Effects of the FDA Codeine Safety Investigation on Racial and Geographic Disparities in Opioid Prescribing after Pediatric Tonsillectomy and/or Adenoidectomy.

Objective. Our objective was to examine the impact of the U.S. FDA's 2013 black box warning against codeine on codeine and other opioid prescription filling after pediatric tonsillectomy and/or adenoidectomy (T/A) overall and by child race and provider urbanity/rurality. Methods. Patients ≤ 18 who underwent T/A in 8/2011 to 8/2016 were identified in Ohio Medicaid claims. Interrupted time series analyses were used to evaluate the impact of the FDA warning on codeine or other opioid prescription filling post-T/A. Results. In August 2011, codeine prescription filling was lower among black than white children (P < .001) and among children treated at institutions in metropolitan counties than less populous counties (P < .001). The FDA warning was associated with a 24.0% drop in codeine prescription filling (P < .001) and 5.5% increase in alternative opioid prescription filling (P = .046). At conclusion, there remained geographic but no longer racial disparities in codeine prescribing. Conclusion. Codeine prescribing after pediatric T/A decreased after the FDA's black box warning. However, geographic disparities in codeine prescribing remain.