Is Enfamil FDA Approved?

April 15, 2022
Is Enfamil FDA Approved?

Yes, the U.S Food and Drug Administration (FDA) has approved Enfamil baby formula. All baby formulas marketed in the U.S. must meet specific nutritional and other requirements set by the FDA.

Despite being approved by the FDA, Enfamil faces numerous lawsuits from parents seeking compensation for damages allegedly caused by baby formula products. These legal claims allege that Mead Johnson, the company behind Enfamil, failed to warn customers of the potential negative effects of feeding cow-milk-based formula to preterm infants.

How Can Enfamil Make Babies Sick?

Feeding premature infants cow-milk-based formula, including Enfamil, may put them at risk of developing necrotizing enterocolitis (NEC). 

NEC is a gastrointestinal disease that affects the intestinal tissues of preterm infants. It causes inflammation that can lead to tissue death and perforations in the intestines. Severe cases of NEC can lead to death.

Symptoms of Illness from Enfamil

Preterm babies' immune systems and digestive systems are fragile, and feeding them Enfamil may create significant harm. If you or a medical professional fed your baby Enfamil formula, watch for these potential symptoms of NEC:

  • Abdominal swelling
  • Diarrhea
  • Bloody stool
  • Green or yellow vomit
  • Extreme lethargy
  • Loss of appetite
  • Low blood pressure
  • Abnormal heart rate
  • Changes in breathing
  • Changes in body temperature

Per Cleveland Clinic, only about 80% of babies with NEC survive, so it is critical to get your child medical care as soon as possible after noticing any of these symptoms. 

How Is NEC Diagnosed?

After noticing the symptoms and taking your baby to their health provider, doctors may run the following diagnostic tests:

  • Blood Test.A blood test can check for any bacteria or viruses in the baby's blood or signs of infection.
  • Fecal Test.A fecal test checks for any blood in the baby's stool, even if it is not visible.
  • X-Ray.An abdominal x-ray can help detect air bubbles in and around the intestines, which could indicate NEC.

Potential Complications of NEC

NEC puts babies at risk of several complications, including: 

Short Bowel Syndrome

When NEC destroys an infant's intestines, they may develop short bowel or short gut syndrome. This condition hinders their body's ability to absorb fluids and nutrients. Children with this complication may need lifelong care to acquire the proper nutrients for growth, while some need a feeding tube.

Growth and Development Delays

NEC can cause long-term growth failure, neurodevelopment complications, and development delays. Infants with such complications require close monitoring for their growth.

Intestinal Stricture

NEC may cause the infant's intestines to narrow. A narrow intestine hinders food movement, and the baby may need surgery to take care of this problem.

Abdominal Infection

Due to NEC, an infant may develop a perforated hole in the intestinal wall, allowing bacteria to enter the abdominal cavity, resulting in an infection called peritonitis. This increases the child's risk of sepsis, a life-threatening blood infection.

Managing and Treating NEC

A baby with NEC may need treatments such as: 

  • Receiving fluids and nutrients via IV
  • Insertion of a nasogastric tube, which suctions gases and fluids from the stomach and out through the nose
  • Use of antibiotics to treat the bacterial infection
  • Insertion of an abdominal catheter
  • Surgery to repair holes in the intestines or remove dead tissue
  • Regular medical exams and checkups
  • Frequent blood tests

Types of Necrotizing Enterocolitis

Doctors classify NEC according to its cause, symptoms, and when it started. The different types of NEC include:

  • ClassicClassic NEC is most common and affects infants born prematurely, typically before 28 weeks of pregnancy. The baby is usually stable, but symptoms of NEC suddenly present 3-6 weeks after birth.
  • Transfusion-associated:A preterm baby may need a blood transfusion to treat anemia, and some develop NEC within three days of getting the transfusion.
  • Atypical:This type of NEC affects the infant within the first week of life or before their first feeding. This condition is rare.

How Can a Lawyer Help You If Your Baby Has NEC?

If your baby gets sick after drinking Enfamil formula, you may want to seek help from a lawyer. A lawyer can help you identify the liable party or parties for your infant's illness and help you seek compensation for medical bills, pain and suffering, and more. 

Our lawyers at Dolman Law Group will help you every step of the way as you file your lawsuit. We have experience in baby formula product liability cases, and we will help you seek the compensation you deserve.

Get Help from a Baby Formula Injury Lawyer

Our law firm offers a free consultation and evaluation of your personal injury case. We work on a contingency-fee basis, so you only have to pay legal fees after we settle or win the case.

Call us today to discuss your case's details and learn how to get started.