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Parents, grandparents and other caregivers of infants who were born prematurely need to be aware that they should not feed the thickening product called SimplyThick to infants born before 37 weeks because it may cause a life-threatening intestinal condition.
On May 20, 2011, the Food and Drug Administration (FDA) issued a safety announcement to parents, caregivers and health care providers about infants who developed a serious intestinal disease called necrotizing enterocolitis (NEC) after...
Parents, grandparents and other caregivers of infants who were born prematurely need to be aware that they should not feed the thickening product called SimplyThick to infants born before 37 weeks because it may cause a life-threatening intestinal condition.
On May 20, 2011, the Food and Drug Administration (FDA) issued a safety announcement to parents, caregivers and health care providers about infants who developed a serious intestinal disease called necrotizing enterocolitis (NEC) after being fed previously pumped breast milk or infant formula thickened with SimplyThick.
In babies who have NEC, the inner lining of the intestines becomes inflamed and dies. NEC can lead to intestinal perforation (a hole develops in the intestine and intestinal contents spill into the abdominal cavity), peritonitis (diffuse inflammation and infection of the lining of the abdominal cavity), the need for abdominal surgery and death. Signs and symptoms of NEC include a bloated abdomen, appearance of illness, feeding intolerance, greenish-tinged (bile) vomiting, bloody stools and fever.
SimplyThick is a brand of thickening agent added to previously pumped breast milk and infant formula to help premature babies swallow their food and keep it down.
The FDA reported that it first learned of bad side effects possibly linked to SimplyThick on May 13, 2011. As of May 20, the agency was aware of 15 cases of NEC involving premature infants who were fed SimplyThick mixed with their mothers’ previously pumped breast milk or infant formula, including two deaths. The mixture was fed to infants for varying amounts of time.
This situation is unusual because NEC most often occurs in babies while they are in the hospital, early in their premature course. But some of the ill babies that the FDA is aware of became sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.
Read the full FDA safety announcement at www.fda.gov/ForConsumers/ConsumerUpdates/ucm256250.htm.
What You Should Do
If you are caring for an infant born before 37 weeks’ gestation, do not add SimplyThick to the infant’s previously pumped breast milk or infant formula.
If you have been feeding your premature infant SimplyThick, monitor the infant for any of the following symptoms: bloated stomach, greenish-tinged vomiting, bloody stools, feeding intolerance or fever. If your infant develops any of these symptoms, contact your infant’s health care provider immediately.
Report any adverse effects related to SimplyThick to the FDA MedWatch program.
- Online: www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
- Regular mail: Use postage-paid, pre-addressed FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: (800) FDA-0178
- Phone: (800) FDA-1088
