The latest Drug Safety Update (Sept 2017) highlights that: despite repeated warnings, the MHRA continue to receive reports of harm or potential harm due to concomitant use of miconazole oral gel and warfarin.
OTC miconazole oral gel is no longer licensed for sale to people taking warfarin. The MHRA have provided the following advice for healthcare professionals:
- bleeding events, some with fatal outcome, have been reported with use of miconazole oral gel by patients on warfarin
- patients taking warfarin should not use over-the-counter miconazole oral gel available from pharmacies
- if the concomitant use of miconazole oral gel with an oral anticoagulant such as warfarin is planned, exercise caution and ensure that you monitor and titrate the anticoagulant effect carefully
- advise patients taking prescription-only miconazole oral gel and warfarin that if they experience signs of over-anticoagulation, such as sudden unexplained bruising, nosebleeds, or blood in urine, they should stop using miconazole and seek immediate medical attention