Recombinant bone morphogenetic protein in patients under 18 years of age

In January 2015, the US Food and Drug Administration (FDA) issued a drug safety communication warning related to the use of bone graft substitutes containing recombinant proteins or synthetic peptides in patients under 18 years of age. The safety communication cited reports of serious injuries such as excess bone growth, fluid accumulation, inhibited bone healing, swelling, and pressure on the adjacent vital organs following the use of bone graft substitutes containing proteins or synthetic peptides.

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