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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
Summary
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.
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