Published: 25 September 2023
Safety Information
Alert Communication
Consent to distribute pholcodine-containing medicines will be revoked on 12 January 2024
25 September 2023
Following Medsafe’s review of pholcodine-containing medicines and on advice from the Medicines Adverse Reactions Committee, the Minister’s delegate has decided to revoke the consent of pholcodine-containing medicines from 12 January 2024.
The decision to revoke consent (withdraw the medicine) was made on safety grounds.
There is a small risk that taking pholcodine may predispose patients to anaphylaxis (a rare but life-threatening allergic reaction) during surgery. Patients who require surgery involving neuromuscular blocking agents (NMBAs) may be more likely to experience anaphylaxis if they have previously taken pholcodine.
Products affected
Advice for consumers and caregivers
Information for healthcare professionals
Further information
Useful links
Products affected
| Product name | Sponsor |
|---|---|
| Difflam Plus Dry Cough + Antibacterial + Anti-inflammatory Lozenge, Blackcurrant Flavour Sugar Free | iNova Pharmaceuticals (New Zealand) Limited |
| Duro-Tuss Cough Liquid Expectorant Oral solution, 0.8mg/1mg per mL | iNova Pharmaceuticals (New Zealand) Limited |
| Duro-Tuss Dry Cough Lozenge, Lemon and Orange flavours | iNova Pharmaceuticals (New Zealand) Limited |
| Duro-Tuss Dry Cough Liquid Forte Oral solution, 3 mg/mL | iNova Pharmaceuticals (New Zealand) Limited |
| Duro-Tuss Phenylephrine PE Dry Cough + Nasal Decongestant Oral solution | iNova Pharmaceuticals (New Zealand) Limited |
| Duro-Tuss Dry Cough Liquid Regular Oral solution, 1 mg/mL, New Formula | iNova Pharmaceuticals (New Zealand) Limited |
| Duro-Tuss Dry Cough Liquid Junior Oral solution, 1 mg/mL, New Formula (not available) | iNova Pharmaceuticals (New Zealand) Limited |
| Difflam Plus Cough Sore Throat Lozenges Lozenge, Sugar Free Honey, Lemon & Ginger, Pineapple & Lime flavours (not available) | iNova Pharmaceuticals (New Zealand) Limited |
| Pholcodine Linctus BP Linctus, 5 mg/5mL, (AFT) | AFT Pharmaceuticals Ltd |
| Strong Pholcodine Linctus BP Linctus, 10 mg/5mL, Pinewood | AFT Pharmaceuticals Ltd |
| Stubborn Dry Tickly Cough (Pharmacy Health) Linctus, 2 mg/mL (not available) | Noumed Pharmaceuticals Limited |
Advice for consumers and caregivers
- Recent use of pholcodine-containing medicines may increase your risk of an anaphylactic reaction (a rare but life-threatening allergic reaction) during surgery.
- Let your anaesthetist know if you have recently used pholcodine. Your anaesthetist will be able to answer any questions you may have relating to this risk.
- Pholcodine-containing medicines will no longer be available from pharmacies from 12 January 2024. If you have a dry cough, talk to your pharmacist for advice on treatment.
- These medicines are not being recalled, you do not have to return them.
- Talk to your pharmacist if you are unsure about the ingredients of cough and cold medicines.
Information for healthcare professionals
- Pharmacists may continue to sell pholcodine-containing medicines until 11 January 2024.
- Pholcodine will not be recalled to help manage the winter cold season.
- Inform consumers about the small but potential risk of perioperative anaphylaxis to NMBAs from prior pholcodine exposure.
- Selling pholcodine-containing medicines from 12 January 2024 is not permitted and will be in breach of section 20 of the Medicines Act 1981.
- Discuss appropriate treatment alternatives for patients who present with a new or existing dry cough.
- Ask patients scheduled to undergo general anaesthesia involving NMBAs whether they have recently used medicines containing pholcodine.
Further information
Pholcodine, a medicine found in some cold and flu cough syrups and lozenges, is used to relieve a dry cough in adults and children aged six years and older. Currently, pholcodine-containing medicines can be purchased from a pharmacist without a doctor’s prescription.
A recent study found that exposure to pholcodine in the last 12 months was associated with an increased risk of anaphylaxis in people who receive general anaesthesia involving neuromuscular blocking agents (NMBAs)1. Regulators in the United Kingdom, European Union and Australia have withdrawn pholcodine-containing medicines from the market as a precautionary measure.
In April 2023, Medsafe initiated a review on the safety and efficacy of pholcodine to consider whether pholcodine-containing medicines should continue to be available in New Zealand. As part of the review, Medsafe sought expert advice from the Medicines Adverse Reactions Committee in June 2023. The available evidence suggested that both the risk of anaphylaxis to NMBAs themselves, and risk of NMBA associated anaphylaxis in people who have taken pholcodine remains very small. However, anaphylaxis is a serious and life-threatening event. The Minister’s delegate considered that there were no suitable measures available in New Zealand to mitigate this risk and so decided to revoke the consent of pholcodine-containing medicines under section 35 of the Medicines Act 1981.
The revocation will occur on 12 January 2024 to avoid the risk that withdrawal of a medicine for dry cough at short notice during the winter months will place undue pressure on the health system. This will also allow sufficient time for clinical guidelines and treatment pathways to be updated.
Useful links
- Review of pholcodine-containing medicines – Medsafe’s original monitoring communication, 26 April 2023
- Medsafe’s review on the safety and efficacy of pholcodine
- Minutes of the 194th Medicines Adverse Reactions Committee meeting, 8 June 2023
Reference
- Mertes PM, Petitpain N, Tacquard C, et al. 2023. Pholcodine consumption increases the risk of perioperative anaphylaxis to neuromuscular blocking agents: the ALPHO case-control study. British Journal of Anaesthesia. URL: https://doi.org/10.1016/j.bja.2023.02.026 (accessed 29 March 2023).
