Safety of SimplyThick Additive, May Cause Life-Threatening Necrotizing Enterocolitis
(NEC) in Premature Infants
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
of NEC include:
- Bloated abdominal
- Appearance of
- Bloody stools