Gynecomastia and Breast Cancer during Finasteride Therapy

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Abstract
From June 1992, when finasteride (Proscar) was approved for the treatment of prostatic hyperplasia, to February 1995, the Food and Drug Administration (FDA) received reports of gynecomastia in 214 men (ages, 47 to 90 years; median, 71) in the United States who were taking the drug. Gynecomastia has been the most frequently reported adverse effect of this drug, with an onset ranging from 14 days to 2 1/2 years (median, 180 days) after the initiation of therapy. Most of the men were taking the recommended daily dose of 5 mg. About 30 percent had unilateral gynecomastia, and 25 percent had bilateral involvement; the side or sides involved were not specified in 45 percent. Sixteen men (7 percent) had biopsies, 17 (8 percent) had mammography, and 12 (6 percent) underwent mastectomy. Fifty-eight (27 percent) were also taking other medications (such as digoxin, histamine H2 -receptor antagonists, spironolactone, lovastatin, and verapamil) known to be associated with gynecomastia.1 One hundred five men stopped taking finasteride. At the time of the report to the FDA, 69 of the 86 (80 percent) for whom information on the results after discontinuation was available had partial or complete remission of gynecomastia, and 17 (20 percent) had no change.

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