![]() Since the article was published in June 2016, we have received 25 Yellow Card reports, bringing the total possible drug interactions with miconazole and warfarin to 175. ![]() While further measures were being considered, an article in Drug Safety Update cautioned that miconazole oral gel is systemically absorbed and can enhance the anticoagulant effects of warfarin, potentially causing bleeding events. The Commission on Human Medicines was asked to advise on whether measures were needed to minimise risk to patients. In response to this report, the MHRA initiated a review of available data about this interaction. The coroner raised concerns about the risks for a drug interaction between miconazole oral gel and warfarin, and a possible lack of awareness of the interaction among healthcare professionals. In March 2016, the Medicines and Healthcare products Regulatory Agency (MHRA) received a Prevention of Future Deaths (regulation 28) report from a coroner regarding the death of a patient from intracerebral haemorrhage. Because of this, warnings are given in the Summaries of Product Characteristics about the potential for drug interactions between anticoagulants/warfarin and azole antifungals (of which miconazole is one) and the need for the anticoagulant effect to be carefully monitored. The potential for an interaction between miconazole and warfarin is documented in published literature, with articles describing case reports of interactions dating from the 1980s to 2016. The antifungal drug miconazole inhibits several P450 isozymes, including CYP2C9, which can heighten the anticoagulant effect of warfarin and lead to an increase in international normalised ratio (INR) values (and subsequent bleeding complications). 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 carefullyĪdvise 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 Patients taking warfarin should not use over-the-counter miconazole oral gel available from pharmacies Bleeding events, some with fatal outcome, have been reported with use of miconazole oral gel by patients on warfarin
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