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Cow’s milk-based infant formula like Similac could raise a baby’s risk for serious illness
There are lots of reasons why a new parent might choose to formula-feed or breastfeed their baby. For several years, there’s been an aggressive push by health care professionals toward the “Breast is best” campaign, which suggests that breastfeeding is the healthier choice for moms and babies.
But not every parent can breastfeed. Sometimes there are medical reasons why it’s not ideal, the baby might not be able to latch, the baby could be cared for by someone other than the biological mother, or the mother might choose not to breastfeed—and the reasons are valid, no matter what they are. Some healthcare professionals (and others have been known to “formula shame” parents who choose not to breastfeed, but remember this... There’s more than one way to feed a baby.
The CDC reports that more than 83% of babies are fed some breastmilk shortly after birth, but the number of breastfed babies drops to nearly 79% by one month old. By six months of age, about 56% of babies consume some breastmilk, but fewer than 25% are consuming only breastmilk.
If a baby isn’t getting all of their nutrition from breastmilk, they need to be drinking formula. A baby under a year old needs formula because regular milk (cow, goat, etc.) does not have enough nutritional value to support a rapidly growing and developing body and mind.
Medical experts say that even if your baby is eating solid foods, the food is just a supplement and most of their nutrition still needs to come from breastmilk or formula until they’re a year old.
The FDA regulates baby formula and all formula legally sold in the United States. Every formula must follow FDA guidelines for safety and nutrition.
However, there have been side-effects caused by Similac formula consumption and if you’re feeding this product to your baby, it’s important to be aware of the signs and symptoms.
Common side-effects from Similac and other baby formula
Upset stomach, gas or diarrhea can be side-effects babies experience from formula. These are caused by a baby’s allergy to dairy or soy. Cow’s milk-based formula could increase a baby’s risk of necrotizing enterocolitis (NEC) in rare cases. NEC is a severe intestinal disease that primarily affects babies born prematurely.
Cow’s milk allergy from Similac formula
Similac milk-based formula contains nonfat milk and whey protein concentrate from cow’s milk. Cow’s milk is a common childhood allergen, and about 7% of babies under one year are allergic to cow’s milk protein.
For most babies with a cow’s milk allergy, symptoms would include skin rashes, stomach discomfort and nasal congestion. Babies with a severe allergic reaction could experience swelling or difficulty breathing.
Baby formula recalls
In February 2022, Abbott Laboratories recalled some Similac, EleCare and Alimentum formulas manufactured at its Surgis, Michigan factory. The recall was the result of an inspection that showed five strains of Cronobacter sakazakii within the factory, though the product samples did not appear to have the bacteria.
This voluntary recall by Abott was because babies were becoming sick from Cronobacter sakazakii; all of the infected babies were hospitalized and two died. This bacteria can cause sepsis, which is a life-threatening blood infection; and meningitis, which causes swelling in the membranes that surround the brain and spinal cord.
While there are pending Similac lawsuits, they are not related to Cronobacter recalls. Rather, the lawsuits claim that the manufacturer knew of the risk of NEC from cow’s milk-based formula and its potentially life-threatening effect on premature babies.
What are symptoms of NEC in infants?
A baby suffering from NEC might have these symptoms:
- Feeding difficulties
- Food remains in the stomach longer than normal
- Stomach is swollen, red or tender
- Vomit that contains bile (green)
- Lethargy, low activity
- Diarrhea or dark, bloody stool
- Low body temperature or temperature fluctuations
- Slowed heart rate
- Low blood pressure
- Apnea (breathing pauses)
Most babies who have NEC were born before 32 weeks’ gestation. There are some full-term babies who get NEC, and they usually have other health problems like heart defects.
The reason why formula-fed babies are more likely to develop NEC is that bacteria can invade the wall of the intestine, which can result in inflammation. However, it’s not exactly that the formula causes NEC—it’s suspected that the ingredients in infant formula, combined with its rate of delivery and the immaturity of the mucous membranes in the intestines can cause problems.
Some experts have suggested that you can reduce the risk of NEC in a premature baby by breastfeeding if possible, restricting the use of antibiotics, supplementing with probiotics and using standardized feeding protocols (SFPs).
Landmark study of Similac and NEC
In 1990, researchers from the UK studied 926 infants. 51 developed NEC. The researchers found that the babies who consumed cow’s milk-based formula were 6-10 times more likely to develop NEC than those who only drank breast milk. The babies who had both formula and breast milk were three times more likely to develop NEC than those who only had breast milk.
For babies who were more than 30 weeks’ gestation, NEC was 20 times more likely in the babies having only formula than those who had only breast milk.
The mortality rate for the premature babies who developed NEC in the study was 26%.
2016 study confirms earlier findings
Researchers from the Eunice Kennedy Shriver National Institute of Child Health and Human Development published a similar study in the Journal of Pediatrics in 2016.
They found that low-birth weight infants who consumed breast milk at least 98% of the time had a 1.3% occurrence rate of NEC. When low-birth weight infants had only formula, they had an 11.1% occurrence of NEC. Babies who had a combination of breast milk and formul had an 8.3% occurrence rate.
Therefore, this study confirmed the earlier findings from the UK that there is a link between formula and NEC in premature or low-birth weight babies.
Can I file a Similac lawsuit if my baby had NEC?
Similac makes high-calorie formulas that are intended for feeding premature babies. However, studies suggest that this product might result in a higher risk of NEC.
The lawsuits against Similar are not about whether or not the product causes NEC (there’s usually a combination of factors); it’s about the fact that Abbott Labs didn’t include a warning on the Similac label to inform parents of the risks.
Failure to warn
Failure to warn is one of three causes of action for a defective product lawsuit. Since studies have shown a link between Similac and NEC, it’s reasonable to expect that the manufacturer would provide a warning to parents and caregivers so they can decide whether to take the risk when feeding this formula to their infant.
The company should also provide this information to medical providers in order to allow them to wisely and correctly guide their patients.
If your baby suffered from NEC after consuming Similac and you weren’t warned of its risks, you might be eligible for a lawsuit. You can locate a personal injury lawyer who will work with you and your family to seek the compensation you need and deserve.
See our guide Choosing a personal injury attorney.