The TGA has cancelled 55 pholcodine-containing products amid concerns of anaphylactic reactions during anaesthesia.
All over-the-counter products containing the common cough reliever pholcodine have been cancelled and recalled from shelves amid concerns that the drug increases the risk of anaphylactic reactions during anaesthesia.
The TGA has cancelled 55 cough syrups and lozenges containing the morphine derivative, as the agency reported that 50 people had had suspected pholcodine-related anaphylactic reactions to neuromuscular blockers after taking pholcodine, and one person had died.
Of the 55 products in Australia that contain pholcodine, 44 are still available in pharmacies and need to be recalled, said the TGA, which published the full list of products to be recalled.
TGA head Adjunct Professor John Skerritt said health professionals should ask any patients scheduled to undergo general anaesthesia whether they had taken pholcodine products in the previous 12 months.
Professor Skerritt said it could be difficult to predict who may be at risk of anaphylaxis during anaesthesia, and some patients may not know if they had taken pholcodine medicines recently.
“Some patients undergoing emergency surgery may not be in a position to talk to their anaesthetist at all,” he 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.”
Professor Skerritt said there were safer alternatives to treat a dry cough.
“Another opiate bites the dust,” said organic chemist Professor Ian Rae from the University of Melbourne.
Professor Rae said pholcodine was a derivative of morphine and had been used to relieve dry cough since the 1950s.
“It’s surprising that concern about its side effects have taken so long to emerge,” he said in a statement.
Professor Rae said the Merck Index notes that pholcodine abuse could lead to habituation or addiction, but does not mention anaphylaxis risk.
Dr Ashley Hopkins, head of the Clinical Epidemiology Research Group at Flinders University, saidpholcodine-relatedanaphylactic reactions could occur in patients with no previous history of allergy to any other medication.
“The decision to remove pholcodine from the market is based on strong scientific evidence, including several studies that have shown a clear link between the use of pholcodine and an increased risk of anaphylaxis,” he said.
Molecular pharmacologist Dr Ian Musgrave said anaphylaxis to neuromuscular blocking agents after taking pholcodine was rare, but potentially fatal.
“Since it can be very difficult to determine if someone about to undergo anaesthesia has taken a pholcodine-containing medicine, the risk was determined to be too great given the minimal benefit of pholcodine for it to remain a registered medicine,” said Dr Musgrave, from the University of Adelaide.
Since pholcodine was withdrawn in Norway, cases of anaphylaxis to neuromuscular blocking agents fell in the following three years, he said.
The European Medicines Agency has recommended that marketing authorisation for these products is withdrawn in Europe.
The TGA said it had received 50 reports of suspected pholcodine-related anaphylactic reactions to neuromuscular blockers in Australia, including one fatality.
