- The US Food and Drug Administration (FDA) is adding a new contraindication for all codeine- and tramadol-containing products, precluding their use in children aged <12 y.
Why this matters
- The action reflects a stronger stance than that of 2013, when boxed warning/contraindications were issued regarding codeine use after tonsillectomy and/or adenoidectomy.
- Codeine may not be used to treat pain/cough, and tramadol may not be used to treat pain in children aged <12 y.
- Tramadol may not be used to treat pain after tonsillectomy and/or adenoidectomy in children and teenagers aged <18 y.
- Both should be avoided in adolescents aged 12-18 y who are obese or have risk factors for breathing problems (eg, obstructive sleep apnea or severe lung disease).
- The FDA emphasizes that women taking codeine or tramadol should not breast-feed because of risk for excess infant sleepiness, difficulty breast-feeding, and potentially fatal breathing problems.
Why the changes?
- The FDA has received 64 reports of severe breathing problems (including 24 deaths) related to codeine use in children aged <18 y.
- 9 cases (including 3 deaths) were reported with use of tramadol in children aged <18 y.
- Most occurred in children aged <12 y, some after only a single dose.