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Danocrine brand of Danazol capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011
WARNINGS and PRECAUTIONS
- include information regarding the risk of ovarian cancer in patients treated with Danocrine for endometriosis.
- Clinical studies of Danocrine did not include sufficient numbers of subjects aged 65 and over to determine the safety and effectiveness of Danocrine in elderly patients.
- regarding increased risk of myopathy and rhabdomyolysis with concomitant administration of danazol with statins.
- splenic peliosis