A life-threatening bowel condition SimplyThick,® a thickener used to help infants with swallowing problems, is associated with a life-threatening bowel condition known as necrotizing enterocolitis (NEC). SimplyThick® is sold in 64-ounce bottles and individual packets; it is mixed with breast milk or infant formula to help babies ingest food without spitting it back up. The U.S. Food and Drug Administration (FDA) has warned that using SimplyThick® increases the risk of necrotizing enterocolitis in all babies that are exposed to it.
SimplyThick® linked to 22 cases of NEC, 7 Deaths
As of September 2012, the product has been linked to 22 cases of NEC, seven of which were fatal. According to a report in CNN, 21 of the infants who developed NEC after having SimplyThick® were born prematurely and one of them was born full-term. Half of the infants developed the condition in the hospital. Out of the 22 babies with NEC, 14 of them required surgery.
FDA Warns About Life-Threatening Bowel Condition
The FDA first warned about the link between SimplyThick® and necrotizing enterocolitis in May 2011. At the time, the agency said that the thickening agent should not be given to premature infants, specifically those born before 37 weeks of gestation. The warning came after the FDA became aware of two reports in the agency’s MedWatch Safety Information and Adverse Event Reporting Program. At the time, the FDA had received reports of 15 cases of NEC, including two deaths, following the use of SimplyThick®. In September 2012, the FDA updated its previous announcement to warn that the risk of NEC applied to infants of all ages who are exposed to SimplyThick®.
Necrotizing Enterocolitis (NEC) Signs and Symptoms
Necrotizing enterocolitis is when the lining of the intestines dies. The exact cause of this life-threatening condition is unknown, but it is known to mostly affect sick and premature babies. Infants who receive concentrated formulas and blood transfusions are also at a higher risk for NEC.
Signs of necrotizing enterocolitis include:
- Bloody stools
- Inability to feed
- Unstable body temperature
- Pain, swelling or tenderness in the abdomen (abdominal distention)
Approximately one-fourth of all NEC cases lead to death. Complications of NEC include intestinal perforation, sepsis, bowel obstruction, and peritonitis (inflammation of the abdominal lining).