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.
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.
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.
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.
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))