EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of codeine-containing medicines for cough and cold in children because of the risk of serious side effects with these medicines, including the risk of breathing problems.
The PRAC recommended specifically that:
- Codeine should be contraindicated in children below 12 years. This means it must not be used in this patient group.
- Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have problems with breathing.
- All liquid codeine medicines should be available in child-resistant containers to avoid accidental ingestion.
The effects of codeine are due to its conversion into morphine in the body. Some people convert codeine to morphine at a faster rate than normal, resulting in high levels of morphine in their blood. High levels of morphine can lead to serious effects, such as breathing difficulties.
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PRAC recommends restrictions on the use of codeine for cough and cold in children
