Oral ketoconazole prescribing suspended over hepatotoxicity risk

The antifungal ketoconazole (Nizoral) should no longer be prescribed as an oral treatment as the risks no longer outweigh the benefits, the MHRA has advised.

Oral ketoconazole (Nizoral) was used for resistant fungal infections, such as those caused by Candida albicans (pictured) | SCIENCE PHOTO LIBRARY
Oral ketoconazole (Nizoral) was used for resistant fungal infections, such as those caused by Candida albicans (pictured) | SCIENCE PHOTO LIBRARY

The risk of hepatic injury with oral ketoconazole is thought to be higher than that associated with other available antifungal treatments.

Action points

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.

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