Codeine restricted use in children

26th June 2013

The MHRA have restricted the use of codeine in children following the results of a European safety review (see our news item 16-10-2012). Codeine is now contraindicated in:

• all children age 0–18 years who undergo tonsillectomy or adenoidectomy (or both) for obstructive sleep apnoea
• all patients of any age known to be CYP2D6 ultra-rapid metabolisers.

In addition:

• codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone. The maximum daily dose should not exceed 240mg taken in divided doses up to four times a day at intervals of no less than 6 hours. It should be used at the lowest effective dose for the shortest period and for a maximum of 3 days
• codeine is not recommended for use in children whose breathing might be compromised, including those with: neuromuscular disorders; severe cardiac or respiratory conditions; upper respiratory or lung infections; multiple trauma; or extensive surgical procedures. Morphine toxicity may be increased in these settings
• codeine should not be used by breastfeeding mothers because of potential harm to the baby via the breast milk.

The regulatory authorities in the USA and Canada have issued similar restrictions and warnings.

MHRA advice

FDA advice

Health Canada advice