Can SimplyThick Cause Necrotizing Enterocolitis (NEC) in a Premature Baby? The FDA Investigates

On May 20, 2011, the FDA released an immediate press announcement warning parents, neonatal intensive care physicians, pediatricians, caregivers and other healthcare providers not to use SimplyThick because it may be linked to causing necrotizing enterocolitis (NEC) or even death in premature infants. SimplyThick is thickening product that can be added to liquids to help gastroesophageal reflux disease (GERD), regurgitation, or spitting up of formula. As of May 13, 2011, the FDA was aware of 15 cases of NEC, including two deaths, of premature infants who were fed formula or breast milk fortified with the SimplyThick.

Necrotizing enterocolitis (NEC) is a life-threatening medical condition where portions of the bowel or intestines undergo necrosis or death. If not promptly diagnosed and treated, it can lead to death of the baby. Some of the symptoms of NEC are abdominal distention, bloating or a belly that is larger than normal, blood in the stool or bowel movements, feeding difficulties or feeding intolerance, diarrhea, lethargy or tiredness, trouble maintaining a normal body temperature and vomiting. If not diagnosed and treated, it can lead to an intestinal stricture or narrowing of the intestine, intestinal perforation or a hole in the intestine, infection in the abdomen or peritonitis, overwhelming infection or sepsis, and death.

NEC is usually seen in premature babies that are still in the hospital. However, what the FDA was finding out is that the NEC was occurring in premature babies that had already been discharged from the hospital. The FDA is continuing to investigate the possible link between SimplyThick and NEC and will provide more information as it becomes available. In the meantime, they are urging that SimplyThick not be used in feedings for premature infants that were born before 37 weeks gestation.

Here at the Beasley Philadelphia birth injury law firm we have specialized legal and medical teams that consist of doctors and nurses who have collectively worked over 60 years in neonatal intensive care units and newborn nurseries caring for premature infants and NEC (necrotizing enterocolitis). Our collective medical and legal knowledge assisted in obtaining two of the largest medical negligence verdicts in Pennsylvania history, $100 million and $55 million. In addition, we have evaluated thousands of product liability cases that have also injured many unsuspecting patients. To date, we have had billions awarded for our clients.

If your baby developed NEC while in the hospital or at home due to a defective or dangerous product that was used, please contact one of our experienced Philadelphia product liability attorneys at (215) 866-2424 for a risk free, no fee, and confidential consultation.


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