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

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

Chua KP1,2,3, Shrime MG4,5,6, Conti RM2,7.

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Section of Academic Pediatrics, Departments of Pediatrics,
Public Health Sciences and.
Department of Pediatrics and Communicable Diseases, Child Health Evaluation and Research Center, University of Michigan, Ann Arbor, Michigan.
Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.
Department of Otolaryngology, and.
Program in Global Surgery and Social Change, Harvard Medical School, Boston, Massachusetts.
Pediatric Hematology/Oncology, University of Chicago, Chicago, Illinois.



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.


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.


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.


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.

[Indexed for MEDLINE]
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