FDA Links SimplyThick to Infant Deaths

Dangerous product lawyers at Pintas & Mullins Law Firm warn consumers about SimplyThick, a common beverage thickening agent that poses a danger to infants and small children. The FDA recently issued a warning highlighting this risk.

SimplyThick was designed for people, usually infants and older adults, who have trouble swallowing liquids on a regular basis. The FDA initially released a safety warning to parents advising them not to give this product to premature babies. Recently, the FDA extended this warning to apply to all infants.

The product raises the risk of developing a life-threatening condition called necrotizing enterocolitis (NEC). The condition damages the intestinal tissue, and may manifest through symptoms like a bloated stomach, greenish vomit, lethargy, and bloody stool. To date, the FDA has received reports of 22 infants who developed NEC after ingesting SimplyThick. Of these, 14 required surgery, and seven babies died.

Fortunately, the risk of NEC development is exclusive to SimplyThick products, and does not extend to other thickening agents. SimplyThick products were used, however, quite extensively in neonatal intensive care units throughout the country, which has resulted in a number of lawsuits.

In addition to these SimplyThick lawsuits, consumers are also raising concerns about the adequacy of regulatory oversight for infant food additives. The dangerous ingredient used in SimplyThick is xanthan gum, which is recognized by the FDA as a generally safe substance. Since SimplyThick is officially classified as a food product – instead of a dietary supplement, for example -the FDA did not assess it for safety before it was released onto the U.S. market.

Executives at SimplyThick marketed the product to speech language pathologists, knowing that they would in turn recommend the product for use in infants. Newborn intensive care unit doctors often ask speech pathologists to determine if an infant has any issues swallowing liquids. The President of SimplyThick acknowledged this point, stating that he felt there was not a need to test the product before release because the use and safety of beverage thickeners was already well established.

The product thickens beverages to about the consistency of honey, to allow the drinker additional time to close the airway and prevent aspiration. SimplyThick became popular because it was very easy to mix, could be combined with breast milk, and had a pleasing consistency. It became so popular that, at any given time, several babies in most nurseries throughout the U.S. would be on it.

The FDA first became aware of its problems in early 2011, and in May of that year, the agency issued its first safety alert. It highlighted that many infants developed NEC much later than normal, sometimes even a few days after they had returned home. This is especially dangerous because parents may not be immediately attuned to the signs and symptoms of NEC, which would lead to a delay in hospitalization and treatment.

Experts affirm that xanthan gum is not suitable for infant’s intestines, as their digestive systems are too fragile and much more susceptible to bacterial growth. It has not yet been ruled out that some lots of SimplyThick may have been contaminated with harmful bacteria, which could have led to the NEC fatalities. In 2011, the FDA inspected SimplyThick factories and found violations at one plant in Stone Mountain, Georgia. Among the violations included the failure to thermally process the product, which destroys bacteria.

Doctors recently published a study in the Journal of Perinatology, which examined three premature infants who developed NEC after taking SimplyThick. In the paper, doctors confirmed that the NEC was caused by stimulation of the immature gut by xanthan gum, and stated that there is a significant lack of data concerning the effects of xanthan gum in infants.

Product liability lawyers at Pintas & Mullins Law Firm highlight this story to warn parents about the dangerous risks of using SimplyThick in infants. Products of this type, which were released onto markets without safety testing, must be held responsible for endangering public health. If your child was given SimplyThick and developed NEC, you have important legal rights, and may be entitled to significant compensation for medical bills, pain and suffering, or wrongful death.