引 致 更 改 给 病 人 的 产 品 资 讯 的 药 物 不 良 反 应 警 示
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| Australia: Check for pholcodine use before general anaesthesia (English only) |
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Therapeutic Goods Administration (TGA) announces that health professionals are reminded to check whether patients scheduled to undergo general anaesthesia with neuromuscular blocking agents (NMBAs) have used products containing pholcodine in the previous 12 months. This is due to a suspected link to an increased risk of potentially life-threatening anaphylactic reactions.
Pholcodine has been used in adults and children to treat non-productive cough and is most commonly used in non-prescription cough syrups and lozenge products. It has also been used in combination with other active substances in products that treat the symptoms of cold and flu.
TGA has recently made a decision to cancel the registration of pholcodine-containing medicines in Australia. All stock of pholcodine-containing products remaining on pharmacy shelves has also been recalled. The TGA decision followed a review by the European Medicines Agency recommending the withdrawal of marketing authorisations for these products in Europe. Health professionals are encouraged to discuss this safety issue with patients and to advise them to stop taking any pholcodine-containing medicines that they have. Recommend appropriate alternatives to treat cough and other cold and flu symptoms.
If a patient is scheduled to undergo general anaesthesia with NMBAs, check whether they have used pholcodine in the previous 12 months. Be aware of the risk of anaphylactic reactions in these patients. It is important to reassure patients this risk only applies to general anaesthesia containing NMBAs and not to local anaesthetics.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/check-pholcodine-use-general-anaesthesia
In Hong Kong, there are 28 registered pharmaceutical products containing pholcodine. All products are pharmacy only medicines. So far, the Department of Health (DH) has received one case of adverse drug reaction related to pholcodine, but this case was not related to anaphylaxis. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 19 Feb 2011, with the latest update posted on 15 Mar 2023. Letters to inform local healthcare professionals were issued by the DH on 1 Mar 2023. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Mar 17, 2023
Issued at HKT 14:30
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