The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has recommended that codeine-containing medicines should only be used in children over 12 years old to treat acute (short lived) moderate pain, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen. This is because some patients may be at an increased risk of rare but serious adverse reactions as a result of the way the body handles codeine and younger children may be particularly susceptible.
PRAC also recommends that it should not be used in any patient under 18 years old who undergoes the removal of tonsils or adenoids for the treatment of sleep apnoea. This is due to an increased risk of severe breathing difficulties. The committee has said that where codeine is used in children it should be used at the lowest effective dose and only for the shortest period of time recommended by the doctor.
Dr. Sarah Branch, Deputy Director of the MHRA’s Vigilance and Risk Management of Medicines Division said: “Whilst codeine is not particularly widely used for the treatment of pain relief in children this is important new advice. People who have any questions should speak to their GP or pharmacist.”
UK MHRA will be issuing detailed advice to healthcare professionals in due course.