FDA Cautions about Use of SimplyThick for Infants

The U.S. Food and Drug Administration (FDA) first issued a warning in May 2011 that SimplyThick, a thickening agent, should not be fed to premature infants due to the possibility that it may cause necrolitzing enterocolitis (NEC), a life-threatening condition that damages the intestinal tissue.

At that time, the FDA was aware of 15 cases of NEC, including two deaths involving infants who were given SimplyThick. The FDA warned that, “parents, caregivers and health care providers not feed SimplyThick to infants born before 37 weeks gestation who are currently receiving hospital care or have been discharged from the hospital in the past 30 days.”

Illnesses were reported from at least four different medical centers around the country after SimplyThick had been added to the feeding regimen of premature infants. Some of these babies became sick over the following six months, after being discharged from the hospital, many that were being fed SimplyThick at home.

SimplyThick is a brand of thickening agent. It is sold in packages of individual servings and in 64-ounce dispenser bottles. It became popular due to its convenient, simple to mix with infant formula or breast milk, as well as maintaining its consistency, unlike rice cereal, previously used.

SimplyThick was promoted to health care professionals, parents and caregivers in order to thicken infant formula and breast milk for the purpose of assisting infants in swallowing and keeping their food down.

In June 2011, the FDA announced that SimplyThick was voluntarily recalling its SimplyThick gel manufactured at a food processing plant located in Stone Mountain, Georgia, due to concerns over contamination of the product.  When the product was returned to the market the following month, the FDA warned that SimplyThick was not to be fed to infants.

In September 2012, the FDA repeated it’s warning, but made one revision: The FDA said “infants of any age” might face an increased risk of developing NEC if fed SimplyThick.

Experts do not know how the product may be linked to the condition, but a number of babies have died after receiving SimplyThick. An FDA investigation of 84 cases, published in The Journal of Pediatrics in 2012, found a “distinct illness pattern” in 22 instances that suggested a “possible link” between SimplyThick and NEC. Seven deaths were reported and 14 infants required surgery.

NEC is the death of intestinal tissue that results in feeding intolerance, increased gastric residuals, abdominal distention and bloody stools. This disease can lead to intestinal perforation, requiring surgery and intensive medical support.

Symptoms of NEC include abdominal bloating or inflammation, appearance of illness, feeding intolerance, vomiting of bile (green in color), and blood in the stools. NEC can cause severe, permanent impairment or even death.

The fact that this product was used at all in the Neonatal intensive care units has resulted in several lawsuits.  Additionally, the question regarding regulatory oversight of food additives for infants has been raised.

The complaints further charge that the manufacturers of SimplyThick failed to adequately test, study and warn parents and the medical community of the risk to infants from being fed SimplyThick.  The SimplyThick lawsuit specifically allege that:

Defendants were or should have been in possession of evidence demonstrating that SimplyThick caused serious injuries in infants.   Still, Defendants continued to market SimplyThick by providing false and misleading information with regard to the safety and efficacy of SimplyThick, and failed to timely warn of the products’ risk when used in any infant.

SimplyThick is made from xanthan gum, which is a widely used food additive on the FDA’s list of substances “generally recognized as safe.” SimplyThick is classified as a food and the FDA did not assess it for safety.

SimplyThick lawsuits allege that in the intestine of infants, xanthan gum can trigger NEC, whether the baby is born premature or at full term.

SimplyThick has been widely used since 2001 by adults who have swallowing difficulties. A consistency similar to that of honey, allows the drinker more time to close his airway and prevent aspiration.

Doctors in Neonatal intensive care units routinely consult speech pathologists to determine whether an infant has a swallowing problem.  Speech specialists often recommend SimplyThick for use in infants with acid reflux (spitting up of food) or swallowing troubles.

It is still not known today how the thickener might have contributed to the infant’s deaths.  One possibility is that the infants’ digestive systems are just too fragile for xanthan gum.  Another possibility is that some batches of SimplyThick might have been contaminated with harmful bacteria.

In May 2011, the FDA inspected the plants of SimplyThick and found violations in the Stone Mountain plant, including a failure to “thermally process” the product to destroy bacteria of a “public health significance.”

The company, Thermo Pac, voluntarily withdrew some batches. Allegedly, some children may have ingested the potentially contaminated batches.

These tragic cases with SimplyThick do not only involve premature infants.  A full-term baby was given SimplyThick after a swallow test showed she had choking risks. The hospital speech pathologist recommended SimplyThick.  Less than one month later, the baby was dead with multiple holes found in her small intestine.

Until there is more data on xanthan gum use in premature infants or full-term infants, this product should not be used. As Dr. Yang, a neonatologist at Wake-Forest University, who co-authored a case series in the Journal of Perinatology, written about three premature babies who took SImplyThick and developed NEC, said, “The lesson I learned is not to be totally dependent on the speech pathologist.”  Basically, the infants are being prescribed this dangerous substance by a speech specialist, rather than by their pediatricians or neonatologist specialists.

Product recall is difficult because SimplyThick is a nationwide non-prescription product and is marketed as an aid for those who suffer swallowing disorders. Simply put, SimplyThick should never be given to children.

If you or a loved one developed adverse reactions from being given SimplyThick, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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