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1 Combined Years 2-4 The adverse experience profiles in the 1-year, placebo-controlled, Phase III BPH studies and the 5- year open extensions with PROSCAR 5 mg and PLESS were similar. There is no evidence of increased adverse experiences with increased duration of treatment with PROSCAR 5 mg. New reports of drug-related sexual adverse experiences decreased with duration of therapy. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown. During a 4- to 6-year placebo- and comparator-controlled 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. In another 4-year, placebo-controlled study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men, but no cases were reported in men treated with PROSCAR. In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, 9060 had prostate needle biopsy data available for analysis. In the PROSCAR group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) men in the placebo group. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (stage T1 or T2). The clinical significance of these findings is unknown. This information from the literature (Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med 2003;349:213-22) is provided for consideration by physicians when PROSCAR is used as indicated. PROSCAR is not approved to reduce the risk of developing prostate cancer.
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REPORTS OF SUSPECTED PROPECIA SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Propecia. The information is not vetted and should not be considered as verified clinical evidence. Possible Propecia side effects / adverse reactions in 40 year old maleReported by a physician from Germany on 2011-10-03 Patient: 40 year old male weighing 86.0 kg (189.2 pounds) Reactions: Antiphospholipid Syndrome, Pulmonary Embolism Adverse event resulted in: hospitalization Suspect drug(s): Possible Propecia side effects / adverse reactions in 23 year old maleReported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-10 Patient: 23 year old male weighing 73.0 kg (160.6 pounds) Reactions: Breast Pain, Breast Mass Suspect drug(s): Possible Propecia side effects / adverse reactions in 36 year old maleReported by a health professional (non-physician/pharmacist) from France on 2011-10-13 Patient: 36 year old male Reactions: Testis Cancer, Gynaecomastia Adverse event resulted in: hospitalization Suspect drug(s):
Drug label data at the top of this Page last updated: 2008-02-15
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