Proscar and Propecia have been FDA approved since 1992 and 1997 and are recorded with low adverse event profile.
Finasteride at 1mg and 5mg have similar effects on lowering PSA, prostate gland size, and serum DHT and T levels. 5mg was more effective in reducing symptoms of benign prostatic hyperplasia. The request for a product label change reflecting that Proscar was safe and effective for the reduction of prostate cancer was rejected because the reduction in low-grade prostate cancer was apparent, but the concern was the increased incidence of high-grade cancer.
5-alplha reductase inhibits (5 ARIs) have also been effective in treating prostatic hyperplasia and androgenetic alopecia (AGA). Since the approval of 5 ARIs millions of men have benefited from the treatment of AGA. As with the Proscar, the positive effects are apparent. The reduction in low-grade cancer diagnosis has increased, but the detection of high-grade cancer diagnosis has increased as well. Patients taking 5ARI should notify their physician or urologist in being evaluated because 5 ARI will lower their PSA value, which could lead to a misdiagnosis. All adverse events should be discussed during consultation and informed consent discussion. The Medicines and Healthcare products Regulatory Agency also suggested a breast cancer warning be present in product information due to an increase in male and female breast cancer in patients using Proscar and Propecia.
Placebo controlled double blind studies involving finasteride 5mg and 1 mg were reviewed. 8 cases were detected with 5 in the finasteride group and 3 in the placebo group. The incidence of reported male breast cancer in finasteride and dutasteride trials is higher than the general population, but the numbers are too small to support a cause and effect explanation.
Both finasteride and dutatsteride appear to reduce low grade prostate cancer while dutasteride may also be effective in prostate cancer precursors. Hair transplant physicians prescribing 5ARIs should include routine breast examinations and discussion of changes in breast tissues between patient and physician.
Mark A Bishara, M.D., P.A. Medical Director
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