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Food and drug administration (FDA) restricts codeine and tramadol in children and adolescents
As part of an ongoing safety review, the FDA has further restricted the use of codeine and tramadol.
Codeine is contraindicated for the treatment of pain or cough in children <12 years.
Tramadol is contraindicated for the treatment of pain in children <12 years.
Codeine and tramadol are contraindicated in children <18 years to treat pain after surgery to remove the tonsils and/or adenoids.
It is recommended that codeine and tramadol are not used in adolescents 12−18 years who are obese or have conditions such as obstructive sleep apnoea or severe lung disease, which may increase the risk of serious breathing problems.
It is recommended that codeine and tramadol are not used by breastfeeding mothers.
Note: The restrictions for codeine reflect those issued in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2015 (for cough) and July …
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Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.