the thickening product called SimplyThick for infants. 

The FDA reports that 22 infants have developed necrotizing enterocolitis (NEC) after being fed the SimpyThick product since May of 2011.  NEC causes tissue within the intestines to inflame and die.  7 of the 22 infants died because of the NEC. 

The FDA admits that more studies are needed to find a link between NEC and SimplyThick.  In the meantime, the FDA has warned all parents and caregivers of the risks before using the product. 

The product is used by both consumers and medical centers to aid swallowing difficulties for infants.  The product is added to breast milk and formula to help premature infants swallow the milk and keep the milk down.  The product can also be used for children and adults who’ve suffered throat trauma. 

The MedWatch Safety Information and Adverse Event Reporting Program under the FDA first alerted Benson M. Silverman, M.D., of the negative side effects on May 13, 2011.  Silverman is the FDA’s director of Infant Formula and Medical Foods Staff. 

In the same month, the FDA recommended that infants born before 37 weeks should not eat the thickening agent.  Further warnings were issued.  The FDA proceeded to conduct a review of the product and the health concerns, and they found that a baby born at full term had also developed NEC after ingesting SimplyThick.  The other 21 infants were premature. 

The FDA reports that half of the infants were still in the hospital when developing NEC, and the other half developed the condition at home.  A total of 14 infants needed emergency surgery to fix the problem. 

The FDA advises parents to look for the following warning signs of NEC:

·  bloated stomach

·  greenish-tinged vomiting

·  blood in stool

If you believe your infant may have developed NEC, contact your local health care provider immediately. 

Source: Food and Drug Administration




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