Other safety alerts
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| European Union: Review of pholcodine medicines started |
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The European Medicines Agency (EMA) has started a review of medicines that contain pholcodine following concerns that their use may put people at risk of developing anaphylactic reactions (a sudden, severe and life-threatening allergic reaction) to certain medicines called neuromuscular blocking agents (NMBA). Pholcodine is used to treat non-productive (dry) cough in adults and children and NMBAs are used in general anaesthesia to prevent spontaneous muscle movements to improve operating conditions.
The review was requested by the French medicines agency (ANSM) following preliminary results of a study (ALPHO) carried out in France. The results of the study suggested that taking pholcodine up to 12 months before general anaesthesia may increase the risk of having an NMBA-related anaphylactic reaction. Based on these results ANSM is considering, as a precautionary measure, to suspend the use of pholcodine-containing medicines in France.
The ALPHO study was carried out as a condition to the marketing authorisations of pholcodine-containing medicines following a previous safety review in 2011. At the time, the Agency's Committee for Medicinal Products for Human Use (CHMP) found no firm evidence that use of pholcodine may put people at risk of developing anaphylactic reactions to NMBAs and recommended that a new study (the ALPHO study) should be carried out to investigate this risk in people taking pholcodine.
While ALPHO study was ongoing, in 2021, a study in Australia linked pholcodine’s use to an increased risk of anaphylaxis to NMBA muscle relaxants. This led to a recommendation by PRAC to include relevant warnings in the product information of pholcodine-containing medicines.
The PRAC will now review the results of the ALPHO study together with all available data and assess their impact on the benefit-risk balance of pholcodine-containing medicines and issue a recommendation on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU. The Agency invites all stakeholders (e.g. healthcare professionals, patients’ organisations, the general public) to submit data relevant to this procedure.
Please refer to the following website in EMA for details:http://www.ema.europa.eu/en/news/review-pholcodine-medicines-started
Local Situation in Hong Kong: In Hong Kong, there are 28 registered pharmaceutical products containing pholcodine. So far, the Department of Health (DH) has received 1 cases 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 and 19 Nov 2011. The DH will remain vigilant on the conclusion of the review and any safety updates issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, Sep 3, 2022
Issued at HKT 12:00
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