More than 50 products, including popular over-the-counter cough syrups and lozenges, are being pulled from shelves in Australia due to an increased risk of a potentially life-threatening reaction.

After a safety investigation from the Therapeutic Goods Administration (TGA) it has cancelled 55 products containing pholcodine from the Australian Register of Therapeutic Goods. Any of the products containing the ingredient that are currently on pharmacy shelves are being recalled, and they include cough syrups and lozenges manufactured by Benadryl, Codral, Chemists’ Own, TerryWhite, Priceline, Difflam, Bisolvon, Duro-Tuss and more.

Pholcodine has been used in adults and children to treat dry coughs, most commonly in cough syrups and lozenge products.

The TGA says there is a link between medicines containing pholcodine and an ‘increased risk of anaphylactic reactions (a sudden, severe and life-threatening allergic reaction) to certain medicines used as muscle relaxants during general anaesthesia (called neuromuscular blocking agents)’.

 

According to the TGA pholcodine is also used in combination with other medicines in products that treat the symptoms of cold and flu.

The concern is that some patients who are having surgery may have recently taken cough syrup containing pholcodine.

TGA Head Adjunct Professor John Skerritt said: “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.

“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.

“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.”

Dr Skerritt said if you need general anaesthetic and you’ve taken pholcodine in the past 12 months you should talk to your health professional.

The TGA’s investigation followed a review by the European Medicines Agency (EMA) which recommended the withdrawal of marketing authorisations for these products in Europe.

According to the TGA, “The European findings were supported by a Western Australian study which also showed that pholcodine was a risk factor. Up to 9 February this year, the TGA has also received 50 reports of Australian cases of suspected pholcodine-related anaphylactic reactions to neuromuscular blockers, including one fatality.”

What should you do?

The TGA recommends that you check whether any of your over-the-counter cold and flu medicines contain pholcodine. It’s usually used in cough lozenges or syrup products, but can also be found in other medicines. If the product you’re looking at does contain pholcodine, ask your pharmacist for an alternative.

Full list of recalled products:

The full list of recalled products as supplied by the TGA:

1. APOHEALTH DRY TICKLY COUGH RELIEF pholcodine 1mg/mL oral liquid bottle (new formulation)
2. APOHEALTH DRY TICKLY COUGH RELIEF FORTE pholcodine 4 mg/mL oral liquid bottle
3. APOHEALTH DRY TICKLY COUGH RELIEF pholcodine 1mg/mL oral liquid bottle
4. CHEMISTS’ OWN DRY TICKLY COUGH FORTE pholcodine 4 mg/mL oral liquid bottle (new formulation)
5. CHEMISTS’ OWN DRY COUGH FORTE pholcodine 3mg/mL oral liquid bottle
6. CHEMISTS’ OWN DRY COUGH REGULAR pholcodine 1 mg/mL oral liquid bottle
7. CHEMISTS’ OWN DRY COUGH pholcodine 1mg/mL oral liquid bottle
8. APOHEALTH DRY COUGH RELIEF PE & NASAL DECONGESTANT oral liquid bottle
9. BLOOMS THE CHEMIST DRY COUGH RELIEF & NASAL DECONGESTANT PE oral liquid bottle
10. CHEMISTS’ OWN KIDDICOL FOR CHILDREN COUGH & COLD oral liquid bottle
11. CHEMISTS’ OWN DRY COUGH PLUS NASAL DECONGESTANT PE oral liquid bottle
12. CHEMISTS OWN KIDDICOL CHILDREN’S COUGH MIXTURE oral liquid bottle
13. LOGICIN DRY COUGH Pholcodine 1mg/mL oral liquid bottle
14. DURO-TUSS DRY COUGH LIQUID FORTE pholcodine 3 mg/mL oral liquid bottle (new formulation)
15. DURO-TUSS DRY COUGH LIQUID 6 YEARS + pholcodine 1mg/mL oral liquid bottle (New Formula)
16. DURO-TUSS DRY COUGH LOZENGES lemon flavour blister pack
17. DIFFLAM PLUS DRY COUGH + ANTIBACTERIAL + ANTI-INFLAMMATORY pineapple lime flavour lozenge blister pack
18. DIFFLAM PLUS DRY COUGH + ANTIBACTERIAL + ANTI-INFLAMMATORY honey lemon ginger flavour lozenge blister pack
19. DURO-TUSS DRY COUGH LIQUID PLUS NASAL DECONGESTANT oral liquid bottle
20. DURO-TUSS DRY COUGH LOZENGES orange flavour blister pack
21. DURO-TUSS COUGH LIQUID EXPECTORANT oral liquid bottle
22. DURO-TUSS PE DRY COUGH LIQUID + NASAL DECONGESTANT oral liquid bottle
23. DIFFLAM PLUS DRY COUGH + ANTIBACTERIAL + ANTI-INFLAMMATORY blackcurrant flavour lozenge blister pack
24. BENADRYL DRY, TICKLY COUGH FORTE pholcodine 4mg/mL oral liquid bottle
25. CODRAL DRY COUGH FORTE STRENGTH pholcodine 4mg/mL oral liquid bottle
26. PRICELINE PHARMACY DRY COUGH RELIEF pholcodine 5mg/5mL oral liquid bottle
27. PHARMACY HEALTH DRY COUGH RELIEF pholcodine 5mg/5mL oral liquid bottle
28. TERRYWHITE CHEMMART DRY COUGH RELIEF pholcodine 1 mg/mL oral liquid bottle
29. TERRYWHITE CHEMMART DRY COUGH FORTE pholcodine 4 mg/ mL oral liquid bottle
30. PHARMACY CHOICE PHOLCODINE DRY FORTE 4mg/mL oral liquid bottle
31. PRICELINE PHARMACY DRY TICKLY COUGH MIXTURE pholcodine 1mg/mL bottle
32. PHARMACY HEALTH DRY TICKLY COUGH MIXTURE pholcodine 1mg/mL bottle
33. SOUL PATTINSON DRY TICKLY COUGH MEDICINE pholcodine 1 mg/mL oral liquid bottle
34. PHARMACY CHOICE DRY COUGH RELIEF FORTE pholcodine 20 mg / 5 mL oral liquid bottle
35. PHARMACY CHOICE DRY COUGH RELIEF pholcodine 5 mg / 5 mL oral liquid bottle
36. TERRYWHITE CHEMMART DRY COUGH RELIEF FORTE pholcodine 20 mg / 5 mL oral liquid bottle
37. NOUMED DRY COUGH LIQUID FORTE pholcodine 4 mg/mL oral liquid bottle
38. NOUMED DRY COUGH LIQUID pholcodine 1 mg/mL oral liquid bottle
39. PHARMACY CHOICE DRY TICKLY COUGH MEDICINE pholcodine 1 mg/mL oral liquid bottle
40. TERRYWHITE CHEMMART DRY COUGH RELIEF pholcodine 5mg/5mL oral liquid bottle
41. AMCAL DRY COUGH FORTE pholcodine 4mg/mL oral liquid bottle
42. AMCAL DRY COUGH MIXTURE pholcodine 1 mg/mL oral liquid bottle
43. PHARMACY HEALTH DRY COUGH RELIEF FORTE pholcodine 4 mg/mL oral liquid bottle
44. PRICELINE PHARMACY DRY COUGH RELIEF FORTE pholcodine 4 mg/mL oral liquid bottle

 

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