The Rise and Fall of Oral Ketoconazole.

Article Details

Citation
Copy to clipboard

Gupta AK, Lyons DC

The Rise and Fall of Oral Ketoconazole.

J Cutan Med Surg. 2015 Jul-Aug;19(4):352-7. doi: 10.1177/1203475415574970. Epub 2015 Mar 5.

PubMed ID
25775613 [ View in PubMed
]
Abstract

BACKGROUND: Ketoconazole was the first broad-spectrum oral antifungal agent available to treat systemic and superficial mycoses. Evidence of hepatotoxicity associated with its use emerged within the first few years of its approval. Growing evidence of serious side effects including endocrine dysregulation, several drug interactions, and death led to the review of oral ketoconazole in 2011. OBJECTIVE: This article chronicles the use of oral ketoconazole from its introduction to its near replacement in medicine. CONCLUSION: Due to its hepatotoxic side effects, oral ketoconazole was withdrawn from the European and Australian markets in 2013. The United States imposed strict relabeling requirements and restrictions for prescription, with Canada issuing a risk communication echoing these concerns. Today, oral ketoconazole is only indicated for endemic mycoses, where alternatives are not available or feasible. Meanwhile, topical ketoconazole is effective, safe, and widely prescribed for superficial mycoses, particularly as the first-line treatment for tinea versicolor.

DrugBank Data that Cites this Article

Drugs