FDA: codeine, tramadol contraindicated in kids
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- 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 e...18>12>