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Press release: MHRA confirms codeine not to be used in children under 12 years old

Press release

Date: 28 June 2013
Time: 13:00
Subject: MHRA confirms codeine not to be used in children under 12 years old
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189

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, the MHRA confirmed today, following completion of a European review.

Where it 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.

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.

It has also been concluded that codeine should not be used at all 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.

Dr. Sarah Branch, Deputy Director of the MHRA’s Vigilance and Risk Management of Medicines Division said: “This is important new advice for the use of codeine for pain relief in children. Whilst codeine is not commonly used in children, the evidence is clear that there is risk of side effects in children, and other painkillers should be used whenever possible. People who have any questions should speak to their GP or pharmacist.”

Notes to Editor

  1. The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.
  2. Drug Safety Update: Volume 6, Issue 11 June 2013
  3. EMA press release (external link)
Page last modified: 28 June 2013