SAHPRA withdraws non-prescription cough medicines containing pholcodine from market due to risk of life-threatening allergic reactions during surgery

In recent news, South African pharmacies have withdrawn certain cough medicines from their shelves due to concerns over the misuse and abuse of these products. This action has sparked a debate regarding the regulation of cough medicines and the role they play in public health. In this article, we will explore the reasons behind the withdrawal of these medicines and the potential consequences for those who rely on them for relief from coughs and colds.


South Africa’s Health Products Regulatory Authority (SAHPRA) has ordered the withdrawal of all pholcodine-containing medicines from the market due to a heightened risk of severe and life-threatening allergic reactions during surgery. Sahpra advised users of these non-prescription cough medicines to stop using them. NMBAs (neuromuscular blocking agents) are used as muscle relaxants during surgery. The use of pholcodine-containing medicines, up to 12 months prior to surgery, increases the risk of a sudden, severe and life-threatening allergic reaction in patients receiving NMBAs. Sahpra suggests that pholcodine use is associated with the risk of developing such a reaction to NMBAs, particularly for those who have used it within the year prior to general anaesthesia. As pholcodine is a non-prescription medicine, some available patient records may not list its use, and patients may not always recall whether they have taken pholcodine-containing medicines in the past. 
SAHPRA has not identified effective measures to minimise the risk of anaphylactic reactions to NMBAs, or identify a patient population for whom the benefits of pholcodine outweigh the risks. As a precautionary measure, in light of the severity and unpredictability of the reaction, Sahpra has decided to withdraw pholcodine-containing medicines from the South African market. The authority is working with manufacturers to ensure that all pholcodine-containing medicines are removed from distribution facilities, including pharmacies, distributors, and other authorised health facilities. 
Pholcodine is available in several non-prescription medicines, either as a single active ingredient or in combination with other medicines, to relieve patients of a dry cough. Patients are urged to return these medicines to the pharmacies. Doctors are warning the public to seek medical attention immediately should they display any symptoms of an allergic reaction, such as cardiac arrest, difficulty breathing, and skin rash. 
In conclusion, the decision to withdraw pholcodine-containing cough medicines was made by SAHPRA to protect the public from the risk of sudden, severe, and life-threatening allergic reactions during surgery. SAHPRA found that the available data provide sufficient proof to support the association of pholcodine use with the risk of developing an anaphylactic reaction to NMBAs in some patients. As such, Sahpra has not yet identified any alternative solutions to manage this risk, and its precautionary measure ensures public health and safety.