Published: 15 February 2017
Consultations
Addition of warning statements on labels of topical miconazole containing medicines available without prescription
Closing date 13 April 2017
The Medicines Adverse Reactions Committee at their 167th meeting recommended that Medsafe update the Label Statements Database to include a compulsory warning statement for miconazole containing products regarding an interaction with warfarin. The purpose of this consultation is to propose labelling requirements for medicines containing miconazole that are available without prescription.
About the consultation
The consultation paper outlines the available information on an interaction between warfarin and medicines containing miconazole. This interaction has been highlighted previously in Prescriber Update. However, the Centre for Adverse Reactions Monitoring (CARM) continues to receive reports of potentially life threatening events in patients taking warfarin and using miconazole containing medicines.
In addition it is noted that label warning statements are required in Australia for miconazole products for vaginal use.
Proposal
Medsafe proposes adding the following statements to the Label Statements Database.
For all topical miconazole products
Either: Do not use [this product] if you are taking warfarin unless a healthcare professional advises you to.
Or: Patients taking warfarin - talk to a healthcare professional before using [this product].
For intravaginal products only.
See a doctor if you are pregnant or diabetic.
Seek medical advice before first course of treatment.
See a doctor if problem returns.
See a doctor if no better after [Insert number of days as per approved Product Information] days.
Invitation to comment
Medsafe is seeking comments and input from interested parties on:
- whether a warning statement about the warfarin interaction is required for all topical miconazole products
- which of the proposed statements is preferred and why
- whether all or some of the warning statements required in Australia for intravaginal products should be included in the Label Statements Database
- a suitable target date for implementation.
Consultation (documents)
Miconazole consultation document (Adobe pdf 275 KB, 13 pages)
Miconazole consultation document (word document 1214 KB, 13 pages)
Timetable
Document released for consultation on 15 February 2017
Interested parties should respond by close of business 13 April 2017
Feedback will be released following consideration of submissions
How to respond
Please complete the Medsafe consultation submission form. Submissions must include full personal or organisation contact details (including address, telephone number or email address).
Link to adobe form (Adobe pdf 60 KB, 3 pages)
Link to word form (Word document 49 KB, 3 pages)
Electronic submissions are preferred and should be emailed to medsafeapplications@health.govt.nz including 'Miconazole warning statements' in the subject line of the email.
Alternatively, hard copy submissions may be posted to:
Product Regulation
Medsafe
PO Box 5013
Wellington 6140
Next Steps
Submissions will be reviewed by Medsafe and feedback will be provided on the Medsafe website. Input into this consultation will be used to help inform the need for label statements for OTC miconazole containing medicines.
Confidentiality
All submissions may be placed on the Medsafe website unless marked confidential. Any confidential material contained within your submission should be clearly marked 'IN CONFIDENCE'. Reasons for a claim of confidentiality must be included in the space provided on the submission coversheet. These reasons must meet Official Information Act 1982 requirements if the submission (or part thereof) is not to be displayed. Official Information Act criteria.
For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the Medsafe website. In addition, a list of parties making submissions may be published.
If you do not wish to be identified with your submission, or if you do not wish your submission to be associated with a party, you must specifically request this in the space provided on the submission coversheet.
Enquiries
Any questions relating to this consultation should be directed via email to: medsafeapplications@health.govt.nz
