Regulator probes pholcodine safety

SA’s medicines regulator is investigating cough medicines containing pholcodine, after authorities in the EU, Australia and UK pulled them from the market on safety concern.

The opiod pholcodine has been used as a cough suppressant since the 1950s but recently sparked concern as 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 cough suppressants are not on the government’s essential medicines list and not routinely provided in the state sector, they are readily available in SA. They can be bought at pharmacies without a doctor’s prescription.

The SA Health Products Regulatory Authority (Sahpra) is aware of the safety concern 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 pholcodine use 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 cough suppressants have been linked to muscle relaxant medicines when patients undergo general anaesthesia.

In December, the European Medicines Agency recommended revoking marketing authorisation for all pholcodine-containing medicines and withdrawing these products 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 concern.

The Australian Therapeutic Goods Administration and the UK’s Medicines and Healthcare Products Regulatory Agency took similar steps this month 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. All medicines sold in SA must be registered with Sahpra, but registration does not necessarily mean they are now marketed. Pholcodine works by binding to opioid receptors in the brain and reduces nerve signals sent to muscles involved in coughing.