baby formula being poured into a bottle

Does Formula Cause Necrotizing Enterocolitis (NEC)?

Certain infant formulas have been linked to bacterial infections, including necrotizing enterocolitis (NEC). Although the exact cause of NEC is “not yet fully understood … Several studies have indicated that bovine milk–based infant formulas lead to a higher incidence of NEC in preterm infants than does human milk.”

In short, there is a potential link between cow milk-based formula and necrotizing enterocolitis, especially in premature babies.

What Is Necrotizing Enterocolitis?

Necrotizing enterocolitis or NEC is a serious gastrointestinal disease and the most common intestinal disease among premature babies. According to the National Institute of Child Health and Human Development:

In NEC, some of the tissue lining an infant’s intestine becomes diseased and can die.”

The intestines become injured and inflamed and can no longer hold waste. In severe cases, bacteria can pass into the bloodstream and cause a life-threatening infection, or waste can pass into the baby’s abdomen and make them extremely sick.

Sometimes, pieces of the intestine may need to be surgically removed.

NEC almost always occurs in premature or ill infants and usually develops in the 2nd or 3rd week of life. In addition to premature birth, risk factors include:

  • Underdeveloped intestines
  • Too little oxygen or blood flow at birth or later
  • Serious illness
  • Blood exchange transfusions
  • NEC outbreaks in infant nurseries or neo-natal units (NICUs)
  • Viral or bacterial infection of the intestines
  • Consuming formula rather than human milk

On average, treating NEC costs around $300,000 per infant, 20-40% of infants require surgery, and 25-50% of infants die from NEC.

What Are the Symptoms of NEC?

Symptoms of necrotizing enterocolitis may develop over a few days or appear suddenly. Common signs and symptoms of NEC include:

  • A swollen (distended), red, or tender belly
  • Trouble feeding
  • Inability to digest food
  • Constipation
  • Diarrhea
  • Dark or bloody stool/bowel movements
  • Vomiting green or yellow liquid (bile)
  • Decreased activity (lethargy)
  • A low or unstable body temperature
  • Weak pulse (bradycardia)
  • Pauses in breathing (apnea)
  • Low blood pressure (hypotension)

If your baby is exhibiting the signs and symptoms of NEC, contact your healthcare provider as soon as possible. Treatment can begin immediately after diagnosis and significantly reduce the risk of complications, as well as infant morbidity, and mortality.

What Baby Formula Is Linked to NEC?

Cow milk-based baby formula is linked to NEC. Brands mentioned in baby formula lawsuits include Similac® (manufactured by Abbott Laboratories) and Enfamil® (manufactured by Mead Johnson).

The lawsuits allege that Abbott and Mead Johnson failed to warn parents about the increased risk of NEC; failed to add proper instructions or guidelines for the use of bovine-based formulas (such as instructions to avoid feeding the formula to premature babies), and even neglected to list NEC as a possible side effect.

Allegedly, the companies marketed their products as safe for preterm infants, as well.

Recently, Abbot Laboratories recalled some Similac® products.

Does Similac® Cause NEC?

Similac® may increase the risk of necrotizing enterocolitis, but the cause of NEC is still unknown. Abbott recently recalled Similac® for cases of Cronobacter sakazakii infection, Salmonella, and deaths.

As a bacterial infection, Cronobacter sakazakii cannot only cause sepsis (blood infection), meningitis, and death but also increase the risk of NEC. Salmonella is another bacterial infection that can cause gastrointestinal illness, fever, and death – and increase the risk of NEC.

For more information on the Similac® recall, please consult the U.S. Food & Drug Administration (FDA).

Does Enfamil® Cause Necrotizing Enterocolitis?

As a cow milk-based formula, Enfamil® is associated with necrotizing enterocolitis, but other risk factors have not yet been ruled out, and scientists still don’t know what causes NEC.

Like Similac®, Enfamil® has faced issues with product tampering and contamination. In 2018, Mead Johnson pulled products from shelves nationwide and conducted an internal review when a Florida mother purchased an unopened package of Enfamil and found “what appeared to be all-purpose flour” inside.

Should I Feed My Child Formula?

Aside from recommending parents stop feeding their children recalled Similac® baby formula, the FDA has not spoken out against cow milk-based formulas, nor have manufacturers like Abbott or Mead Johnson warned parents about the risk of NEC.

Nevertheless, some researchers have found that human breast milk is better for babies and safer for preterm infants. Consult your doctor about what is best for your baby.

What If I Can’t – or Couldn’t – Breastfeed?

If you can’t breastfeed, discuss your options with your healthcare provider and consider getting human milk from a donor or using semi-elemental or elemental formulas to reduce the risk of NEC.

If you previously fed your baby Similac® or Enfamil® and your child became ill, it is not your fault. Abbott and Mead Johnson marketed their products as safe for all infants, including preterm babies.

What If My Baby Develops NEC?

If you fed your premature infant with Similac® or Enfamil®, and they have been diagnosed with necrotizing enterocolitis (NEC), you should consult an attorney about the potential to pursue a legal claim.

NEC is a medical emergency that at the least requires immediate treatment, causes severe emotional distress, and costs hundreds of thousands of dollars to treat.

At Brett H. Oppenheimer, PLLC, we know that you never would have fed your baby Similac® or Enfamil® if you knew about the risks, and you should not be responsible for the consequences of the formula manufacturer’s failure to warn.

Our firm can help you understand your legal options and, perhaps, fight for compensation and justice. We are deeply sorry for what you have gone through, and we want to help you and your family recover.

Brett Oppenheimer has been fighting for people like you since 1991, and he has recovered more than $100 million to help families move forward.

Tell us about your situation today – call us at (502) 242-8877 or contact us online for a free consultation with our award-winning attorney.

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