SAFETY ALERT: 5-Alpha Reductase Labeling Update: Increased Risk of Prostate Cancer

The FDA has notified healthcare professionals that the Warnings and Precautions section of the labeling for the class of 5-alpha reductase inhibitors has been revised to include new safety information about the increased risk of being diagnosed with high-grade prostate cancer. The new safety information is based on the FDA's review of two large, randomized controlled trials––the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial––which evaluated daily use of finasteride 5mg versus placebo for 7 years and daily use of dutasteride 0.5mg versus placebo for 4 years, respectively, for the reduction in the risk of prostate cancer in men at ≥50 years of age. The trials demonstrated an overall reduction in prostate cancer diagnoses with finasteride and dutasteride treatment. This overall reduction was due to a decreased incidence of lower risk forms of prostate cancer. However, both trials showed an increased incidence of high-grade prostate cancer with finasteride and dutasteride treatment.

This risk appears to be low, but healthcare professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-alpha reductase inhibitors in men.

The class of 5-alpha reductase inhibitors includes Avodart (dutasteride; GlaxoSmithKline), Jalyn (dutasteride/tamsulosin; GlaxoSmithKline), Propecia (finasteride; Merck), and Proscar (finasteride; Merck).

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258529.htm.