A safety investigation by the TGA has led to the recall of 55 pharmaceutical products, including popular over-the-counter cough medicines and lozenges. Image source: Pexels.
A safety investigation by the Therapeutic Goods Administration (TGA) has led to the recall of 55 pharmaceutical products, including popular over-the-counter cough medicines and lozenges.
Products from brands such as Bendaryl, Codral, Difflam, Chemist’s Own and TerryWhite are among those being removed from the Australian Register of Therapeutic Goods.
The recalled products contain an ingredient called pholcodine, an opioid that works by reducing nerve signals to suppress the cough reflex.
The ingredient has been in use since the 1950s to treat dry coughs and other cold and flu symptoms.
However, pholcodine has been found to be dangerous when mixed with general anaesthesia, putting putting patients at risk of anaphylactic shock.
The TGA is aware of 50 cases of suspected pholcodine-related anaphylactic reactions within Australia, including one death.
Anaesthetists have sought the recall for years, urging the TGA to restrict the sale of these medicines to be by prescription-only.
Professor Ian Raem an expert from the University of Melbourne’s School of Chemistry, endorsed the decision.
“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.”
TGA Head Adjunct Professor John Skerritt explained why the continued over-the-counter sale of these pholcodine products presented a risk to patients
“Some patients undergoing emergency surgery may not be in a position to talk to their anaesthetist at all. In addition, while surgical facilities may ask about which prescription medicines a patient is taking, they may not ask about over the counter products.”
He offered the following advice to consumers regarding the recall:
“Fortunately, safer alternatives to treat a dry cough are available and consumers should ask their doctor or pharmacist for advice. I urge consumers to check if any of your over-the-counter cold and flu medicines contain pholcodine and, if they do, ask your doctor or pharmacist to suggest an alternative treatment.”
“If you will need general anaesthesia and have taken pholcodine in the past 12 months, I advise you to tell your health professional. Health professionals should also check whether patients scheduled to undergo general anaesthesia have used pholcodine in the previous 12 months.”
The TGA’s investigation followed recommendations by the European Medicines Agency (EMA) which supported similar restrictions in Europe.
You can read the TGA’s full safety alert regarding pholcodine at on their official website.
