PRAC recommends restrictions on the use of codeine for cough and cold in children
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.
Further information is accessible under the link below.