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Intravenous administration of finasteride to pregnant rhesus monkeys at doses as high as 800 ng/day during the entire period of embryonic and foetal development resulted in no abnormalities in male foetusesThis represents at least 750 times the highest estimated exposure of pregnant women to finasteride from semenIn confirmation of the relevance of the Rhesus model for human foetal developmentoral administration of finasteride 2 mg/kg/day100 times the recommended human dose or approximately 12 million times the highest estimated exposure to finasteride from semento pregnant monkeys resulted in external genital abnormalities in male foetusesNo other abnormalities were observed in male foetuses and no finasteride-related abnormalities were observed in female foetuses at any dose.

During the 7-year placebo-controlled Prostate Cancer Prevention TrialPCPTthat enrolled 18,882 menthere was 1 case of breast cancer in men treated with PROSCARand 1 case of breast cancer in men treated with placeboThe relationship between long-term use of finasteride and male breast neoplasia is currently unknown.

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In the clinical studies with PROPECIAthe incidences for breast tenderness and enlargementhypersensitivity reactionsand testicular pain in finasteride-treated patients were not different from those in patients treated with placebo.

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