EMA issues new guidance on the use of codeine in children and diclofenac-containing medicines

The European Medicines Agency (EMA) has released new restrictions on use of codeine for pain relief in children. The Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) has a series of risk minimization measures to address safety concerns with codeine-containing medicines when used for the management of pain in children.

This follows a review of these medicines by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which investigated reports of serious and fatal respiratory depression in children after taking codeine for pain relief. Most of the cases occurred after surgical removal of the tonsils or adenoids for obstructive sleep apnea. Some of the children who had suffered severe side effects had evidence of being ‘ultra-rapid metabolizers’ of codeine. In these patients, codeine is converted into morphine in the body at a faster rate than normal, resulting in high levels of morphine in the blood that can cause toxic effects such as respiratory depression.

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