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Danazol, a derivative of the synthetic steroid ethisterone, was approved by the FDA in the 1970s for endometriosis and, more recently, for other chronic indications, including hereditary angioedema, ITP and fibrocystic disease of the breast.
Women can be assured that fibrocystic disease of the breast is a purely benign condition and there is no risk of developing malignancy.
Indicators of higher risk are: advanced age, breast cancer in mother, sister, or daughter, early onset of first period (under age 12), menopause after the age of 50, late first pregnancy or not having children, being white, a history of cancer of the uterus or in the other breast, fibrocystic disease of the breast, or having an abnormality in certain genes.