Effect of FDA Investigation on Opioid Prescribing to Children After Tonsillectomy/Adenoidectomy

Pediatrics. 2017 Dec;140(6):e20171765. doi: 10.1542/peds.2017-1765. Epub 2017 Nov 16.


Background: In August 2012, the Food and Drug Administration investigated the safety of codeine use by children after tonsillectomy and/or adenoidectomy, culminating in a black box warning in February 2013. The objective of this study was to evaluate the association between the investigation and opioid prescribing to children undergoing these surgeries.

Methods: We identified 362 992 privately insured children in the 2010-2015 Truven MarketScan Commercial Claims and Encounters database who underwent tonsillectomy and/or adenoidectomy. Using an interrupted time series design, we estimated level and slope changes in the proportion of children with ≥1 prescription fills for codeine and ≥1 fills for an alternative opioid, such as hydrocodone, within 7 days of surgery.

Results: The investigation was associated with a significant -13.3 (95% confidence interval: -14.5 to -12.1) percentage point level change in the proportion of children with ≥1 prescription fills for codeine after tonsillectomy and/or adenoidectomy. Despite this drop, 5.1% of children had ≥1 prescription fills for codeine in December 2015. The investigation was not associated with significant level changes in alternative opioid prescribing, although the proportion of children receiving alternative opioids increased during the study period because of other factors.

Conclusions: The Food and Drug Administration investigation substantially decreased codeine prescribing to children after tonsillectomy and/or adenoidectomy. However, 1 in 20 children undergoing these surgeries were still prescribed codeine in December 2015 despite its well-documented safety and efficacy issues.

Publication types

  • Multicenter Study

MeSH terms

  • Adenoidectomy*
  • Adolescent
  • Analgesics, Opioid / therapeutic use*
  • Child
  • Child, Preschool
  • Drug Prescriptions / standards*
  • Female
  • Follow-Up Studies
  • Humans
  • Infant
  • Infant, Newborn
  • Interrupted Time Series Analysis
  • Male
  • Pain, Postoperative / drug therapy*
  • Postoperative Care / methods*
  • Retrospective Studies
  • Tonsillectomy*
  • United States
  • United States Food and Drug Administration*


  • Analgesics, Opioid