FDA Warns Against Bone Graft Substitute Use in Minors

The FDA has issued a safety alert recommending against the routine use of bone graft substitutes containing recombinant proteins or synthetic peptides among patients aged <18 years, emphasizing that the safety and effectiveness of these products have not been reviewed or approved for patients in this age group.

This warning was issued following reports of adverse events associated with the use of these kinds of bone graft substitutes among patients <18 years, such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling. While such side effects are comparable with those experienced by adult patients using these bone graft substitutes, the FDA considers these events to be more concerning in patients <18 years, given their generally smaller size and ongoing bone growth.

The FDA suggested that health care professionals treating patients <18 years consider the use of alternatives, such as autograft bone, allograft bone, and bone graft substitutes that do not contain recombinant proteins or synthetic peptides. The FDA said providers who deem a bone graft substitute containing recombinant proteins and synthetic peptides as the best or only treatment option should inform the underage patient and his or her parents or guardians about the risks associated with the product, as well as closely monitor the patient for adverse events.

Those who observe or suspect an adverse event associated with the use of these products should report the incident to FDA’s MedWatch Adverse Event Reporting program by submitting the form online at www.fda.gov/medwatch/report.htm, downloading it at www.fda.gov/MedWatch/getforms.htm, or calling 1-800-332-1088 to request it. Completed paper forms can be returned to the address on the pre-addressed form or faxed to 1-800-FDA-0178.