FDA Alert: Do not feed the thickening product SimplyThick to infants because it has been found to cause necrotizing enterocolitis (NEC), a life-threatening condition. To date, at least 15 cases of NEC – including two infant deaths – have been linked to SimplyThick. The FDA is actively investigating the link between SimplyThick and these illnesses and deaths.
What’s the problem?
May 24, 2011 – This week, the U.S. Food & Drug Administration (FDA) issued a public alert warning parents and caregivers not to feed the thickening product SimplyThick to premature infants born before 37 weeks because it may cause a life-threatening condition known as necrotizing enterocolitis (NEC).
SimplyThick is a brand of thickening agent designed to help swallowing difficulties in premature babies. It is added to breast milk and formula to help keep food down without spitting up. SimplyThick may also be used in older children and adults with swallowing problems caused by throat trauma.
Incidents of negative side effects associated with SimplyThick first surfaced on May 13, 2011 with two reports to FDA’s MedWatch Adverse Event Reporting system. To date, the FDA is aware of at least 15 cases of NEC – including two infant deaths – involving premature babies who were fed SimplyThick. Nationwide, at least four different medical centers have reported the condition in infants over the past six months alone. The medical community is still unsure of what exactly in SimplyThick is making babies ill, but the FDA is currently investigating the situation.
Necrotizing Enterocolitis (NEC)
Necrotizing enterocolitis is a rare but extremely serious medical condition seen almost exclusively in premature infants that is characterized by necrosis (tissue death) in the bowels. The inner lining of the intestines contains millions of normally harmless bacteria called the ‘normal flora’ that are part of the digestive process. In NEC, however, the bacteria begin to attack the intestinal wall. Eventually, a hole can form through the bowel wall (a perforation), spilling its contents into the abdominal cavity. Bowel perforation is a medical emergency that requires immediate surgery and has a high mortality rate.
Although it affects only 1 in 2,000 to 4,000 births, or between 1% and 5% of neonatal intensive care unit (NICU) admissions, NEC is the most common and serious gastrointestinal disorder among hospitalized preterm infants. Signs and symptoms may progress rapidly and include:
- feeding intolerance
- increased gastric residuals
- abdominal distention
- bloody stools
- bloated stomach
- greenish-tinged vomiting
If your child is taking SimplyThick
If SimplyThick is currently part of your premature infant’s food regime, discontinue using it immediately and contact your healthcare professional if your baby is experiencing any of the side effects listed above. In the unfortunate event that your baby has contracted necrotizing enterocolitis or other serious side effect after consuming SimplyThick, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.