SimplyThick, a beverage thickener for people who have trouble swallowing liquids, should not be mixed with breast milk or infant formula and given to babies, the FDA warns.

In babies, SimplyThick may raise the risk of a life-threatening condition marked by inflammation and death of intestinal tissue, the FDA warns.

The new warning extends a previous one stating that SimplyThick should not be given to premature infants born before 37 weeks due to risk of necrotizing enterocolitis (NEC).

To date, the FDA has identified 22 infants who developed NEC after being fed SimplyThick. All but one was born prematurely. Of these, seven died. Half of the babies developed NEC while they were in the hospital, and 14 needed surgery.  

NEC symptoms include:

• Bloated stomach
• Greenish vomit
• Bloody stools
• Diarrhea
• Lethargy

Specific to Single Product

This warning is specific to SimplyThick and does not include other thickening products, says FDA spokeswoman Tamara N. Ward. "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.”

SimplyThick and other thickeners are not meant for infants, period, says Jesse Reeves-Garcia, MD. He is the director of gastroenterology at Miami Children's Hospital. “Infants are not meant to be eating solid foods, so these products are not appropriate.”

Such products do have a role in older kids and adults with swallowing disorders. He also says he would not use these products to treat infant reflux.

SOURCES:Tamara N. Ward, FDA spokesperson.Jesse Reeves-Garcia,MD, director of gastroenterology, Miami Children's Hospital.News release, FDA.

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