Restrictions on use of codeine for pain relief in children

CMDh endorses PRAC recommendation

02-Jul-2013 - United Kingdom

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by consensus a series of risk minimisation measures to address safety concerns with codeine-containing medicines when used for the management of pain in children. codeine is an opioid that is authorised as a painkiller in adults and children. The effect of codeine on pain is due to its conversion into morphine in the patient’s body.

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 apnoea (frequent interruption of breathing during sleep).

Some of the children who had suffered severe side effects had evidence of being ‘ultra-rapid metabolisers’ 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.

The PRAC concluded that a number of risk minimisation measures are necessary to ensure that only children for whom the benefits are greater than the risks are given the medicine for pain relief. The CMDh agreed with the PRAC’s conclusions and endorsed the following recommendations:

Codeine-containing medicines should only be used to treat acute (short lived) moderate pain in children above 12 years of age, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen, because of the risk of respiratory depression associated with codeine use.
Codeine should not be used at all in children (aged below 18 years) who undergo surgery for the removal of the tonsils or adenoids to treat obstructive sleep apnoea, as these patients are more susceptible to respiratory problems.
The product information of these medicines should carry a warning that children with conditions associated with breathing problems should not use codeine.

The risk of side effects with codeine may also apply to adults. Codeine should therefore not be used in people of any age who are known to be ultra-rapid metabolisers nor in breastfeeding mothers (because codeine can pass to the baby through breast milk). The product information for codeine should also include general information for healthcare professionals, patients and carers on the risk of morphine side effects with codeine, and how to recognise their symptoms.

As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented directly by all Member States, according to an agreed timetable.

https://www.bionity.com/en/news/143809/restrictions-on-use-of-codeine-for-pain-relief-in-children.html