Medicine recalls
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| The United Kingdom: Pholcodine-containing cough and cold medicines: withdrawal from UK market as a precautionary measure |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces advice for healthcare professionals regarding the withdrawal of pholcodine-containing medicines from the market.
Pholcodine is an opioid medicine approved in adults and children older than 6 years of age to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and influenza. Previous reviews have examined the link between prior use of pholcodine and an increased risk of anaphylaxis during general anaesthesia involving neuromuscular blocking agents (NMBAs). The potential for cross-reactivity between pholcodine and NMBAs was added to the product information for pholcodine-containing medicines in Jan 2022.
The MHRA review considered the cumulative safety information, including the results from the recently completed ALPHO study, which showed that use of pholcodine during the 12 months preceding anaesthesia was significantly associated with an increased risk of perianaesthetic anaphylaxis to NMBAs (adjusted odds ratio = 4.2; 95% CI 2.5 to 6.9). Data on the risk related to the use of pholcodine beyond the period of 12 months was not available from this study, although data from an earlier study in Norway suggest that the very small increased risk may persist for up to 3 years.
The Commission on Human Medicines (CHM) advised that there is sufficient overall evidence for an association with pholcodine, although the absolute risk of anaphylaxis remains very small in patients who have taken pholcodine. Anaphylaxis following use of NMBAs is roughly estimated as having an overall incidence of fewer than 1 case per 10,000 procedures. Given the advice of the CHM, and the lack of identifiable effective measures to minimise the increased risk of anaphylactic reactions to NMBAs, pholcodine-containing products are being withdrawn from the market as a precaution.
Pholcodine-containing products have only been available in the United Kingdom for purchase in a pharmacy. Pharmacists should provide advice to those who have any concerns about their medicine or would like to seek advice on alternative medicines or management of their symptoms.
The MHRA scientific review took place alongside a review conducted by the European Medicines Agency (EMA), which also concluded that the benefits did not outweigh the risks.
Advice for healthcare professionals:
- Pholcodine-containing cough and cold medicines are being withdrawn from the United Kingdom market as a precaution following a review which found that their benefits do not outweigh the increased risk of the very rare event of anaphylaxis to NMBAs used in general anaesthesia.
- Ask patients scheduled to undergo general anaesthesia involving NMBAs whether they have used pholcodine-containing medicines, particularly in the past 12 months, and maintain awareness about the potential for perianaesthetic anaphylaxis related to NMBAs.
- Do not dispense or sell pholcodine-containing medicines. Consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking pholcodine.
- Pharmacies should follow the MHRA Class 2 Medicines Recall Notice to quarantine stock of pholcodine-containing medicines and return it to the manufacturer.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/pholcodine-containing-cough-and-cold-medicines-withdrawal-from-uk-market-as-a-precautionary-measure
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 EMA and Australia Therapeutic Goods Administration, and was posted on the Drug Office website since 19 Feb 2011, with the latest update posted on 1 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/Wednesday, Mar 15, 2023
Issued at HKT 14:00
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