REPLY
Hepatotoxicity Complicating Flutamide Treatment of Hirsutism
Diane K. Wysowski and
Jean L. Fourcroy
1 December 1993 | Volume 119 Issue 11 | Page 1150
IN RESPONSE:
In the United States, flutamide is approved by the Food and Drug Administration for use in combination with a luteinizing hormone-releasing hormone analog for the treatment of metastatic prostate cancer but not for benign prostatic hypertrophy, female hirsutism, or other hormonally mediated conditions.
The development of serious hepatotoxicity in a 20-year-old woman who was given flutamide for hirsutism, who had no other known causes of liver disorder, and who recovered after withdrawal of the drug provides confirmatory evidence that this drug can cause serious hepatotoxicity. In our case series [1], we reported that two 58-year-old men treated with flutamide for benign prostatic hypertrophy developed serious hepatotoxicity. Flutamide for treatment of female hirsutism was recommended based on a study of only 20 patients that showed it to be effective [2]. The size of the study, however, limited its potential to find any clinically significant or life-threatening side effects such as serious hepatotoxicity, given that the incidence of this disorder has been estimated to be less than 1% [3].
Physicians should exercise considerable caution in prescribing drugs for unapproved indications. They should inform patients treated with flutamide to immediately report any nausea, vomiting, fatigue, discolored urine, jaundice, and other signs and symptoms of liver injury so the drug can be promptly withdrawn.
The views contained in this letter are those of the authors and not necessarily those of the Food and Drug Administration.
1. Wysowski DK, Freiman JP, Tourtelot JB, Horton ML III. Fatal and nonfatal hepatotoxicity associated with flutamide. Ann Intern Med. 1993; 118:860-4.
2. Cusan L, Dupont A, Belanger A, Tremblay RR, Manhes G, Labrie F. Treatment of hirsutism with the pure antiandrogen flutamide. J Am Acad Dermatol. 1990; 23:462-9.
3. Gomez JL, Dupont A, Cusan L, Tremblay M, Suburu R, Lemay M, et al. Incidence of liver toxicity associated with the use of flutamide in prostate cancer patients. Am J Med. 1992; 92:465-70.
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