An investigation by the Food and Drug Administration is linking formula thickener SimplyThick to a life-threatening condition in newborns.
Although it is not known why, the thickener is causing necrotizing enterocolitis, a condition that damages intestinal tissue and can lead to death. The FDA looked into 84 cases and found 7 deaths linked to SimplyThick and 14 infants required surgery. Originally, the FDA warned against use by premature infants, but has since expanded that warning to all infants.
SimplyThick was used in neonatal centers across the country, and lawsuits have been filed since the report was released last September. The findings also revealed faults in the regulatory oversight of food additives for infants.
SimplyThick is made from xanthan gum, a food additive that is recognized as safe by the FDA. SimplyThick is also used by adults with swallowing difficulties. The thickener is often recommended to infants with swallowing problems or acid reflux. SimplyThick was a popular additive as it was easy to mix, could be used with breast milk and maintained its consistency.
A speech pathologist recommended that Julie Mueller feed her daughter SimplyThick after a test revealed she was at risk of choking. Less than a month later, her daughter was dead with multiple holes in her intestine.
Currently, it is not known how the thickener caused the deaths, but one possibility is the thickener is not suitable for the digestive system of newborns. Another possibility is that batches of the thickener may have been contaminated with bacteria.
The president of SimplyThick stated that there was no need to conduct studies as the use of thickeners and xanthan gum was already widely established.
For more information on product liability, please contact us.
Source: The New York Times, "Warning Too Late for Some Babies," Feb. 4, 2013.