Safety advice on particular drugs or classes of drugs
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| Updates on the use of codeine |
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1. The United Kingdom: MHRA confirms codeine not to be used in children under 12 years old
The MHRA confirmed 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, 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."
Please refer to the following website in MHRA for details:http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON287048
2. European Union: Restrictions on use of codeine for pain relief in children -Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) endorses Pharmacovigilance Risk Assessment Committee (PRAC) recommendation
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(European Medicines Agency)'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).
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 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.
The PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented directly by all EMA Member States, according to an agreed timetable.
Detailed risk minimisation measures and recommendations for patients / healthcare professional are available at the link below.http://www.ema.europa.eu/../news_detail_001829.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 369 registered pharmaceutical products containing codeine, which is an ingredient used to relieve pain and cough. Related news has also been released by US-FDA, EMA, MHRA and Health Canada posted on website of Drug Office on 16 August 2012, 21 February 2013, 7 June 2013, 15 June 2013 and 29 June 2013 respectively. Letter to inform healthcare professionals on the issue was issued on 16 August 2012 and 7 June 2013. In April 2009, the Registration Committee of the Pharmacy and Poisons Board (the Committee) had decided that pharmaceutical products for the treatment of cough and cold should not be used for children under 6 years of age, and the label of cough and cold products should be revised accordingly. The new recommendations by EMA will be discussed in the meeting of the Committee and the Drug Office of Department of Health will remain vigilant on new safety information related to codeine by other regulatory authorities.
Ends/ Saturday, June 29, 2013
Issued at HKT 17:00
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