Advice from FDA: FDA expands warning on SimplyThick


In November 2011, we wrote about a May 2011 US Food and Drug Administration (FDA) warning to not feed SimplyThick to infants who were born before 37 weeks of pregnancy.

SimplyThick is used to thicken liquids for adults or infants with swallowing problems. At that time, it was determined that this product may cause necrotizing enterocolitis (NEC) in very young, premature infants. NEC is a life-threatening condition that causes tissue in the intestines to become irritated and die. After issuing that warning, FDA conducted an extensive review of reports of health problems possibly tied to SimplyThick. Since May 2011, there have been 22 cases of infants who developed NEC. Seven of those infants died. Surprisingly, one infant was a full-term baby, not a pre-mature baby! In the latest warning, FDA wants parents, caregivers, and healthcare providers to be aware that infants of ANY age my face an increased risk of NEC if fed SimplyThick. Parents should contact their infant’s doctor before using SimplyThick.

You can find this article and more on FDA’s Consumer Health Information website at: This website features the latest updates on medicines and products regulated by the FDA. Sign up for a free email subscription here.

Created on December 7, 2012

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