On April 20, the FDA required a contraindication be added to codeine and tramadol drug labels stating that the opioid medications should not be used to treat pain in children younger than 12 years. The agency is also requiring tramadol labels to warn against using the drug to treat pain after tonsil and/or adenoid surgery in children younger than 18 years. A similar contraindication, as well as a boxed warning, already exists for codeine.
In addition to the new contraindication requirements, the FDA is also adding two new warnings:
- A new warning recommending that codeine and tramadol not be used in 12- to 18-year-old adolescents who are obese or have obstructive sleep apnea or severe lung disease.
- A strengthened warning that breastfeeding mothers should not take codeine or tramadol because of the risk of serious adverse effects in infants
The new warnings and contraindications come after the FDA reviewed reports of severe adverse effects over several decades. The association noted that most cases of serious breathing problems occurred in children younger than 18 years, with the majority occurring in children younger than 12 years.
The FDA previously added boxed warnings for several immediate-release opioid pain medications in 2016. The association said it will continue to look at data and make additional changes if necessary.
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