Abstract

This cross-sectional study uses national prescription data to assess whether safety communications from the US Food and Drug Administration (FDA) issued in 2017 and 2018 were associated with changes in prescriptions for codeine and hydrocodone cough and cold medications to children and adolescents.

Highlights

  • Cough and cold medications containing codeine or hydrocodone are associated with misuse and addiction in adolescents and with potentially fatal respiratory depression in young children.[1,2,3,4] On April 20, 2017, the US Food and Drug Administration (FDA) issued a safety communication announcing a contraindication against all codeine use in children aged 0 to 11 years.[1]

  • We conducted a cross-sectional analysis of 2014-2019 IQVIA Longitudinal Prescription Data, which includes all prescriptions dispensed from 92% of US retail pharmacies

  • Using an interrupted time series design, we evaluated the association between the 2 FDA safety communications and monthly prescriptions for codeine cough and cold medications to children and adolescents aged 0 to 17 years

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Summary

Introduction

Cough and cold medications containing codeine or hydrocodone are associated with misuse and addiction in adolescents and with potentially fatal respiratory depression in young children.[1,2,3,4] On April 20, 2017, the US Food and Drug Administration (FDA) issued a safety communication announcing a contraindication against all codeine use in children aged 0 to 11 years.[1]. We assessed whether these communications were associated with changes in prescriptions for codeine and hydrocodone cough and cold medications to children and adolescents.

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