Published: 26 April 2022
Safety Information
Monitoring communication
Review of pholcodine-containing medicines – Provide your feedback by 8 May 2023
Medsafe is reviewing whether pholcodine-containing medicines should continue to be available in New Zealand following withdrawal in other countries. As part of this review, we are seeking feedback from consumers and healthcare professionals on the use of pholcodine for the symptomatic relief of dry (non-productive) coughs. Please email your feedback to the Manager, Clinical Risk Management, Medsafe (medsafeadrquery@health.govt.nz). Feedback must be provided by 8 May 2023 to be considered in the Medsafe review.
Products affected
Additional information
References
Products affected
| Product name | Sponsor |
|---|---|
| Difflam Plus Cough Sore Throat Lozenges Lozenge, Sugar Free Honey, Lemon & Ginger Flavour | iNova Pharmaceuticals (New Zealand) Limited |
| Difflam Plus Cough Sore Throat Lozenges Lozenge, Sugar Free Pineapple & Lime Flavour | iNova Pharmaceuticals (New Zealand) Limited |
| 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) | iNova Pharmaceuticals (New Zealand) Limited |
| Duro-Tuss Dry Cough Lozenge, (Orange) | iNova Pharmaceuticals (New Zealand) Limited |
| Duro-Tuss Dry Cough Liquid Forte Oral solution, 3 mg/mL | iNova Pharmaceuticals (New Zealand) Limited |
| Duro-Tuss Dry Cough Liquid Junior Oral solution, 1 mg/mL, New Formula | 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 Phenylephrine PE Dry Cough + Nasal Decongestant Oral solution | 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 |
| Pholcodine Linctus BP Linctus, 5 mg/5mL, (PSM) (not available) | Noumed Pharmaceuticals Limited |
| Pholcodine Strong BP Linctus, 10 mg/5mL, (PSM) (not available) | Noumed Pharmaceuticals Limited |
| Stubborn Dry Tickly Cough (Pharmacy Health) Linctus, 2 mg/mL (not available) | Noumed Pharmaceuticals Limited |
Additional information
Why is Medsafe reviewing pholcodine-containing medicines?
Pholcodine, a medicine found in some cold and flu cough syrups and lozenges, is used to relieve a dry (non-productive) cough. Pholcodine is classified as a pharmacist-only (restricted) medicine. This means that it can be purchased from a pharmacist without a doctor’s prescription.
A recent study found that exposure to pholcodine leads to an increased risk of anaphylaxis (a rare but life-threatening allergic reaction) in patients who receive general anaesthesia involving neuromuscular blocking agents (NMBAs).1 Internationally, some regulators have removed pholcodine-containing medicines from the market2-4.
To consider next steps, Medsafe has initiated a review of the efficacy and safety of pholcodine. Expert advice will also be sought from the Medicines Adverse Reactions Committee (MARC).
Recent regulatory actions related to pholcodine in New Zealand
The MARC reviewed the safety and efficacy of pholcodine-containing medicines in December 2019. At that time, it was considered that there was insufficient evidence to indicate that these medicines should be withdrawn. The MARC recommended that the Medicines Classification Committee (MCC) consider reclassifying pholcodine-containing medicines to a more restricted classification. In October 2020, the MCC recommended that pholcodine-containing medicines be reclassified to a restricted (pharmacist-only) medicine, and this came into effect in December 2022.
The report presented to the MARC and the Committee meeting minutes are published on the Medsafe website.
- Minutes of the 180th Medicines Adverse Reactions Committee meeting, 5 December 2019.
- Report presented to the Medicines Adverse Reactions Committee.
- Reclassification of pholcodine.
References
- 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).
- European Medicines Agency. 2022. EMA recommends withdrawal of pholcodine medicines from EU market. 2 December 2022. URL: ema.europa.eu/en/news/ema-recommends-withdrawal-pholcodine-medicines-eu-market (accessed 3 April 2023).
- Therapeutic Goods Administration. 2023. About pholcodine cough medicines cancelled by the TGA and recalled from pharmacies for safety reasons. 6 March 2023. URL: tga.gov.au/safety/information-about-specific-safety-alerts-and-recalls/about-pholcodine-cough-medicines-cancelled-tga-and-recalled-pharmacies-safety-reasons (accessed 3 April 2023).
- Medicines and Healthcare products Regulatory Agency. 2023. In Drug Safety Update: Pholcodine-containing cough and cold medicines: withdrawal from UK market as a precautionary measure. 14 March 2023. URL: gov.uk/drug-safety-update/pholcodine-containing-cough-and-cold-medicines-withdrawal-from-uk-market-as-a-precautionary-measure (accessed 3 April 2023).
