Codeine not to be used for coughs and colds in children under 12

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)1 agreed by consensus new measures to minimise the risk of serious side effects, including breathing problems, with codeine-containing medicines when used for cough and cold in children. As a result of these new measures:

  • Use of codeine for cough and cold is now contraindicated (must not be used) in children below 12 years.
  • Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years with breathing problems.

Codeine’s effects are due to its conversion in the body ie  Some people convert codeine to morphine at a faster rate than normal, giving high levelnto morphins of morphine in their blood. These morphine  high levels can lead to serious effects, such as breathing difficulties.

In addition to the new measures for children, codeine must also not be used in people of any age known to convert codeine into morphine at a faster rate than normal (‘ultra-rapid metabolisers’) nor in breastfeeding mothers, as codeine can harm the baby because it passes into breast milk.

This review comes after a previous review of codeine for pain relief in children, that resulted in several restrictions being introduced to ensure this medicine was used as safely as possible.

It was realised that similar considerations could apply to using codeine for coughs and cold in children, a second EU-wide review was started. The restrictions for codeine for cough and cold are largely in line with the previous recommendations for codeine when used for pain relief.

As the CMDh has now agreed the PRAC measures by consensus, the measures will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.

Information for patients

  • Following an EU-wide review of codeine when used for cough and cold, changes have been made to the way the medicine is used to ensure that the benefits continue to outweigh the risks in children and adolescents.
  • Medicines containing Codeine for coughs and colds must not be used in children under 12 due to risks from serious side effects, including breathing problems.
  • Children and adolescents between 12 and 18 years who have breathing problems, codeine is not recommended as they may be more susceptible to breathing problems due to codeine.
  • All patients known to be ‘ultra-rapid metabolisers’, i.e. can convert codeine into morphine very rapidly, must not use codeine for cough and cold as they can risk serious side effects with codeine.
  • Breastfeeding mothers must not take codeine as it can harm babies because it passes into breast milk.
  • Parents and caregivers who notice any symptoms in a patient given codeine should stop giving the medicine and seek medical attention immediately:

slow or shallow breathing,



small pupils,

feeling or being sick,

constipation and lack of appetite.

If you or your children are being treated with codeine and have questions or concerns about treatments, speak to your doctor or pharmacist immediately. …more

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