(2003; 15 pages)
DANAZOL - Use restricted to second-line therapy in endometriosis
UK. The use of danazol (Danol) has been restricted to second- line therapy in endometriosis and benign fibrocystic breast disease, as a result of safety and risk-benefit assessments suggesting that it may increase the baseline risk of ovarian cancer in patients being treated for endometriosis. The following indications have been removed from the Danol Summary of Product Characteristics (SPC): gynaecomastia, pre-operative thinning of the endometrium prior to surgery, dysfunctional uterine bleeding presenting as menorrhagia to control excessive blood loss and to control dysmenorrhoea, control of benign, multiple or recurrent breast cysts in conjunction with aspiration.
News & Updates, UKMi, 10 Sept 2003.
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