Tuesday, 28 May, 2024
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Sahpra probes cough medicines after global withdrawals

The SA Health Products Regulatory Authority (Sahpra) is investigating cough medicines containing the opioid pholcodine after authorities in Britain, the European Union and Australia pulled them from the market with safety concerns.

Pholcodine works by binding to opioid receptors in the brain and reducing nerve signals sent to muscles involved in coughing.

It has been used as a cough suppressant since the 1950s but recently sparked concern after being linked to triggering a rare, life-threatening allergic reaction, or anaphylaxis, in people who later undergo general anaesthetics.

This reaction can occur up to a year after they have taken medicine containing pholcodine, warned health experts.

The anaphylactic reaction is linked to the muscle relaxant drugs (neuromuscular blocking agents) used in about 50% of all general anaesthetics, reports The Independent.

Business Day reports that while pholcodine cough suppressants are not on the government’s essential medicines list or routinely provided in the state sector, they are easily available over the counter from pharmacies without prescription.

Investigations are in progress, according to Sahpra 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, and the patient had fully recovered, he added.

In December, the European Medicines Agency recommended revoking marketing authorisation for all pholcodine-containing medicines and withdrawing them after a review that followed a request from the French National Agency for the Safety of Medicines and Health Products in September. The French agency withdrew all pholcodine-containing medicines after preliminary results from a study raised red flags.

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, with retailers told to “quarantine” any remaining stock.

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 being marketed.


BusinessDay PressReader article – Regulator probes pholcodine safety (Open access)


The Independent article – Boots and Superdrug cough medicines withdrawn over safety fears (Open access)


See more from MedicalBrief archives:


Doctors more likely to recommend antihistamines than cough and cold medicine for kids


Parents too quick to medicate children’s fevers – US poll


Drug that eases symptoms of chronic cough may become first new therapy in 50 years





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