The European Medicines Agency has started a review of codeine-containing medicines when used for cough and cold in children (aged below 18 years). This follows a previous review of these medicines when used for pain relief in children, which was triggered by concerns over the risk of morphine toxicity.
Codeine is converted into morphine in the body by an enzyme called CYP2D6. It is well-known that some patients who are ‘CYP2D6 ultra-rapid metabolisers’ convert codeine to morphine at a faster than normal rate, resulting in higher than normal levels of morphine in their blood. High levels of morphine can lead to toxic effects such as breathing difficulties.
Following the previous review, several measures were introduced in order to minimise the risk of morphine toxicity when using codeine for pain relief. These included a recommendation that children with conditions associated with breathing 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 (BfArM) has now requested an EU-wide review of such use.
The European Medicines Agency will now evaluate the 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.