Yale Study Shows Link Between Hypophosphatemia and Neocate Baby Formula

In 2017, Yale researchers conducted a study to investigate unexplained hypophosphatemia in children. The results showed that children who were switched from Neocate to an alternative source of nutrition immediately saw improved levels of calcium and phosphate and eventual improvement in skeletal development.

The Method

This study was a retrospective chart review conducted in North America and Ireland between 2014 and 2016. Researchers collected data from children with unexplained hypophosphatemia who had been fed solely Neocate formula and developed many complex illnesses. The data was used to evaluate the potential for a relationship between the Neocate feeding and biochemical or clinical features.

Low P Levels

The Yale study reported in detail for a subset of the children studied. The ages of the children ranged from an 8-month-old girl to a 6.5-year-old boy. The reported serum P levels were all extremely low, indicating low phosphorus. According to Mayo Clinic, males and females 1-4 years old should have P levels between  4.3 and 5.4 mg/dL. These children reported P levels of 1.3 mg/dL, 1.7 mg/dL, 2.9 mg/dL, and 0.6 mg/dL. These P levels were well below the reference values, indicating severely diminished phosphorus levels. Phosphorus levels within the expected range are critically important in children, as they need phosphorus to help their bones develop properly.

The Results

Fifty-one children were identified in the Yale study, and their ages ranged from 0.2 to 15.5 years. The affected children had variable medical histories, but there was no single unifying explanation identified. The results of the study, however, were “remarkably consistent,” as almost all conditions improved when stopping the use of Neocate formula. In one of the cases, hypophosphatemia reoccurred when Neocate formula was re-introduced. This demonstrates the “peculiar association of the Neocate formula and hypophosphatemia.”

Contact GoldenbergLaw

If your child took Neocate and experienced hypophosphatemia, contact GoldenbergLaw. The manufacturer failed to do anything after knowing about this risk. We want to hold them accountable, and we want to fight for the justice you and your family deserve.


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Injuries Linked to Neocate Formula

Neocate, an amino-acid based baby formula, is linked to hypophosphatemia, or low levels of phosphates, and hypocalcemia, or low calcium levels. These conditions can cause severe injuries in children and babies, including:

  • Spontaneous or unexplained bone fractures
  • Bone pain
  • Broken bones
  • Stunted growth and development
  • Rickets (vitamin D deficiencies)

Many infants and children take Neocate due to the following conditions:

  • Cow milk allergy
  • Soy allergy
  • Multiple Food Allergies
  • Short bowel syndrome and malabsorption
  • Eosinophilic esophagitis (GERD or food allergies)

A 2017 study of children diagnosed with unexplained hypophosphatemia found that many of the participants relied on Neocate as their sole source of nutrition prior to or during the study. Many of the participants had suffered unexplained fractures and under-mineralization of the bone.  The study concluded that children who had switched to a different source of nutrition experienced improved levels of bone health. The authors recommended careful monitoring of bone health for children who rely on Neocate for their sole source of nutrition.

If your child is experiencing any of the symptoms of hypophosphatemia or hypocalcemia and has taken Neocate, it is important you contact your doctor right away. If Neocate is responsible for the injuries, call us at 612 – 436 – 5026 for a free consultation. Trust the experienced medical product attorneys at GoldenbergLaw. Contact us. You will sleep better.