No more codeine under 12 years old. The European Medicines Agency, with CMDh, has definitely contraindicated it because of its effects on the respiratory system.
Codeine for dry coughs or for the treatment of colds is prohibited for children under the age of twelve. After the Pharmacovigilance Risk Assessment Committee (PRAC), it is the CMDh (1) from the European Medicines Agency (EMA) which decided on April 25 by consensus to limit the use of this analgesic.
This body thus takes up the conclusions of the members of the PRAC by recommending a list of contraindications: in children under 12 years of age, during breastfeeding (the passage of codeine into breast milk represents a route of exposure breastfed children), in subjects known to be “ultra-rapid CYP2D6 metabolizers” (2), or in children and adolescents between 12 and 18 years of age with respiratory problems.
France already aligned with the European decision
For its part, France had not waited for this decision since the French National Medicines Safety Agency (ANSM) had recommended at the end of March “to take these new restrictions on use into account as of now”.
As a reminder, in France, codeine-based specialties are already contraindicated in the treatment of dry coughs in children under 30 months.
(1) Co-ordination Group for Mutual Recognition and Decentralised Procedure – Human
(2) In “CYP2D6 rapid metabolisers”, this transformation of codeine into morphine is faster. This results in higher morphine blood levels increasing the potential risk of toxicity and respiratory depression.
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