Published: 1 June 2017

Consultations

Outcome of consultation on addition of warning statements on labels of topical miconazole containing medicines available without prescription

About the consultation

In February 2017 Medsafe published a consultation on addition of warning statements on labels of topical miconazole containing medicines available without prescription.  The consultation sought feedback on the proposals by 13 April 2017.  Medsafe would like to thank everyone who took the time to prepare a submission.

Submissions received

Submissions received in response to the consultation are published below:

Selwyn Foundation (pdf 445 KB, 1 page)

Christchurch GP (pdf 448 KB, 3 pages)

Johnson & Johnson (pdf 3101 KB, 7 page)

Mylan New Zealand Limited (pdf 1857 KB, 3 page)

General Practitioner (pdf 27 KB, 1 page)

Note: submissions have had personal information removed

All submissions have been reviewed by Medsafe.

Consultation feedback

The consultation asked whether there should be a warning statement about an interaction with warfarin on all topical miconazole containing products.

Two submissions stated that the warning should only be included on the oral gel.  Two submissions supported a warning on all topical miconazole containing products. One submission did not express an opinion.  One submission provided evidence regarding the low absorption of miconazole from creams and intravaginal formulations.  The extent of absorption was estimated at 1-2% in the studies provided.

Two warning statements were proposed.

Two submissions expressed an opinion on which statement was preferred.  In both cases the statement ‘Patients taking warfarin – talk to a healthcare professional before using [this product]’ was preferred.

The consultation asked whether the label statement database should be aligned with the Australian requirements for intravaginal miconazole products.

One submission expressed an opinion on this question. The statements were considered to be unnecessary as pharmacists are trained to provide this information to patients.  Also similar statements are not required for other intravaginal antifungal products.

Feedback was sought on a suitable target date for implementation.

Three responses were received.  One response stated as soon as possible, the other two responses suggested 18 months in line with similar labelling consultation outcomes.

After careful consideration of these responses Medsafe concludes that the label statements database should be updated to include the following advisory statement for miconazole oral gel:

Patients taking warfarin – talk to a healthcare professional before using [this product].

(Words of a similar meaning may be used).

Should further reports of an interaction between miconazole containing topical and intravaginal medicines and warfarin be reported to the Centre for Adverse Reactions Monitoring, Medsafe will revisit this issue.

Implementation

The label advisory statement for miconazole containing oral gel will be required to be placed on labels from 1 December 2018.  The Label Statements Database will be updated to this effect.

Enquiries

Any questions relating to this consultation should be directed via email to: medsafeapplications@health.govt.nz