GPs must no longer prescribe codeine for coughs and colds to children under the age of 12 or breastfeeding mothers, the European drugs regulator has ruled.
The European Medicines Agency (EMA) announced the decision after a review of evidence confirmed that codeine is linked to serious side effects including breathing difficulties.
The regulator said use of codeine for cough and cold should also be avoided in children and adolescents aged between 12 and 18 years who have breathing problems.
The move comes after restrictions were already placed on use of codeine in children for pain relief – and means the drug should no longer be used at all in under-12s.
EMA advisors concluded that, because the way codeine is converted to morphine is highly variable in children under 12, the risk of morphine-induced side effects is too unpredictable in this age group to justify its use.
The drug should also be avoided in people of any age who are ‘ultra-rapid metabolisers’, who convert codeine into morphine at a faster rate than normal, and in breastfeeding mothers, as codeine passes into breast milk.
The UK medicines regulator, the Medicines and Healthcare Products Agency, immediately endorsed the new advice.
An MHRA spokesperson said: ‘Whilst codeine is not commonly used in children, the evidence is clear that there is a risk of side effects. If anyone has any questions, they should speak to their GP or pharmacist who can best advise on alternative treatments.’