其 他 安 全 警 示
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| European Union: European Medicines Agency confirms positive benefit-risk balance of pholcodine-containing cough medicines (English Only) |
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed that the benefits of pholcodine-containing cough medicines outweigh their risks and that these medicines should remain available for the treatment of non-productive (dry) cough in children and adults.
The review of pholcodine-containing medicines was initiated because of concerns that there could be cross-sensitisation between pholcodine and neuromuscular blocking agents (NMBAs) and a subsequent increased risk of anaphylactic reactions during surgery. These concerns were raised by a study that indicated that the reduction of pholcodine consumption following its withdrawal from the market in Sweden and Norway was associated with a decrease of reports of anaphylactic reactions to NMBAs in these two countries.
The Committee reviewed all available data on the safety and efficacy of pholcodine-containing cough medicines and found no firm evidence to substantiate the hypothesis of cross-sensitisation between pholcodine and NMBAs and a subsequent increased risk of anaphylactic reactions during surgery. The Committee also noted that pholcodine-containing medicines have been available for the treatment of non-productive cough in the EU for decades and existing data confirm a positive benefit-risk balance of these medicines. The Committee was therefore of the opinion that the marketing authorisations of pholcodine should be maintained in all EU Member States where it is currently authorised and that no further regulatory action is necessary.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/11/news_detail_001389.jsp&mid=WC0b01ac058004d5c1
Situation in Hong Kong: In Hong Kong, there are 38 registered products containing pholcodine. The related information was posted on the website of Drug Office in February 2011. Department of Health will keep vigilance against any safety updates from other regulatory authorities.
Ends/ Saturday, November 19, 2011
Issued at HKT 12:30
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