Check for pholcodine use before general anaesthesia

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'.

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.

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Medicines Safety Update is written by staff from the Pharmacovigilance Branch.

Editor: Ms Elspeth Kay

Deputy Editor: Dr Fiona Mackinnon

Contributors: Mr Michael Pittman