Medication Monitor

Generic Name (Trade Name—Company)
June 9, 2011

Finasteride, dutasteride

(Proscar, Avodart—Merck, GlaxoSmithKline, various generics for finasteride)
High-grade prostate cancer with 5-alpha reductase inhibitors

FDA is alerting health care providers that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor class of drugs has been revised to include new safety information about an increased risk of being diagnosed with a high-grade prostate cancer. Data from the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) showed an increased incidence of high-grade prostate cancer with use of finasteride 5 mg/d for 7 years and dutasteride 0.5 mg/d for 4 years.