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Ketoconazole withdrawn by FDA, for almost all indications

July 30 2013

Ketoconazole, the world’s first oral azole antifungal, is being retired by the FDA. First launched by Janssen Pharmaceutica (Belgium) in 1985, it transformed the treatment of oral and oesophageal candidiasis and some endemic mycoses such as coccidioidomycosis. This week, the FDA restricted its use to the occasional patient with endemic mycoses, as a last resort.

The FDA cites “severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications”, as the reason for it shift in position. Early after launch, ketoconazole was extensively used for skin fungal infections, and was very effective for many and convenient. Unfortunately about 1 in 10,000-15,000 developed severe hepatic reactions, which were either fatal, or more recently required transplantation.  Adrenal dysfunction is also a significant issue.

The European Medicines Agency’s (EMA's) Committee on Medicinal Products for Human Use has also recommended that the marketing authorisations of oral ketoconazole-containing medicines should be suspended throughout the European Union (EU). The CHMP concluded that the risk of liver injury is greater than the benefits in treating fungal infections. (EMA report). The EMA recommends that patients currently taking oral ketoconazole for fungal infections should make a non-urgent appointment with their doctor to discuss suitable alternative treatments. 

Ketoconazole tablets are used throughout the world, as it is less expensive than other antifungals, but its use should be curtailed for all but the shortest courses. Fluconazole is a much safer alternative. Ketoconazole (Nizoral) shampoo carries no risk.


View the FDA report

EMA report