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  FDA Warns Not to Feed SimplyThick to Premature Infants
The FDA has warned that a thickening product called “SimplyThick” should not be fed to infants born before 37 weeks because it may cause a life-threatening condition. The FDA’s warning is based on reports of infants with necrotizing enterocolitis (NEC), in which tissue in the intestines becomes inflamed and dies. Parents should stop using the product even if their babies don’t appear sick.

SimplyThick is a thickening agent to help with swallowing difficulties. It is added to breast milk and infants’ formula to help premature babies swallow their food and keep it down, without spitting up.

So far, the FDA is aware of 15 cases of necrotizing enterocolitis (NEC), including two deaths. This is unusual because NEC most often occurs in babies while they are in the hospital early in their premature course. But some of the ill babies that FDA is aware of got sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.

For the complete FDA warning, click HERE.

If your baby has developed necrotizing enterocolitis (NEC) after being fed SimplyThick, please report it to the FDA, so the agency is aware of the full scope of the problem. You may make the report online HERE.

Categories: FDA, Drug Recalls

Posted By DeCarli Law on May 25, 2011 09:28 am | Permalink 

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Debra DeCarli and Bob DeCarli are licensed by the State Bar of Texas and the State Bar of California.

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