Questions Surround Safety of SimplyThick Additive, May Cause Life-Threatening Necrotizing Enterocolitis (NEC) in Premature Infants


Safety of SimplyThick Additive, May Cause Life-Threatening Necrotizing Enterocolitis

The Food and Drug Administration warning last year that SimplyThick, a food thickener additive, should be not fed to any infants likely came too late for many parents who blame the product for claiming the life of their newborn.

 

According to a New York Times report this week, some parents who lost an infant believe the company responsible for processing SimplyThick along with federal regulators are at least somewhat liable for the death of their baby.

 

SimplyThick became a trend in treating neonatal patients with swallowing problems. Based on the report, a physician would ask a speech pathologist to determine if a newborn baby or prematurely-born infant was suffering from a swallowing problem. If so, they’d recommend SimplyThick be added to breast milk or another formula to aid in swallowing. A drink with a thicker consistency allows the troubled swallower to avoid aspiration when the airway closed too quickly.

 

The problems exist because SimplyThick was never tested on infants for safety and some believe the company responsible for the product may not have properly processed it and several batches of it may have been contaminated when it reached the consumer level.

 

In the end, the FDA isn’t sure why infants are dying after they take SimplyThick with their regular feedings. Regulators are still searching for a link between the additive and cases of necrotizing enterocolitis (NEC), which has been determined to be the cause of death among infants who took SimplyThick.

 

Last year, the FDA published the results of an investigation in The Journal of Pediatrics where it found 84 cases of NEC among children who were given SimplyThick. Among them, 22 had a definite link between NEC and SimplyThick. Seven died and another 14 required emergency surgery to correct the condition.

 

Previously, the FDA issued a warning in 2011 that indicated that premature newborns should not be given SimplyThick. After the results of its investigation coupled with more adverse event reports among newborns who had been diagnosed with NEC, the agency updated its warning and stated that no newborn should be given SimplyThick.

 

SimplyThick is an additive made mostly of xanthan gum. While the FDA considers xanthan gum a safe food additive, the report indicates that the agency and the company manufacturing it have never tested its safety on infants. Experts interviewed by The Times believe that an infant’s fragile digestive system may not be ready for xanthan gum and that could be leading to bouts of NEC.

 

Further, one facility that manufactures SimplyThick in Georgia was cited last year because it had not properly processed the product and removed all potential contaminants, leading to speculation that infants who died may have ingested a contaminated batch of the additive.

 

Instead of testing it for safety on infants or premature newborns, SimplyThick was marketed to speech pathologists who then turned to neonatal doctors and began recommending it for helping newborns with swallowing problems. That practice turned into almost standard procedure at many hospitals and soon infants were being given SimplyThick without any tests showing that it was effective for newborns as it was for adults.

 

What is SimplyThick?


SimplyThick is a gel thickening agent that is used to help prevent choking. In 2001, adults who had difficulty swallowing began using the product. Through word of mouth, the product eventually became widely used in infants, even though it was never tested for safety. SimplyThick is made from xantham gum, a food-additive used in a number of products.

 

What is Necrotizing Enterocolitis (NEC)?


Necrotizing Enterocolitis, or NEC, is a serious and sometimes fatal bowel condition most commonly seen in premature infants. In patients with NEC, the lining of the small intestine becomes inflamed and dies. It tends to occur within the first two weeks of life, and affects 1 in 2,000 to 4,000 births, or between 1% and 5% of infants admitted to the neonatal intensive care unit (NICU). In some cases of NEC, holes develop in the intestine; when this occurs, bacteria can leak out into the abdomen and cause a potentially fatal infection known as peritonitis.

 

Signs of NEC include:

  • Bloated abdominal area
  • Appearance of illness
  • Feeding intolerance
  • Greenish-tinged (bile) vomiting
  • Bloody stools