The Therapeutic Goods Administration (TGA) has recalled 44 products containing the cough suppressant pholcodine after an investigation linked the ingredient with an increased risk of potentially fatal anaphylactic reactions to other medicines used during general anaesthesia.
The pholcodine-containing products have also been cancelled from the Australian Register of Therapeutic Goods — along with another 11 products not currently on shelves — meaning they will no longer be able to be lawfully supplied in Australia.
The recall affects a range of cough syrups and lozenges manufactured by Benadryl, Codral, Chemists' Own, TerryWhite, Priceline, Difflam, Bisolvon, Duro-Tuss and others.
Pholcodine — an opioid that works directly in the brain to suppress the cough reflex by reducing nerve signals — has been in use since the 1950s, and is contained in a variety of over-the-counter medicines.
In addition to cough syrups and lozenges aimed at treating dry coughs, it can be found in products that treat cold and flu symptoms more broadly.
Anaesthetists have been calling on the TGA to recall the products for years, citing evidence that showed differing rates of anaphylaxis in Norway, which had high pholcodine use before withdrawing it from the market in 2007, and Sweden, where it was not marketed since the late 1980s.
In issuing the recall, the TGA said it now suspected 50 cases in Australia of reported adverse reactions to neuromuscular blockers — medicines used as muscle relaxants during general anaesthesia — were in fact pholcodine-related anaphylactic reactions, including one case in which the patient died.
The head of the TGA, Dr John Skerritt, said the broad recall was being undertaken because it was difficult to accurately ascertain who has taken medicines containing pholcodine in the 12 months before undergoing surgery.
"While surgical facilities may ask about which prescription medicines a patient is taking, they may not ask about over-the-counter products," Dr Skerritt said.
"Some patients undergoing emergency surgery may not be in a position to talk to their anaesthetist at all."
He said health professionals who currently have patients scheduled to undergo general anaesthesia should check whether patients have used pholcodine in the past 12 months.
What do consumers need to do?
Anyone in possession of over-the-counter cold and flu medication, in particular lozenges or syrups, should check the ingredients to see if they contain pholcodine.
If they do, people should ask their doctor or pharmacist to suggest an alternative.
If someone suspects they have taken pholcodine over the past 12 months and is due to undergo general anaesthesia, they should tell their health professional prior to the procedure.
A full list of the recalled products can be found at the bottom of this article.
'It's amazing that it lasted so long'
Professor Ian Rae, an expert on chemicals in the environment at the University of Melbourne's School of Chemistry, says the TGA "acted appropriately" in taking pholcodine products off the market.
"It's surprising that [concerns] about its side effects have taken so long to emerge," Professor Rae said.
"It's amazing that it lasted so long, but then, it's only in recent years that use of another widely used opiate, codeine, has been restricted.
"Another opiate bites the dust."
The head of Flinders University's Clinical Epidemiology Research Group, Dr Ashley Hopkins, agreed that the decision to deregister pholcodine was a welcome one, saying it was based on strong scientific evidence.
"These reactions can occur even in patients who have no history of allergy to any other medication," Dr Hopkins said.
"As healthcare professionals, our primary concern is the safety and wellbeing of our patients and removing a medication that poses such a significant risk is a necessary step in ensuring that patient safety is maintained."
What products are covered by the recall?
Here is the full list of recalled products, as supplied to the ABC by the Therapeutic Goods Administration:
- APOHEALTH DRY TICKLY COUGH RELIEF pholcodine 1mg/mL oral liquid bottle (new formulation)
- APOHEALTH DRY TICKLY COUGH RELIEF FORTE pholcodine 4mg/mL oral liquid bottle
- APOHEALTH DRY TICKLY COUGH RELIEF pholcodine 1mg/mL oral liquid bottle
- CHEMISTS' OWN DRY TICKLY COUGH FORTE pholcodine 4mg/mL oral liquid bottle (new formulation)
- CHEMISTS' OWN DRY COUGH FORTE pholcodine 3mg/mL oral liquid bottle
- CHEMISTS' OWN DRY COUGH REGULAR pholcodine 1mg/mL oral liquid bottle
- CHEMISTS' OWN DRY COUGH pholcodine 1mg/mL oral liquid bottle
- APOHEALTH DRY COUGH RELIEF PE & NASAL DECONGESTANT oral liquid bottle
- BLOOMS THE CHEMIST DRY COUGH RELIEF & NASAL DECONGESTANT PE oral liquid bottle
- CHEMISTS' OWN KIDDICOL FOR CHILDREN COUGH & COLD oral liquid bottle
- CHEMISTS' OWN DRY COUGH PLUS NASAL DECONGESTANT PE oral liquid bottle
- CHEMISTS' OWN KIDDICOL CHILDREN'S COUGH MIXTURE oral liquid bottle
- LOGICIN DRY COUGH pholcodine 1mg/mL oral liquid bottle
- DURO-TUSS DRY COUGH LIQUID FORTE pholcodine 3mg/mL oral liquid bottle (new formulation)
- DURO-TUSS DRY COUGH LIQUID 6 YEARS+ pholcodine 1mg/mL oral liquid bottle (New Formula)
- DURO-TUSS DRY COUGH LOZENGES lemon flavour blister pack
- DIFFLAM PLUS DRY COUGH + ANTIBACTERIAL + ANTI-INFLAMMATORY pineapple lime flavour lozenge blister pack
- DIFFLAM PLUS DRY COUGH + ANTIBACTERIAL + ANTI-INFLAMMATORY honey lemon ginger flavour lozenge blister pack
- DURO-TUSS DRY COUGH LIQUID PLUS NASAL DECONGESTANT oral liquid bottle
- DURO-TUSS DRY COUGH LOZENGES orange flavour blister pack
- DURO-TUSS COUGH LIQUID EXPECTORANT oral liquid bottle
- DURO-TUSS PE DRY COUGH LIQUID + NASAL DECONGESTANT oral liquid bottle
- DIFFLAM PLUS DRY COUGH + ANTIBACTERIAL + ANTI-INFLAMMATORY blackcurrant flavour lozenge blister pack
- BENADRYL DRY, TICKLY COUGH FORTE pholcodine 4mg/mL oral liquid bottle
- CODRAL DRY COUGH FORTE STRENGTH pholcodine 4mg/mL oral liquid bottle
- PRICELINE PHARMACY DRY COUGH RELIEF pholcodine 5mg/5mL oral liquid bottle
- PHARMACY HEALTH DRY COUGH RELIEF pholcodine 5mg/5mL oral liquid bottle
- TERRYWHITE CHEMMART DRY COUGH RELIEF pholcodine 1mg/mL oral liquid bottle
- TERRYWHITE CHEMMART DRY COUGH FORTE pholcodine 4mg/mL oral liquid bottle
- PHARMACY CHOICE PHOLCODINE DRY FORTE 4mg/mL oral liquid bottle
- PRICELINE PHARMACY DRY TICKLY COUGH MIXTURE pholcodine 1mg/mL bottle
- PHARMACY HEALTH DRY TICKLY COUGH MIXTURE pholcodine 1mg/mL bottle
- SOUL PATTINSON DRY TICKLY COUGH MEDICINE pholcodine 1mg/mL oral liquid bottle
- PHARMACY CHOICE DRY COUGH RELIEF FORTE pholcodine 20mg/5mL oral liquid bottle
- PHARMACY CHOICE DRY COUGH RELIEF pholcodine 5mg/5 mL oral liquid bottle
- TERRYWHITE CHEMMART DRY COUGH RELIEF FORTE pholcodine 20mg/5mL oral liquid bottle
- NOUMED DRY COUGH LIQUID FORTE pholcodine 4mg/mL oral liquid bottle
- NOUMED DRY COUGH LIQUID pholcodine 1mg/mL oral liquid bottle
- PHARMACY CHOICE DRY TICKLY COUGH MEDICINE pholcodine 1mg/mL oral liquid bottle
- TERRYWHITE CHEMMART DRY COUGH RELIEF pholcodine 5mg/5mL oral liquid bottle
- AMCAL DRY COUGH FORTE pholcodine 4mg/mL oral liquid bottle
- AMCAL DRY COUGH MIXTURE pholcodine 1mg/mL oral liquid bottle
- PHARMACY HEALTH DRY COUGH RELIEF FORTE pholcodine 4mg/mL oral liquid bottle
- PRICELINE PHARMACY DRY COUGH RELIEF FORTE pholcodine 4mg/mL oral liquid bottle
