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EU Recommends Restriction on Codeine Use in Pain Relievers for Children

July 16, 2013

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended a series of measures to address safety concerns with codeine-containing medicines when used for the management of pain in children. This follows the PRAC's review of reports of children who developed serious adverse effects or died after taking codeine for pain relief. Most cases occurred after surgical removal of the tonsils or adenoids for obstructive sleep apnea.

The PRAC recommended the following risk-minimization measures to ensure that only children for whom benefits are greater than the risks are given the medicine for pain relief:

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 prescribing information should carry a warning that children with conditions associated with breathing problems should not use codeine.