Submissions and TGA response: Miconazole and fluconazole: proposed additional advisory statements for medicines

14 September 2018

The TGA would like to thank the respondents who have submitted written comments or made submissions in response to the consultation: miconazole and fluconazole: proposed advisory statements for medicines.

Submissions received

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Five submissions were received. The following submissions provided consent for publication on the TGA website:

The respondents in general supported the new warning statements, but most respondents proposed simplifications and other modifications.

Summary of issues reported and TGA response

The following sets out in brief the issues identified from the submissions received, and the TGA's response.

1. Advisory statement regarding use when taking warfarin

Summary of issue

Three respondents considered the statement was unnecessarily long and that "Ask your doctor or pharmacist before use if you are taking warfarin", or similar, would be sufficient. In support of this, respondents variously noted the following points: warfarin patients were already counselled in taking other medicines; S3 scheduling meant pharmacist counselling occurred; the proposed statement may be alarmist to other consumers and was not consistent with Medsafe-required warnings, an important aspect for industry; further information could instead be included in the CMI.

Pharmaceutical Society of Australia considered that reference to "a medicine used to thin the blood" should be more accurately expressed, for example as "a medicine which helps to prevent blood clots forming and treats existing clots".

Pharmaceutical Society of Australia considered that the proposed warfarin advisory statement was inadequate for miconazole topical oral use and that miconazole topical oral use should instead be contraindicated when taking warfarin.

TGA response

The TGA agrees that the warning should be simplified to "Ask your doctor or pharmacist before use if you are taking warfarin". This warning is also considered appropriate for miconazole topical oral use, rather than requiring an absolute contraindication, noting that miconazole topical oral use together with warfarin may be necessary in clinical practice and that consultation with a pharmacist is required prior to dispensing.

2. Advisory statement for fluconazole regarding use in pregnancy

Summary of issue

Two respondents did not support the proposed wording "Do not use if pregnant or likely to become pregnant", instead proposing "Do not use if you are pregnant or trying to become pregnant". They noted that "trying to become pregnant" was consistent with the RASML warning for NSAIDS and that this wording had been adopted in place of "likely" after the TGA acknowledged that the words "likely to become pregnant" may be unclear and potentially confusing to consumers.

TGA response

The warning will be amended to "Do not use if pregnant or [trying/likely] to become pregnant" to allow for the use of either word, or both.

3. Other issues

Summary of issues

A respondent suggested that these changes should be included in the Product Information (PI) and Consumer Medicines Information (CMI) for these medicines, and that all medicine boxes should contain a CMI leaflet.

One respondent requested a minimum of 18 months, and preferably 2 years, to implement the changes.

TGA response

All of the affected products are S3, and are therefore required to have a PI and CMI. The TGA will continue to check that the PI and CMI documents presented for review include the required advice.

The standard transition time for implementation of RASML warnings is 18 months.

Final proposal

Advisory statements for medicines containing miconazole or fluconazole

The following advisory statements will be included in the Required Advisory Statements for Medicine Labels (RASML) document when it is next updated (the new statements are indicated by green, larger font, with a horizontal line above it).

Column 1
Substance(s)
Column 2
Conditions
Column 3
Required statement(s)
Miconazole
(Entry 1 of 2)
In preparations for vaginal use
  • Seek medical advice before first course of treatment.
  • See a doctor before use if you are pregnant or diabetic.
  • Ask your doctor or pharmacist before use if you are taking warfarin.
  • See a doctor if no better after [Insert number of days as per approved Product Information] days.
  • See a doctor if problem returns.
Miconazole
(Entry 2 of 2)
In preparations for topical oral use
  • Ask your doctor or pharmacist before use if you are taking warfarin.
Fluconazole In oral medicines for treatment of vaginal candidiasis
  • Seek medical advice before first course of treatment.
  • Do not use if pregnant or [trying/likely] to become pregnant.
  • See a doctor before use if you are diabetic.
  • Ask your doctor or pharmacist before use if you are taking warfarin.
  • See a doctor if no better after [Insert number of days as per approved Product Information] days.
  • See a doctor if problem returns.