The risk of hepatic injury with oral ketoconazole is thought to be higher than that associated with other available antifungal treatments.
The MHRA has issued the following advice for healthcare professionals:
- Patients currently taking oral ketoconazole for fungal infections should be identified and reviewed at a routine appointment.
- Topical ketoconazole formulations (such as creams, ointments and shampoos) may continue to be used as systemic absorption of these preparations is minimal.
Previous licence restrictions
The updated advice follows a previous licence restriction, which limited the use of ketoconazole to infections resistant to other antifungals that could not be treated topically because of the site, extent of the lesion or depth of infection, and only where the potential benefits outweighed the potential risks of hepatotoxicity.