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Necrotizing enterocolitis (NEC) caused by infant formula

Necrotizing enterocolitis (NEC) is a serious gastrointestinal illness. Enterocolitis is an inflammation of the digestive tract, affecting the linings of the small intestine and the colon. When Intestinal tissue becomes inflamed, it hinders digestion. When intestinal tissue dies, (“necrosis” means the death of body tissue), it can perforate and allow bacteria to leak into the […]

Necrotizing enterocolitis (nec) caused by infant formula

Necrotizing enterocolitis

Necrotizing enterocolitis (NEC) is a serious gastrointestinal illness. Enterocolitis is an inflammation of the digestive tract, affecting the linings of the small intestine and the colon. When Intestinal tissue becomes inflamed, it hinders digestion. When intestinal tissue dies, (“necrosis” means the death of body tissue), it can perforate and allow bacteria to leak into the abdomen or bloodstream. In the bloodstream, that bacteria can cause systemic or bloodstream infection. In severe cases, this can be life-threatening.

Though NEC was first described in the 1800s, the cause of NEC remains unknown. It is believed that a decrease in blood flow to the bowel prevents the production of mucus that protects the gastrointestinal (GI) tract. The GI tract is the pathway for food from the mouth, through the esophagus, stomach, mall, and large intestine. Anything not absorbed by the GI tract is excreted as waste.

NEC occurs primarily in premature infants, who have a lower diversity of microbiota and a higher proportion of potentially harmful bacterial species. According to the National Institute of Child Health and Human Development, NEC impacts about 9,000 preterm infants born each year in the United States. NEC impacts 7% of very low birth weight infants and is the most common reason for a surgical emergency in newborn babies, leading to surgery in 20–40% of cases. Newborns weighing less than 4.5 pounds at birth make up about 80 percent of cases, but full-term babies have also been diagnosed.

Symptoms of NEC generally develop between 3 and 12 days after birth. They commonly include:

  • Abdominal bloating or swelling
  • Poor tolerance of feeding, with retention of feedings in the stomach
  • Stomach discoloration
  • Green fluid in the stomach, often vomited
  • Abdominal pain
  • Bloody bowel movements, often including diarrhea
  • Lethargy
  • Low heart rate or apnea
  • Drop in blood pressure, weakening of pulse

NEC can also cause short bowel syndrome (SBS) or short gut syndrome. If portions of the small intestine are damaged or must be removed, a child may lack adequate small intestine to absorb water and critical nutrients, including vitamins and minerals, protein, fat and adequate calories. Depending on how well the small intestine functions in a reduced state, treatment may require special diets and nutritional supplements, or parenteral nutrition (through a vein) to prevent malnutrition.

Standard diagnosis procedures for NEC include abdominal x-rays, which may reveal bubbles in the intestine or signs of air or gas in the liver’s large veins. A needle insertion into the abdominal cavity may find fluid, a sign of a hole in the intestine.

Multiple studies have found that babies who have had only breast milk (not formula) are less likely to develop NEC. Babies fed with cow milk-based formulas face a significant increase in the risk of NEC. The American Academy of Pediatrics has recommended breastfeeding and human milk, exclusively for six months, specifically referencing reduced occurrence of NEC.

Similac and Enfamil, two popular brands of infant formula given to newborns as a substitute for human breast milk, have drawn attention as possible causes of NEC. More than 30 lawsuits were filed against Mead Johnson and Abbot Laboratories, makers of the products, in Illinois state courts in 2021. Additional suits alleging the products caused NEC tripled the number over the first half of 2022, reaching 130 cases under the Multidistrict Litigation (MDL) in October.

Mead Johnson and Abbot Laboratories have also faced suit over alleged Cronobacter sakazakii bacterial contamination of their baby formula products. On February 28, 2022, Abbott Nutrition recalled a lot of Similac PM 60/40 powdered formula, manufactured in its Sturgis, Michigan plant, after the reported death of an infant. In August, Abbott announced the restart of production at the Sturgis facility.

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