PRAC Reviewing Safety of Codeine for Cough/Colds in Kids

Megan Brooks


April 11, 2014

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety of codeine-containing medicines when used for cough and cold in children younger than 18 years, the agency announced today.

The review follows a previous PRAC review of these medicines when used for pain relief in children, which was triggered by concerns about the risk for morphine toxicity.

Codeine, a prodrug, is converted into morphine in the body by the CYP2D6 enzyme. It is well-known that some patients are CYP2D6 ultrarapid metabolizers and convert codeine to morphine at a faster-than-normal rate, resulting in higher-than-normal blood levels of morphine, which can be fatal.

There have been reports of children who died or developed life-threatening respiratory depression after taking standard age-appropriate doses of codeine for pain surgery.

After the previous review by PRAC, several measures were introduced to help minimize the risk for morphine toxicity when using codeine for pain relief.

These included a recommendation that children with conditions associated with respiratory problems should not use codeine.

"As the reasons for this recommendation may also apply to the use of codeine for cough and cold in children, the German medicines agency has now requested [a European Union]-wide review of such use," the EMA said.

The PRAC will review available evidence on the benefit–risk balance of codeine-containing medicines when these medicines are used for cough and cold in children. "While the review is ongoing patients or their carers should speak to their doctor or pharmacist if they have any questions or concerns," the EMA said.

When complete, the PRAC recommendation will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures–Human, which will adopt a final position.


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