Review Date: 01/11/2025

Antifungal

Brand : Nizoral

Rationale 1

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has said that oral medicines containing ketoconazole ( known in the UK by the brand name Nizoral) should no longer be used for the treatment of fungal infections.

* The therapeutic indications have been restricted to patients resistant to, or intolerant of, other effective antifungal therapies

* The duration of treatment has been highlighted as a main factor in the risk of serious hepatotoxicity

* Several other drugs have been added to the list of contra-indications, including disopyramide, sertindole, nisoldipine, eplerenone, ergot alkaloids

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has said that oral medicines containing ketoconazole ( known in the UK by the brand name Nizoral) should no longer be used for the treatment of fungal infections.
The decision was made because some patients taking these medicines may be at an increased risk of liver damage and the risk outweighs the benefits. Alternative anti-fungal treatments are available.
The decision is only on oral products. Shampoos and creams containing ketoconazole are not affected by the decision.
July 2013
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* The special warnings and precautions about hepatotoxicity and monitoring of hepatic function before and after ketoconazole use have been amended
* New post-marketing adverse drug reactions have been added to the list of undesirable effects (anaphylactoid and anaphylactic reactions, angioneurotic oedema, adrenocortical insufficiency, cirrhosis)

The Drug Safety Bulletin makes the following recommendations for healthcare professionals:
* Ketoconazole tablets are not suitable as a first-line treatment or for superficial infections
* Ketoconazole tablets should be initiated by a physician who is experienced in the management of fungal infections
* Use only when potential benefits are considered to outweigh potential risks, taking into consideration the availability of other effective antifungal therapy
* Risk of serious hepatotoxicity increases with duration of treatment
* Liver function must be monitored before starting treatment, at week 2 and week 4 of treatment, and then monthly

MHRA Drug Safety Update (March 2008)