Gynecomastia and Breast Cancer during Finasteride Therapy

Abstract

To the Editor: 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 . . .