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Safety concerns relating to pholcodine-containing dry cough products


Following a safety investigation by the Therapeutic Goods Administration (TGA), pholcodine containing medicines are being cancelled from the Australian Register of Therapeutic Goods (ARTG) and those currently on pharmacy shelves are being recalled from pharmacies.

The cancellation and recall actions are being taken because of a link between pholcodine-containing medicines and an increased risk of anaphylactic reactions to certain medicines used as muscle relaxants during general anaesthesia called neuromuscular blocking agents (NMBAs). Further information about the safety alert and recall can be found on TGA’s website:

Providing the community with safe and effective products is iNova Pharmaceutical’s top priority. We are working closely with the TGA to recall our affected products from pharmacies and meet all our regulatory requirements on this matter.

Should consumers have pholcodine containing medicines at home, it is advised that they speak with their pharmacist or doctor regarding a suitable alternative treatment.

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Consumers that want to report any adverse events relating to an iNova product, please contact

Frequently Asked Questions

What is Pholcodine?

Pholcodine is an effective cough-suppressant that has been recommended by healthcare professionals and used around the world since the 1950s for the treatment of dry coughs. Pholcodine is not used for the treatment of ‘wet’ or ‘chesty’ coughs.

Why are pholcodine-containing medicines being recalled/withdrawn?

On 28 February, the Therapeutic Goods Administration (TGA) announced a recall of products containing pholcodine in Australia. The recall will be a Class II Retail Level recall must commence by 8 March. The TGA further announced that the registrations for pholcodine-containing products will ultimately be cancelled from the Australian Register of Therapeutic Goods (ARTG), effective from 29 March.

The TGA’s decision to recall pholcodine containing medicines is linked to a recently concluded French clinical study (the ALPHO Study) which reviewed a possible association between pholcodine and very rare but serious anaphylactic reactions to medicines called neuromuscular blocking agents (NMBAs) used in anaesthesia.

Data from the ALPHO study indicates that the use of pholcodine in the 12 months leading up to anaesthesia using NMBAs slightly increases the risk of developing an anaphylactic reaction, noting that the risk of anaphylactic reactions to NMBAs during anaesthesia is already very low. The relationship between pholcodine and anaphylactic reactions to NMBAs has been hypothesised over the last decade, however, until the ALPHO study no association had previously been established in any clinical study globally. There is still no evidence showing causal risk.

What should you do if you have pholcodine-containing medicines at home. Can you consume them?

Consumers should:

  • check if any of your over-the-counter cold and flu or cough medicines contain pholcodine, including in cough lozenge or syrup products
  • speak to your doctor or pharmacist about other treatments
  • let their anaesthetist know if you have, or could have, taken pholcodine-containing medicines in the last 12 months, before surgery.
Are all Duro-Tuss/Difflam products affected?

No, only a small portion of the Duro-Tuss and Difflam ranges are affected, and these are the ones that contain pholcodine, which are used to treat a dry cough. You can find the full list of affected and non-affected products here.

What should you do if you have taken a pholcodine-containing medicine in the last 12 months and are due to have surgery soon. Is it safe to undergo anaesthesia?

If you are due to have anaesthesia, where a neuromuscular blocking agent will be used, it is important to advise your healthcare professional and anaesthetist of all medicines you have taken in the last 12 months, including those that are purchased over the counter.

Do you have an alternative dry cough product consumers can now select?

Consumers should seek advice from their doctor or pharmacist for an appropriate recommendation for their dry cough.

iNova has other products for the relief of dry coughs including:

  • Nyal Dry Cough Medicine (containing Pentoxyverine Citrate)
  • Duro-Tuss Relief Dry Cough Liquid (containing Althaea officinalis (Marshmallow root extract))

Please complete the below contact form if you have a query relating to the recent recall of Pholcodine containing products.

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