Codeine now contraindicated in under-12s with cough and cold

  • Date: 30 April 2015

THE use of codeine to treat cough and cold is now contraindicated in children below 12 years, according to new guidance from the European Medicines Agency.

Codeine should also not be administered to children and adolescents between 12 and 18 years who have breathing problems.

The new measures follow a review by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) which considered that the way codeine is converted into morphine in children below 12 years is more variable and unpredictable than in other age groups, making this population at special risk of side-effects. In addition, children who already have breathing problems may be more susceptible to respiratory problems due to codeine.

The PRAC also noted that cough and cold are generally self-limiting conditions and the evidence of clinical effectiveness in codeine use is limited.

The recommendations also state that codeine must not be used in patients of any age who are known to convert codeine into morphine at a faster rate than normal (‘ultra-rapid metabolisers’), nor in breastfeeding mothers.

For further details: Codeine-containing medicines

This page was correct at the time of publication. Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.

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