Summary
Health professionals are reminded to check whether patients scheduled to undergo general anaesthesia with neuromuscular blocking agents (NMBAs) have used products containing pholcodine in the previous 12 months. This is due to a suspected link to an increased risk of potentially life-threatening anaphylactic reactions.
Pholcodine has been used in adults and children to treat non-productive cough and is most commonly used in non-prescription cough syrups and lozenge products. It has also been used in combination with other active substances in products that treat the symptoms of cold and flu.
What’s new in this article
The Therapeutic Goods Administration (TGA) has recently made a decision to cancel the registration of pholcodine-containing medicines in Australia. All stock of pholcodine-containing products remaining on pharmacy shelves has also been recalled.
The TGA decision followed a review by the European Medicines Agency (EMA) recommending the withdrawal of marketing authorisations for these products in Europe.
Further information about this cancellation was published in a safety alert on our website, including a list of the 44 pholcodine-containing products on pharmacy shelves when the decision was made.
What should health professionals do
Health professionals are encouraged to discuss this safety issue with patients and to advise them to stop taking any pholcodine-containing medicines that they have. Recommend appropriate alternatives to treat cough and other cold and flu symptoms.
If a patient is scheduled to undergo general anaesthesia with NMBAs, check whether they have used pholcodine in the previous 12 months. Be aware of the risk of anaphylactic reactions in these patients.
It’s important to reassure patients this risk only applies to general anaesthesia containing neuromuscular blocking agents and not to local anaesthetics.
To see a list of the all the recalled products, go to our System for Australian Recall Actions (SARA) database. Select the product type ‘Medicine’ from the drop-down menu and search using the term ‘pholcodine’.
What to report? You don’t need to be certain, just suspicious!
The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.
We particularly request reports of:
- all suspected reactions to new medicines (look for the Black Triangle ▼ in PI and CMI documents – this symbol identifies medicines that are new or being used differently)
- all suspected medicines interactions
- suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.
To report a suspected side effect of for more information about reporting, go to our To report a suspected side effect of for more information about reporting, go to our ‘Report problem or side effect‘ webpage or contact the TGA’s Pharmacovigilance Branch [email protected].
Disclaimer
Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional’s judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.
© Commonwealth of Australia 2023
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to [email protected].
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For correspondence or further information about Medicines Safety Update, contact the TGA’s Pharmacovigilance Branch at [email protected].
Medicines Safety Update is written by staff from the Pharmacovigilance Branch.
Editor: Ms Elspeth Kay
Deputy Editor: Dr Fiona Mackinnon
Contributors: Mr Michael Pittman
