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SAHPRA issues withdrawal notice for pholcodine-containing products

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NMBAs are used as muscle relaxants during surgery. The risk of anaphylactic reactions to NMBAs is increased in patients who have used pholcodine-containing medicines up to 12 months prior to surgery. The available data provides strong evidence supporting the association between pholcodine use and the risk of developing anaphylactic reactions to NMBAs, particularly when used within 12 months before general anesthesia.

Effective measures to minimize the risk of anaphylactic reactions or to identify patients who may benefit from the use of pholcodine have not been identified. Since pholcodine is available without a prescription, it may not always be listed in patient records, and patients may not always remember if they have taken pholcodine-containing medicines in the past. In emergency surgery situations, patients may not be able to provide their medical history to healthcare professionals.

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Pholcodine is registered for the treatment of non-productive (dry) cough and is available in various non-prescription medicines, either as a single active ingredient or in combination with other medicines.

Considering the unpredictable and severe nature of the adverse reactions associated with pholcodine use, SAHPRA has concluded that the potential risks outweigh the benefits. As a precautionary measure, SAHPRA has made a regulatory decision to withdraw pholcodine-containing medicines from the South African market.

Alternative medicines for treating dry cough are available in South Africa, and consumers are advised to seek advice from their doctor or pharmacist. Patients should inform their healthcare professionals if they have used pholcodine-containing medicines, particularly within 12 months prior to surgery or general anesthesia.

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