Codeine Use in Pediatric Patients

FDA Contraindications and Warnings

The FDA issued a boxed warning in 2013 regarding codeine use in pediatric patients, followed by a contraindication in April 2017 explicitly stating that "codeine should not be used to treat pain or cough in children younger than 12 years" 2
This contraindication applies to all codeine-containing products, including combination medications, regardless of what the product insert may suggest 2, 3
The FDA also recommends against codeine use in adolescents between 12-18 years who are obese or have conditions such as obstructive sleep apnea (OSA) 2, 4

Multiple codeine-related fatalities have been identified in the FDA's Adverse Event Reporting System database from 1969 to 2015, with 21 of 24 reported deaths occurring in children under 12 years old 2
The primary risk is respiratory depression due to genetic variations in metabolism - some children are "ultra-rapid metabolizers" who convert codeine to morphine more quickly, resulting in dangerously high morphine blood levels 2, 5

The American Academy of Otolaryngology-Head and Neck Surgery strongly recommends against codeine use in children under 12 years 1, 2
The American Academy of Pediatrics also recommends avoiding codeine in children 2
JAMA Surgery guidelines endorse FDA restrictions on codeine and tramadol for children younger than 18 years 4, 6

For pain management in children, safer alternatives include acetaminophen (paracetamol) 4, 7 and NSAIDs such as ibuprofen, which have not shown significant increase in bleeding risk compared to other analgesics 7

Even if a child has previously received codeine without apparent adverse effects, they should not continue to receive it due to unpredictable metabolism and the availability of safer alternatives 2