Nutricia Revamps Neocate Formula, Issues Updated Guidance Following Reports of Rickets, Unexplained Fractures, Other Bone Disorders

Published on April 30, 2018 by Sandy Liebhard

Nutricia has made some changes to  Neocate Formula, following reports linking the elemental formula products to hypophosphatemia (low phosphate levels), unexplained broke bones, rickets and other bone disorders.

According to the Clarion Ledger, the company recently began integrating a more highly-soluble phosphate into Neocate. A Nutricia spokesperson indicated that the revamped versions began rolling out earlier this month.

And while the company maintains that the reported bone problems have only affected a small segment of Neocate users with unique conditions, Nutricia has also assembled an expert panel and issued guidance to health care professionals regarding the appropriate monitoring of these patients.

What is Neocate Formula?

Elemental or amino acid formulas like Neocate are prescribed to infants and children who are unable to tolerate formula made from cow’s milk or soy due to:

• Cows’ milk allergy
• Soy allergy
• Multiple food protein intolerance (MFPI)
• GERD or Eosinophilic esophagitis or other Food-allergy-associated conditions.
• Short bowel syndrome
• Malabsorption
• Other GI disorders

Because Neocate is made from essential amino acids – protein in its simplest form – it is easier to digests than cows’ milk or soy formulas.

Neocate Bone Disorders

Nutricia’s decision to reformulate Neocate comes just a year after the medical journal Bone published a case study involving 51 infants and children who had been diagnosed with unexplained hypophosphatemia. The majority of subjects (94%) also suffered from unexplained bone fractures, undermineralization, or rickets.

All of the infants and children discussed in the paper had been on a diet consisting solely of Neocate Formula products for variable periods of time prior to their presentation. What’s more, all improved after they were prescribed supplemental phosphate or switched to a different formula.

“The widespread nature of the findings leads us to strongly recommend careful monitoring of mineral metabolism in children fed EF (elemental formula,” the study authors concluded.

Another paper published last year in Bone Abstracts highlighted seven cases in which infants fed only Neocate Formula developed hypophosphatemic rickets. Once again, the subjects improved after they were given supplemental phosphate or switched to a different formula.

“The fact that serum phosphate improved following weaning of Neocate supports its role in the causation of hypophosphatemia; poor intestinal absorption of phosphate is the assumed mechanism in infants exclusively fed with Neocate,” the authors concluded. “Clinicians should exercise caution in the use of EF in the absence of clear clinical indications. Infants who are being exclusively fed on Neocate should have close clinical and biochemical monitoring of bone profile, in accordance with existing guidance.”