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Post-Tonsillectomy Bleeding and Analgesic Use Before and After the FDA Boxed Warning Against Codeine

Chloe Cottone1, Arunima Vijay2, Anjalika Chalamgari2

  • 1Jacobs School of Medicine and Biomedical Sciences, The State University of New York at Buffalo, Buffalo, New York, U.S.A.

The Laryngoscope
|June 1, 2024
PubMed

Insights

Following the 2013 FDA warning, pediatric post-tonsillectomy analgesic use shifted away from codeine. This change correlated with a slight but significant increase in post-tonsillectomy bleeding incidents.

Area of Science:

  • Pediatric Otolaryngology
  • Pain Management
  • Pharmacovigilance

Background:

  • The 2013 FDA Boxed Warning advised against codeine use in pediatric tonsillectomy patients.
  • Understanding analgesic trends and hemorrhage incidence post-warning is crucial for patient safety.

Purpose of the Study:

  • To analyze changes in analgesic utilization after pediatric tonsillectomy.
  • To assess the incidence of post-tonsillectomy hemorrhage before and after the 2013 FDA warning.

Main Methods:

  • Retrospective study using the TriNetX US Collaborative Network (2008-2022).
  • Identified 15,648,542 patients up to 18 years old.
  • Analyzed analgesic use (codeine, ibuprofen, acetaminophen, oxycodone, ketorolac, hydrocodone) and hemorrhage rates.

Main Results:

  • Post-tonsillectomy bleeding incidence increased from 1.8% to 2.4% (p=0.029) after 2013.
  • Codeine use decreased significantly (10.4% to 0.5%), while ibuprofen, acetaminophen, ketorolac, and oxycodone use increased.
  • No change in hydrocodone use was observed.

Conclusions:

  • Pediatric post-tonsillectomy analgesic prescribing patterns have substantially changed since the 2013 FDA warning.
  • A statistically significant rise in post-tonsillectomy bleeding occurred concurrently with these analgesic shifts.
Abstract

Keywords:
FDA Boxed Warningcodeineibuprofenpost‐operative analgesicspost‐tonsillectomy bleedingpost‐tonsillectomy hemorrhagetonsillectomy

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