The CMDh has agreed by consensus new measures to minimize 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 in children below 12 years.
  • Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have breathing problems.

These measures will be directly implemented by the Member States where the medicines are authorized, according to an agreed timetable.

The review of codeine when used for cough and cold was initiated at the request of the German medicines agency under Article 31.

The PRAC has reviewed all available safety data and considered that children below 12 years are more likely to convert codeine into morphine in a more variable and unpredictable way than other age groups.  This leads to a special risk on having side effects due to codeine conversion, like respiratory problems. In addition, children already having breathing difficulties, may be more susceptible to these side effects.

As cough and cold are generally self-limiting conditions and the evidence that codeine is effective at treating cough in children is limited, the PRAC had made the above mentioned recommendations, which are now agreed on by the CMDh.

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