European fears force TGA to review PBS drugs

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended oral ketoconazole-containing medicines be suspended after concluding the risk of liver injury was greater than the benefits in treating fungal infections.

In Australia, 200mg ketoconazole (Nizoral, Janssen) tablets are PBS listed for the treatment of systemic and deep mycoses where other available antifungal therapies have failed or are contraindicated, and for recalcitrant cases of superficial mycoses – due to susceptible fungi – which fail to respond to topical therapy and other conventional treatments.

The PI warns that “because of the risk for serious hepatotoxicity, Nizoral tablets should be used only when the potential benefits are considered to outweigh the potential risks, taking into consideration the availability of other effective antifungal therapy". 

A spokesperson for the TGA said available information on oral