TGA recalls dozens of cough syrups, lozenges over potentially fatal link
Pholcodine is used in over-the-counter products including syrups and lozenges to treat dry cough. Photo: Getty
Dozens of common cough syrups and lozenges will be stripped from Australian shelves over an ingredient that could trigger a potentially fatal reaction.
The Therapeutic Goods Association (TGA) on Tuesday ordered a recall of 55 over-the-counter medicines used for colds and flus.
These included well-known brands such as Codral, Benadryl, Bisolvon Chemists’ Own, TerryWhite, Priceline, Difflam, Duro-Tuss and others.
The cough medicines contain the ingredient pholcodine which is the subject of the safety concerns.
Pholcodine is an opioid medicine used since the 1950s in products for treating dry cough and cold and flu symptoms.
It suppresses the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing.
When pholcodine is combined with medicines used during general anaesthesia there is an increased risk of an anaphylactic reaction, the TGA said.
A safety investigation found that people who took pholcodine in the 12 months before general anaesthesia were at risk of the allergic reaction.
“It is difficult to reliably predict who may be at risk of anaphylaxis during anaesthesia and some patients may not know if they have taken pholcodine medicines recently,” TGA head John Skerritt said in a statement.
“In addition, while surgical facilities may ask about which prescription medicines a patient is taking, they may not ask about over-the-counter products.”
Tweet from @TGAgovau
In a statement, the TGA said 55 products containing pholcodine were being cancelled from the Australian Register of Therapeutic Goods.
The products that were currently on pharmacy shelves were being recalled from pharmacies.
The TGA began investigating the medicines after the European Medicines Agency recommended withdrawing the products’ European marketing authorisations.
The TGA has so far received 50 reports of Australian cases of suspected pholcodine-related anaphylactic reactions, including one death.
What should consumers do?
The TGA said people should check if any of their over-the-counter cold and flu medicines contain pholcodine.
Pholcodine is particularly used in cough lozenge or syrup products, but can be found in other medicines.
“If you will need general anaesthesia and have taken pholcodine in the past 12 months, I advise you to tell your health professional,” said Professor Skerritt.
“Health professionals should also check whether patients scheduled to undergo general anaesthesia have used pholcodine in the previous 12 months.”
Professor Skerritt said patients should ask their doctor or pharmacist for advice on safer alternatives to treat a dry cough.
