Necrotizing Enterocolitis (NEC) and Baby Formula Safety

Doug Mann

Few things are more important than keeping your baby safe and healthy. With premature infants, that often takes special care. Often, that care includes supplementing feeding with baby formula. Recently, it’s come to light that many common baby formulas–including some that are specially marketed for use with premature infants–actually increase babies’ risk of developing a serious medical condition called necrotizing enterocolitis (NEC). 

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Table of Contents
  1. Understanding NEC
  2. How Does Baby Formula Put Premature Infants at Risk? 
  3. Why are We Just Hearing about the Risks of Baby Formula? 
  4. Some Infants are at Greater Risk of NEC than Others
  5. What Baby Formula Contains Cow’s Milk? 
  6. What if My Baby Developed NEC after Consuming Cow’s Milk Formula? 

Understanding the signs and symptoms of NEC and how certain baby formulas put babies at risk is essential to protecting your premature infant.

Understanding NEC

Necrotizing enterocolitis is a gastrointestinal condition that can have serious consequences, and may even be fatal. Some of the signs that an infant may be suffering from NEC include: 

  • Abdominal inflammation
  • Stomach pain
  • Bloody diarrhea
  • Vomiting
  • Constipation
  • Refusing feedings
  • Lethargy
  • Unstable body temperature
  • Changes in heart rate and/or blood pressure

NEC triggers inflammation in the bowels that can result in tissue death and perforation of the bowel. Often, surgical intervention is required. 

When the bowel is perforated, contaminants may leak into the bloodstream. Bacteria in the bloodstream can trigger sepsis. Similarly, bacteria may leak into the abdominal cavity, leading to peritonitis. Both conditions can be fatal. 

How Does Baby Formula Put Premature Infants at Risk? 

Baby formula containing cow’s milk is believed to significantly increase the risk of necrotizing enterocolitis in premature infants. This presents a challenge for parents seeking safe baby formula for their pre-term babies because many formulas containing cow’s milk have been specifically marketed to parents of newborns. And, if you don’t know exactly what you’re looking for, labeling can be misleading. For example, a formula labeled as containing human milk proteins may also include cow’s milk derivatives. 

So, it’s important for families and pediatricians to know what to look for, and to know how significant the risks are based on characteristics of the child. 

Why are We Just Hearing about the Risks of Baby Formula? 

Many parents are asking this question, as studies have suggested a link between baby formulas containing cow’s milk and NEC for many years. In fact, one such study appeared in the prestigious medical journal Lancet more than 30 years ago. While that study focused on premature infants fed exclusively with cow’s milk formula versus the mixed diet that is more common today, the results were dramatic. Premature babies fed exclusively with cow’s milk were 6-20 times as likely to develop NEC as those who received at least some breast milk.

It took longer for studies comparing outcomes of infants receiving any cow’s milk with those whose diets were free of cow’s milk to be conducted and published. But, those studies began to appear several years ago. Still, many formula manufacturers continued to market formula containing cow’s milk specifically to the parents of premature infants as a tool for helping them put on weight. In fact, some companies are still manufacturing formula labeled for preemies with cow’s milk. 

Some Infants are at Greater Risk of NEC than Others

While any infant can develop necrotizing enterocolitis, the concerns about baby formula are based on increased risk to premature infants. And, some preterm babies are at greater risk than others. The risk of developing NEC is greatest among very small infants and those born earlier. But, the risk to larger, later-born preterm infants is also magnified by feeding with formula containing cow’s milk. 

Unfortunately, preemies are often the babies most likely to be provided with supplemental feeding, which has often involved the use of formula that contains cow’s milk derivatives. Many premature babies have even received formula containing cow’s milk as a supplement while in the hospital. 

What Baby Formula Contains Cow’s Milk? 

Most of the lawsuits filed in connection with formula-related necrotizing enterocolitis have been filed against two companies:

  • Abbott Laboratories (which manufactures Similac products)
  • Mead Johnson (which manufactures Enfamil products)

But, that’s largely because these are two very large companies manufacturing a significant percentage of baby formula sold in the United States. These two companies together produce more than 20 different baby formulas containing cow’s milk.

The problem is actually much more widespread. In fact, most baby formula contains cow’s milk–even formula that may be labeled as good for premature infants or tagged as containing human milk proteins.

An expert tip from Doug Mann

There is no comprehensive list of formulas that may present a danger to premature infants. The best way to protect your baby is to verify ingredients on any formula you are considering using, and to verify safety with your pediatrician. If your premature infant has to stay in the hospital, ask questions and ensure that the formula provided to your child in the NICU or neonatal ward is safe. 

What if My Baby Developed NEC after Consuming Cow’s Milk Formula? 

Parents whose babies suffered from NEC after being fed with cow’s milk formula are filing lawsuits in many states, including Ohio. These lawsuits are based in part on the claim that formula manufacturers knew or should have known that baby formula containing cow’s milk could be dangerous to premature infants, but failed to warn either parents or pediatricians of the risks. 

Under Ohio law, the statute of limitations for product liability claims is two years from the date the cause of action accrues. Usually, that means two years from the date the injury occurred, but there are exceptions. The best way to protect any claim you may have is to consult an Ohio attorney who handles product liability cases as soon as possible. 

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