Safety advice on particular drugs or classes of drugs
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| European Union: Start of review of codeine-containing medicines when used for cough and cold in children |
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The European Medicines Agency has started a review of codeine-containing medicines when used for cough and cold in children (aged below 18 years). This follows a previous review of these medicines when used for pain relief in children, which was triggered by concerns over the risk of morphine toxicity.
Following the previous review, several measures were introduced in order to minimise the risk of morphine toxicity when using codeine for pain relief. These included a recommendation that children with conditions associated with breathing problems should not use codeine. As the reasons for this recommendation may also apply to the use of codeine for cough and cold in children, the German medicines agency (BfArM) has now requested an EU-wide review of such use.
The European Medicines Agency will now evaluate the available evidence on the benefit-risk balance of codeine-containing medicines when these medicines are used for cough and cold in children.
While the review is ongoing, patients should speak to their doctor or pharmacist if they have any questions or concerns.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002072.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 354 registered pharmaceutical products containing codeine, which is an ingredient used to relieve pain and cough. Related news regarding the use of codeine have also been released by US FDA, EMA, MHRA and Health Canada and were posted on website of Drug Office. Letters to inform healthcare professionals on the issue were issued on 16 August 2012 and 7 June 2013. On 5 July 2013, the Registration Committee of the Pharmacy and Poisons Board (the Committee) decided that codeine is not recommended for use in children less than 12 years of age and the sales pack and/or package insert of pharmaceutical products containing codeine should be updated to include the appropriate safety information. The Department of Health will remain vigilant on any safety updates of the drug and actions taken by overseas regulatory authorities of any action deemed necessary.
Ends/ Saturday, April 12, 2014
Issued at HKT 12:00
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