其 他 安 全 警 示
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| European Union: EMA recommends withdrawal of pholcodine medicines from EU market (English only) |
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European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of medicines containing pholcodine, which are used in adults and children to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and flu, and has recommended the revocation of the EU marketing authorisations for these medicines.
During the review, the PRAC evaluated all available evidence including the final results of the ALPHO study, post-marketing safety data and information submitted by third parties such as healthcare professionals. The available data showed that use of pholcodine in the 12 months before general anaesthesia with neuromuscular blocking agents (NMBA) is a risk factor for developing an anaphylactic reaction (a sudden, severe and life-threatening allergic reaction) to NMBAs.
As it was not possible to identify effective measures to minimise this risk, nor to identify a patient population for whom the benefits of pholcodine outweigh its risks, pholcodine-containing medicines are being withdrawn from the EU market and will therefore no longer be available by prescription or over-the-counter.
Healthcare professionals should consider appropriate treatment alternatives and advise patients to stop taking pholcodine-containing medicines. Healthcare professionals should also check whether patients scheduled to undergo general anaesthesia with NMBAs have used pholcodine in the previous 12 months, and remain aware of the risk of anaphylactic reactions in these patients.
The PRAC recommendations will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for consideration at its next meeting in December 2022.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-recommends-withdrawal-pholcodine-medicines-eu-market
In Hong Kong, there are 28 registered pharmaceutical products containing pholcodine. So far, the Department of Health (DH) has received 1 case of adverse drug reaction related to pholcodine, but this case was not related to anaphylactic reaction. Related news was previously issued by EMA, and was posted on the Drug Office website on 19 Feb 2011, 19 Nov 2011 and 3 Sep 2022. As the above PRAC’s recommendations will now be sent to CMDh for consideration, the DH will remain vigilant on the development of the issue and safety update of the drug issued by EMA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Saturday, Dec 3, 2022
Issued at HKT 12:00
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