The United States Food and Drug Administration (FDA) has been involved on-and-off recently in the examination of potential dangers caused by an infant’s use of SimplyThick including necrotizing enterocolitis (NEC). Back in 2011, the Food and Drug Administration (FDA) issued a warning that Simply Thick may be responsible for causing necrotizing enterocolitis (NEC) among infants born prematurely and recommended that premature infants not be fed SimplyThick.
Simply Thick is a popular thickening agent used for infants who have feeding difficulties to supplement breast milk or baby formula. In September of 2012, the Food and Drug Administration (FDA) made a small, yet profound revision to its earlier warning regarding Simply Thick and NEC. Instead of saying that only infants born prematurely were at risk of NEC when taking Simply Thick, the FDA now warns that infants, ‘of all ages’ may be at a higher risk of developing NEC if given SimplyThick.
The main active ingredient in SimplyThick is xanthan gum, which is how the product functions. Doctors believe that this gum may be responsible for causing NEC in infants. They believe that the infant’s young intestines are not adequately developed to handle the xanthan gum.
In the Food and Drug Administration’s latest update, they revealed that since May 2011, there have been several more cases of NEC and NEC formula deaths. Initially, in May of 2011, the FDA reported 15 cases of NEC and 2 NEC formula deaths. Since then, they have been notified of 22 more cases of NEC among infants who were fed SimplyThick, including 7 more NEC formula deaths.
Of those 22 reported cases the Food and Drug Administration (FDA) found that there was a ‘distinct illness pattern’ in which they could connect the NEC with SimplyThick. Of the 22 cases of NEC, 14 of which required surgery.
An infant born Feb 3, 2011 was noticed to have a slowed heart rate when he ate. Doctors figured that he was having trouble feeding, so they added a thickener to aid in the process. After he was discharged from the hospital, his parents were given Simply Thick to supplement his formula to help him eat. After only two weeks, he was back in the hospital due to a swollen belly and extreme pain. At that point, the majority of his small intestine had ceased to function and he died soon after, at only 66 days old.
If your child is currently suffering or has suffered from Necrotizing Enterocolitis (NEC), and they took a thickening agent like SimplyThick to supplement breast milk or formula, you may have a potential Simply Thick lawsuit against the makers of the thickening agent. Women across the nation are currently filing Simply Thick lawsuits on behalf of their infants suffering from this dangerous condition. Our Simply Thick Lawyers are currently standing by ready to offer a free consultation for your potential Simply Thick lawsuit.