The popular amino acid-based baby formula Neocate is under review after two recent studies linked the product to infant birth injuries such as malnourishment, bone fractures and rickets.
Now, the manufacturer has revamped the formula to lower health risks and those families affected are being urged to learn about their legal options for compensation that could help with treatment for their babies.
What is Neocate Formula?
Neocate is a type of infant formula made for those children with food allergies or gastrointestinal issues due to intolerance to cow’s milk or soy-based formulas.
These can include:
Instead of cow’s milk or soy milk, Neocate is made from amino acids, which are elemental proteins that are usually easier to digest.
Neocate has been made since 1995 by Nutricia North America, a subsidiary of the European conglomerate Danone.
Neocate Linked to Infant Bone Problems
Last year, two studies out of the United Kingdom and United States raised questions about bone risks in infants fed exclusively with the amino acid formula Neocate.
First, researchers from a number of U.S. children’s hospitals including Boston Children’s Hospital, Yale and Columbia released findings in the April 2017 edition of The Bone Journal.
After noticing a trend of the low-blood-phosphate condition hypophosphatemia, which can lead to bone fractures, skeletal problems and rickets, they followed 51 children who were fed exclusively with amino acid-based elemental formulas.
They found that most of the bone problems were associated with those infants fed only Neocate, and that the problems improved by supplementing additional phosphate or changing formulas.
Next, researchers from children’s hospitals in the United Kingdom published a case study of several children with the bone disorder rickets in June 2017 at the International Conference on Children’s Bone Health.
They followed seven children between the ages of 5 months and 3 years who had received the infant formula Neocate exclusively and subsequently developed rickets, a disease resulting in soft or weakened bones.
They concluded that the problems were due to reduced intestinal absorption of phosphates, which improved after switching the children to a different protein-based formula.
In both studies, scientists identified poor absorption of phosphate as the cause for the children’s bone problems, which they attributed to the formula Neocate. They urged doctors to use caution when prescribing the product.
Neocate Bone Fracture Recall
According to Nutricia, the maker of Neocate, the bone disease problems identified in the two clinical studies only affect a small portion of children who use their product. And, they maintain, the formula is safe for most children.
However, company admitted that this April, they began rolling out a new version of their Neocate formula that has a more easily digestible phosphate.
This product change essentially amounts to a Neocate recall due to the phosphate absorption issues with the prior version.
Neocate Bone Disease Lawsuits
Based on the failure of Nutricia to properly warn doctors and consumers of the health risks of Neocate, lawyers believe those families affected are entitled to substantial compensation.
Anyone with an infant diagnosed with bone disease, bone fractures, rickets or phosphate deficiencies after using the formula Neocate should learn their legal options. It costs nothing to investigate your case or file a claim unless you receive an award. However, there is only a limited amount of time before your rights expire.
For more information on the health risks of Neocate, or to speak directly with a lawyer about your case at no cost, contact DrugNews today.
Sources:
Gonzalez, L. et al. Unexpected widespread hypophosphatemia and bone disease associated with elemental formula use in infants and children. Bone Journal (February 2017). Retrieved from www.thebonejournal.com
Sakka, S. et al. A rare cause of rickets. Bone Abstracts. (2017). Retrieved from www.bone-abstracts.org
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