FDA Issues Safety Alert for SimplyThick

The Food and Drug Administration (FDA) is warning consumers, physicians and other health care providers not to feed SimplyThick to infants born before 37 weeks. The infant formula is a thickening agent for management of swallowing disorders and may cause necrotizing entercolitis (NEC), a life-threatening condition characterized by inflation and death of intestinal tissue.

In a statement released May 20, 2011, the FDA says it first learned of adverse events linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula. The illnesses have been reported from four different medical centers around the country.

SimplyThick is sold in packets of individual servings and in 64-ounce dispenser bottles. It can be purchased from distributors and local pharmacies.

Learn more about this FDA Safety Alert at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm.

 
 

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