ResearchPublications

“On April 20, 2017, the Food and Drug Administration (FDA) issued a Drug Safety Communication (DSC) announcing a contraindication against codeine and tramadol use in children aged <12 years and against tramadol use in children aged <18 years after tonsillectomy and/or adenoidectomy. It also included a warning against codeine and tramadol use in adolescents with obesity or conditions that may increase the risk of respiratory depression. This DSC followed an FDA review identifying risks of respiratory depression and death associated with pediatric use of these medications and expanded upon the 2013 boxed warning against codeine use after tonsillectomy and/or adenoidectomy in children aged <18 years.

Codeine prescribing decreased after the 2013 boxed warning. The national impact of the 2017 DSC remains unknown. We examine the change in codeine and tramadol dispensing for treatment of pain to children aged <18 years after the 2017 FDA DSC.”