In 2013 the US FDA introduced restrictions on the use of codeine in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. The following are now being added:
• A contraindication to the drug labels of codeine and tramadol alerting that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.
• A contraindication to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.
• A warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 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.
• A strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
In the UK, codeine is contra-indicated in children younger than 12 years old, in breastfeeding mothers, and in patients of any age known to be CYP2D6 ultra-rapid metabolisers (see link below to related MHRA articles). Furthermore it is contraindicated in all children who undergo tonsillectomy or adenoidectomy (or both) for obstructive sleep apnoea, and it is not recommended for adolescents (12–18 years) who have problems with breathing.
In the UK, tramadol is not licensed for use in children aged below 12 years and the prescribing information (Zamadol® SPC) states that it should not be administered during breastfeeding. Although the SPC notes that respiratory depression has been reported infrequently and advises care when administering to patients with existing respiratory depression or to patients taking concomitant CNS depressant drugs, there is currently no specific warning or contraindication around use in children with conditions that may increase the risk of serious breathing problems.