Authorities in New Zealand are seeking expert advice on the popular cough medication pholcodine after officials in Australia pulled all products containing the substance from sale.
The Australian Therapeutic Goods Administration (TGA) cancelled 55 products containing pholcodine from the Australian Register of Therapeutic goods , following a review by the European Medicines Agency (EMA).
The TGA said a safety investigation found an increased risk of anaphylactic reactions to certain medicines used as a muscle relaxant during general anaesthesia.
Pholcodine is used to treat dry cough and is a pharmacist-only medicine in New Zealand after it was reclassified in 2022.
An opioid drug that works directly in the brain, the medication suppresses the cough reflex by reducing nerve signals sent to the muscles involved in coughing.
In a press release issued earlier this week, the TGA said they had identified 50 Australian cases of suspected pholcodine-related anaphylactic reactions to the neuromuscular blockers used during general anaesthesia - including one fatality.
TGA Head Adjunct Professor John Skerrit urged Australians who had taken or suspect they have taken pholcodine medicines to speak to a doctor.
“If you will need general anaesthesia and have taken pholcodine in the past 12 months, I advise you to tell your health professional,” he said.
“Health professionals should also check whether patients scheduled to undergo general anaesthesia have used pholcodine in the previous 12 months.
The move was welcomed by Flinders University head of clinical epidemiology research Dr Ashley Hopkins.
“Pholcodine is a cough suppressant that has been associated with severe allergic reactions that can be life-threatening. These reactions can occur even in patients who have no history of allergy to any other medication,” she told news.com.au.
“In addition, there are several alternative medications available that can be used to treat coughs without the risk of anaphylaxis.”
Medsafe reacts
Medsafe told the Herald that it has received expert advice on this issue several times over recent years and this led to pholcodine being reclassified as restricted, pharmacist-only medicine.
They said one key purpose of the move was to ensure that the drug was taken after a consultation, noting that there was consumer demand for pholcodine products due to a dearth of other pharmaceutical alternatives for treating dry cough.
“Medsafe will be considering the decisions of the EMA and TGA including seeking further expert advice on the use of pholcodine in New Zealand,” they said in a statement.
“Consumers who have any questions should discuss the benefits and risks of pholcodine with their pharmacist.”
- additional reporting, news.com.au
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