Pholcodine cough medicines removed from Namibian shelves

The Namibia Medicines Regulatory Council (NMRC) has requested all healthcare professionals and importers to withdraw all pholcodine-containing products on Namibian shelves pending a council decision.

Pholcodine is an opioid medicine used to treat non-productive (dry) coughs.

This comes after preliminary findings from a study showed an increased risk of severe, life-threatening allergic reactions to neuromuscular blocking agents (NMBAs) – muscle relaxants used during anaesthesia – after the consumption of pholcodine.

The announcement was made by the registrar of medicines, Fransina Nambahu, in a media statement on Wednesday.

Nambahu said the European Pharmacovigilance Risk Assessment Committee evaluated all available data, which includes the final results of a study after marketing safety data and information submitted by third parties.

“The review showed that the use of pholcodine in the 12 months before general anaesthesia with neuromuscular blocking agents (NMBAs) is a risk factor for developing an anaphylactic reaction,” she said.

She said several regulatory authorities across the globe have taken actions, including the withdrawal and deregistration of pholcodine-containing products.

“As a precautionary measure, considering the seriousness of the safety risk as well as the lack of risk minimisation measures the council is requesting all marketing authorisation holders, importers and healthcare professionals to implement, withdraw and quarantine all pholcodine-containing products,” Nambahu said.

Other measures provided by the regulatory council include the suspension of prescribing, issuing or selling of pholcodine-containing products and considering alternative options to treat patients’ symptoms.

The council has also asked pharmacists to advise patients to stop taking pholcodine-containing products.

Nambahu yesterday said other cough medicines are available, adding that the withdrawal is only a precautionary measure pending the council’s decision on the products.

Following Alpho’s results, regulatory authorities have withdrawn prescription and over-the-counter preparations containing pholcodine from their markets.

This includes South Africa’s Health Products Regulatory Authority, the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, the Therapeutic Goods Administration of Australia and the National Pharmaceutical Regulatory Agency of Malaysia.

The executive director in the Ministry of Health and Social Services, Ben Nangombe, says the NMRC has to request a recall and the quarantining of these products as they pose a health risk to users.

“This is just to stop the suppliers and pharmacists from supplying and issuing these medicines to patients as there are health hazards associated with it,” he said.

The World Health Organisation (WHO) in March alerted health-care professionals and regulatory authorities of the risk of allergic reactions in people who have taken pholcodine-containing products at least 12 months prior to surgical procedures involving the administration of general anaesthesia with NMBAs.

According to the organisation’s website, available data showed that the use of pholcodine in the 12 months before general anaesthesia with NMBAs is a risk factor for developing a sudden, severe and life-threatening allergic reaction to NMBAs.

The organisation has advised healthcare professionals to advise their patients to stop taking pholcodine-containing medicines and consider appropriate alternatives to treat their symptoms.

They are also urged to 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.

Patients are urged to check if any of their over-the-counter cold and flu medicines contain pholcodine.

“Pholcodine is particularly used in cough lozenge (tablet) or syrup products, but can be found in other medicines. If they do, ask your doctor or pharmacist to suggest an alternative treatment,” the WHO said.

According to the European Medicine Agency, pholcodine depresses the cough reflex by reducing the nerve signals sent to the muscles involved in coughing.

Pholcodine has been used as a cough suppressant since the 1950s.