SA’s medicines regulator is investigating cough medicines containing pholcodine, after authorities in the EU, Australia and UK pulled them from the market over safety concerns.
Pholcodine is an opioid that has been used as a cough suppressant since the 1950s but has recently sparked concern because it may trigger sudden, life-threatening allergic reactions in people who later undergo general anaesthetic. This rare allergic reaction can occur up to a year later.
While pholcodine-containing cough suppressants are not on the government’s essential medicines list and therefore not routinely provided in the state sector, they are readily available in SA as they can be obtained at private sector pharmacies without a doctor’s prescription.
The SA Health Products Regulatory Authority (Sahpra) is aware of the safety concerns over pholcodine and investigations are in progress, said its spokesperson, Yuven Gounden. “A statement will be issued once a decision has been reached,” he said.
Only one case of an anaphylactic reaction linked to the use of pholcodine has been reported to Sahpra, and the patient has fully recovered, said Gounden.
An anaphylactic reaction is a sudden, life-threatening allergic reaction. These rare reactions in patients who have used pholcodine-containing cough suppressants have been linked to medicines used as muscle relaxants when patients undergo general anaesthesia.
The European Medicines Agency recommended in December that marketing authorisation for all pholcodine-containing medicines be revoked and that these products be withdrawn from the market, after a review triggered by a request from the French National Agency for the Safety of Medicines and Health Products in September. The French medicines agency withdrew all pholcodine-containing medicines after preliminary results from a study carried out in France raised safety concerns.
Earlier this month the Australian Therapeutic Goods Administration and the UK’s Medicines and Healthcare Products Regulatory Agency took similar steps and recalled cough suppressants containing pholcodine.
Gounden said seven cough medicines containing pholcodine are registered in SA. They are iNova pharmaceuticals’ Pholtex Forte, Pholtex Junior and Pholtex Plus; Aspen Pharmacare’s Procof; Ascendis Pharma’s Folcofen; Johnson & Johnson’s Sinutuss Linctus; and Innovata Pharmaceuticals’ Respinol Compound Linctus. While all medicines that are sold in SA must be registered with Sahpra, registration does not necessarily mean they are now marketed.
Pholcodine works by binding to opioid receptors in the brain and reduces the nerve signals that are sent to the muscles involved in coughing.
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