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 Goldenberg Lauricella
If your child took Neocate and experienced hypophosphatemia, contact Goldenberg Lauricella. 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.