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Ketoconazole withdrawn by FDA, for almost all indications

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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.

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.

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