FDA recommends against use of certain bone graft substitutes in under 18-year-olds
SILVER SPRING, Md., USA: On 21 January, the Food and Drug Administration updated its recommendations for the use of bone graft substitutes containing recombinant proteins or synthetic peptides in patients under the age of 18. Reports of serious injuries have raised the FDA’s concerns. It thus advises against routine use of such products in this population.
Certain recombinant proteins and synthetic peptides that promote new bone growth have been approved for orthopedic and dental use only in patients over the age of 18 who are skeletally mature. However, there is only limited evidence of their safety and effectiveness in patients under 18 who are still growing, the FDA stated.
The organization thus urged health care providers, such as dental and orthopedic surgeons, to consider other treatment options for younger patients with significant bone defects or rare bone disorders. These options include autograft bone, allograft bone, and FDA-cleared bone graft substitutes that do not contain recombinant proteins and synthetic peptides.
The FDA further highlighted that any product that affects bone growth could have the potential to negatively affect skeletal development by altering normal bone formation and growth. According to the FDA, excess bone growth, fluid accumulation, inhibited bone healing, and swelling were among the adverse effects reported.