May 24, 2011
FDA is alerting healthcare professionals and consumers about the dangers associated with SimplyThick® in premature infants. Use of SimplyThick® in infants born before 37 weeks gestation may cause necrotizing enterocolitis (NEC). Necrotizing enterocolitis is a life-threatening condition involving intestinal inflammation and tissue death. A total of 15 cases of NEC have been reported in premature infants fed SimplyThick®. Of these 15 cases, 2 deaths have been reported. Signs and symptoms of NEC include abdominal bloating, green-color vomiting, and bloody stools.
SimplyThick® is a thickening agent used in individuals with difficulties swallowing. SimplyThick® contains four major ingredients, including water, xanthan gum, citric acid, and potassium sorbate. In infants, it is added to formula or breast milk to help with swallowing and keeping food down.
Do not use SimplyThick® in any hospitalized premature infant or for a time period of 30 days after hospital discharge. FDA has not issued recommendations to discontinue use of SimplyThick® in other populations, including adults with dysphagia. No recall has been issued for this product. Report any adverse events related with SimplyThick® to the FDA MedWatch program.
Additional information can be found through the following links:
- MedWatch Alert:
- Press Release:
- Consumer Update:
- Product Photographs:
May 24, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.