FDA Codeine Investigation Results in Fewer Prescriptions for Children
The FDA found that 1 in 20 children undergoing these surgeries were still prescribed codeine in December 2015.
HealthDay News — The US Food and Drug Administration (FDA) investigation into the safety of codeine use by children, which culminated in a black box warning in February 2013, led to substantially decreased codeine prescribing to children after tonsillectomy and/or adenoidectomy, according to a study published online in Pediatrics.
Kao-Ping Chua, MD, PhD, from the University of Chicago, and colleagues used the 2010-2015 Truven MarketScan Commercial Claims and Encounters database to identify 362,992 privately insured children who underwent tonsillectomy and/or adenoidectomy. They estimated changes in the proportion of children with at least 1 prescription fill for codeine and at least 1 fill for an alternative opioid within 7 days of surgery.
The researchers found that the FDA investigation was associated with a significant −13.3 percentage point level change in the proportion of children with at least 1 prescription fill for codeine after tonsillectomy and/or adenoidectomy. However, despite the decline, 5.1% of children had at least 1 prescription fill for codeine in December 2015. While the proportion of children receiving alternative opioids increased during the study period, the team said this was due to factors other than the FDA investigation.
"One in 20 children undergoing these surgeries were still prescribed codeine in December 2015 despite its well-documented safety and efficacy issues," conclude the authors.
One author disclosed ties to the General Electric Foundation.
Chua KP, Shrime MG, Conti RM. Effect of FDA investigation on opioid prescribing to children after tonsillectomy/adenoidectomy [published online November, 16, 2017]. Pediatrics. doi:10.1542/peds.2017-1765