Product Liability

FDA warns SimplyThick may cause deadly condition in preemies

The Food and Drug Administration (FDA) is warning parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to premature infants (born before 37 weeks gestation). The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.

The FDA first learned of serious problems possibly due to ingestion of 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 and fed to the infants.

Illnesses have been reported from at least four different medical centers around the country. In these cases, SimplyThick was added to the feeding regimen of premature infants to help with swallowing difficulties stemming from complications of premature birth. The babies later developed NEC.

This is unusual because NEC most often occurs in babies while they are still in the hospital. But in some of these cases, illnesses were reported in babies that had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.

NEC is a life-threatening condition characterized by inflammation and death of intestinal tissue. It is most often diagnosed in babies born prematurely. Symptoms of NEC include appearance of a bloated abdominal area, appearance of illness, feeding intolerance, greenish-tinged (bile) vomiting, and bloody stools.

Premature infants currently receiving hospital care and premature infants discharged from the hospital within the past 30 days should not be fed SimplyThick. Parents and caregivers with question should contact their doctors. Any serious side effects with this or any other medical product should be reported to the FDA MedWatch Adverse Event Reporting program at www.FDA.gov/Medwatch.