FDA: Providers should avoid using certain bone graft substitutes in children
The Food and Drug Administration today advised against routine use of bone graft substitutes containing recombinant proteins and synthetic peptides in patients under age 18, because their safety and effectiveness has not been reviewed or approved for use in this population. If these products are considered the best or only option after considering alternatives, health care providers should inform parents/guardians and patients about the risks and benefits of using the product when discussing surgical options, and report any associated adverse events to the FDA, the agency said.
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