Hepatotoxicity of Ketoconazole in Men and in Patients under 50

Edward Tabor, Food and Drug Administration
Anne Hume, University of Rhode Island
Larry Culpepper, Memorial Hospital of Rhode Island
Jack D. Sobel, Wayne State University


To the Editor: The article by Sobel (Dec. 4 issue)1 reports a possible new use for oral ketoconazole, but it is misleading about the patients who are potentially subject to hepatotoxicity from this use. The article incorrectly states, “The majority of patients in whom this complication has developed have been women over the age of 50.” The reference cited for this statement is the report by Lewis et al. of 33 cases of ketoconazole hepatotoxicity.2 However, the report by Lewis et al.2 included 13 patients under 50 (40 percent). They included a 5-year-old boy and a 17-year-old boy. The total…. © 1987, Massachusetts Medical Society. All rights reserved.