The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

The FDA has issued a warning to parents, caregivers, and health care providers not to feed SimplyThick to infants born before 37 weeks. SimplyThick is a popular thickening agent used for the management of swallowing disorders, but the FDA is now fearful that the product could cause a life-threatening bowel condition known as necrotizing enterocolitis or NEC. See the FDA press release here.

Necrotizing enterocolitis is a very serious condition characterized by severe inflammation and death of intestinal tissue and has a fatality rate approaching 25 percent. Signs and symptoms of NEC include appearance of a bloated abdominal area, appearance of illness, feeding intolerance, greenish-tinged (bile) vomiting and bloody stools. See the WebMD overview here.

The FDA first learned of a potential link between SimplyThick and NEC on May 13, 2011. The agency is currently aware of 15 cases of NEC, including two deaths, in premature infants that were fed SimplyThick for various periods of time.

SimplyThick is most commonly administered to premature babies while still under hospital care, some parents or care givers may be instructed to contue administering the product during the first 30 days following discharge. SimplyThick can be purchased at many local pharmacies throughout the nation.

The FDA is currently advising healthcare providers, care givers, and parents to immediately discontinue administering SimplyThick to premature infants. Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider.

The FDA is actively investigating the link between the use of SimplyThick and NEC and will provide updates as soon as they are available.

For more information please visit the FDA’s website here.

Comments are closed.

Of Interest