Use of codeine in children restricted by EMA

Children should no longer be routinely prescribed codeine-containing medicines, the MHRA has confirmed, following a review prompted by safety concerns about an increased risk of respiratory depression.

The risk of respiratory depression outweighs the benefits of using codeine for moderate pain in children under 12 years as there are safer alternatives | SCIENCE PHOTO LIBRARY
The risk of respiratory depression outweighs the benefits of using codeine for moderate pain in children under 12 years as there are safer alternatives | SCIENCE PHOTO LIBRARY

The Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA has recommended that use of codeine-containing medicines in children be restricted to those aged over 12 years with acute moderate pain that cannot be relieved by other analgesics, for example, paracetamol or ibuprofen.

In addition, codeine should never be used for children under 18 years undergoing tonsillectomy or adenoidectomy to treat obstructive sleep apnoea. The prescribing information will also be updated to contraindicate codeine in conditions associated with impaired breathing.

The safety issue was raised in the MHRA's Drug Safety Update in December 2012, following post-surgical fatalities in ultra-rapid codeine metabolisers.

View codeine drug records

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