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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| Singapore: Withdrawal of Pholcodine-Containing Medicines in Singapore (English only) |
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The Health Sciences Authority (HSA) announces to inform the public that all pholcodine-containing medicines will be withdrawn in Singapore. The company marketing these products, iNova Pharmaceuticals (Singapore) Pte Ltd, is cancelling the registrations of these pholcodine-containing medicines and ceasing their supply in the local market. This is a precautionary measure due to overseas findings of a rare and very small risk of severe allergic reactions (i.e., anaphylaxis) to muscle relaxants (neuromuscular blocking agents or NMBAs) used during general anaesthesia in patients who have taken pholcodine, particularly in the preceding 12 months.
A safety study (ALPHO study) conducted in France found that there is a link between pholcodine and an increased risk of anaphylaxis with NMBAs used during general anaesthesia in surgeries. This safety risk is rare and assessed to be very low. To date, HSA has not received any local reports of NMBA-related anaphylactic reactions suspected to be associated with pholcodine.
HSA has conducted a review of the study and other available safety data and considered whether there are effective measures that can be taken to mitigate this safety risk. In consultation with medical experts from its Product Vigilance Advisory Committee, HSA has concluded that the potential risks outweigh the benefits of these products, and pholcodine-containing medicines should be withdrawn from the local market as a precautionary measure.
Patients are advised:
- If they are undergoing surgery involving the use of general anaesthesia and had taken any pholcodine-containing medicines, particularly in the past 12 months, they should inform the anaesthetist or doctor. The risk of anaphylaxis during surgeries is very rare. Anaesthetists are well trained to manage anaphylaxis and will take this into consideration during the surgery.
- To consult the doctor or pharmacist if they have any questions or concerns on the pholcodine-containing medicines or for advice on alternative treatments for dry cough.
In view of its regulatory decision, HSA has issued letters to healthcare professionals on the matters related to the withdrawal of pholcodine-containing products.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/news/withdrawal-pholcodine-containing-medicines
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 17 Mar 2023. Letters to inform local healthcare professionals were issued by the DH on 1 Mar 2023. The Registration Committee of the Pharmacy and Poisons Board is currently reviewing the safety of pholcodine-containing medicines and the issue will be further discussed in its upcoming meeting.
Ends/ Friday, June 23, 2023
Issued at HKT 16:00
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