Tuesday, May 15, 2012

FDA Safety Changes: New Adverse Events Added to Finasteride Label

In 1992, finasteride 5 mg was approved by the US Food and Drug Administration (FDA) for therapy of benign prostatic hyperplasia. In 1997, the FDA approved finasteride 1 mg for treatment of men with male-pattern hair loss. Off-label uses of finasteride 1 mg include reduction of facial hair in women and chemoprevention of prostate cancer.
Labels for finasteride 1 mg and finasteride 5 mg were revised in 2011 to note erectile dysfunction that persisted after drug discontinuation.

From Medscape Education Clinical Briefs > FDA Safety Changes for CME



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