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The fetal effects of maternal finasteride exposure during the period of embryonic and fetal development were evaluated in the rhesus monkeygestation days 20-100in a species and development period more predictive of specific effects in humans than the studies in rats and rabbitsIntravenous administration of finasteride to pregnant monkeys at doses as high as 800 ng/dayestimated maximal blood concentration of 1.86 ng/mL or about 143 times the highest estimated exposure of pregnant women to finasteride from semen of men taking 5 mg/dayresulted in no abnormalities in male fetusesIn confirmation of the relevance of the rhesus model for human fetal developmentoral administration of a dose of finasteride2 mg/kg/day or approximately 18,000 times the highest estimated blood levels of finasteride from semen of men taking 5 mg/dayto pregnant monkeys resulted in external genital abnormalities in male fetusesNo other abnormalities were observed in male fetuses and no finasteride-related abnormalities were observed in female fetuses at any dose.

Frequency not reportedPruritusurticariaangioedema of the lipstonguethroatand faceRef]

During the 4to 6-year placeboand comparator-controlled MTOPS study that enrolled 3047 menthere were 4 cases of breast cancer in men treated with finasteride but no cases in men not treated with finasterideDuring the 4-yearplacebo-controlled PLESS study that enrolled 3040 menthere were 2 cases of breast cancer in placebo-treated men but no cases in men treated with finasterideDuring the 7year placebo-controlled Prostate Cancer Prevention TrialPCPTthat enrolled 18,882 menthere was 1 case of breast cancer in men treated with finasterideand 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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