EMA suspends use of oral ketoconazole because of liver injury risk

The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) has recommended that the marketing authorizations of oral ketoconazole-containing medicines should be suspended throughout the European Union. The CHMP concluded that the risk of liver injury is greater than the benefits in treating fungal infections.

The EU-wide review of oral ketoconazole was triggered by the suspension of the medicine in France. The French medicine agency, the National Agency for the Safety of Medicine and Health Products (ANSM), concluded that the benefit-risk balance of oral ketoconazole was negative because of a high level of liver injury associated with the medicine and in view of the currently available alternative treatments, which are deemed to be safer.