FDA to providers: Consider bone graft substitute alternatives
March 16, 2015
Silver Spring, Md.
— Health care providers should consider alternatives to using bone graft substitutes containing recombinant proteins or synthetic peptides with patients under 18 years old, U.S. Food and Drug Administration said in a safety notice published in January.
Reports of serious injuries, including excess bone growth, fluid accumulation, inhibited bone healing and swelling in young patients treated with bone graft substitutes containing recombinant proteins or synthetic peptides “have increased the FDA’s concern,” the group said in a statement.
Furthermore, the safety and effectiveness of these products for young people have not been reviewed or approved for use, according to the FDA. The administration recommends that providers carefully consider the benefits and risks before using these products in any patient and closely monitor patients under 18 for adverse effects.
Patients and health care professionals are encouraged to report adverse effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online at fda.gov
or by calling 1-800-FDA-0178 to request a form.