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From the FDA Website:

“PRECAUTIONS

Increased Risk of High-Grade Prostate Cancer with 5-Alpha Reductase Inhibitors

• Men aged 55 and over with a normal digital rectal examination and PSA ≤3.0 ng/mL at baseline taking finasteride 5 mg/day (5 times the dose of Propecia) in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%). Similar results were observed in a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, Avodart) (1% dutasteride vs 0.5% placebo). 5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5α-reductase inhibitors to reduce to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.

ADVERSE REACTIONS

• During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with Proscar but no cases in men not treated with Proscar. During the 4-year placebo-controlled study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men but no cases in men treated with Proscar. During the 7-year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with Proscar, and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.”

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