Safety advice on particular drugs or classes of drugs
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| European Union: Codeine not to be used in children below 12 years for cough and cold |
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The CMDh has agreed by consensus new measures to minimise the risk of serious side effects, including breathing problems, with codeine-containing medicines when used for cough and cold in children. As a result of these new measures:
Use of codeine for cough and cold is now contraindicated in children below 12 years. This means it must not be used in this patient group.
Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have breathing problems.
The new measures follow a review by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). As the CMDh has now agreed the PRAC measures by consensus, the measures will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
http://www.ema.europa.eu/../news_detail_002316.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 348 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, Health Canada and HSA 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 keep vigilant on the safety updates of the drug.
Ends/ Saturday, April 25, 2015
Issued at HKT 13:30
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