Ecco, allora ho trovato uno studio...
Direi che si può stare tranquilli. Se non si supera la dose di 5mg al giorno...
Citazione
regnancy—
Finasteride is not indicated for use in women {01} .
Because of the ability of 5-alpha-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone (DHT), finasteride administration to a pregnant woman may cause abnormalities of the external genitalia of a male fetus {01} .
Because of the potential risk to a male fetus, a woman who is pregnant or who may become pregnant should not handle crushed finasteride or broken {42} tablets {01} Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. {42}
Administration of finasteride to pregnant rats at doses ranging from 100 mcg per kg of body weight (mcg/kg) per day to 100 mg/kg per day (approximately 1 to 1000 times the recommended human dose of 5 mg and 5 to 5000 times the recommended human dose of 1 mg) produced dose-dependent development of hypospadias in 3.6 to 100% of male offspring {01} {41} . Pregnant rats given doses ³ 30 mcg/kg per day ( ³ three tenths of the recommended human dose of 5 mg and ³ 1.5 times the recommended human dose of 1 mg) produced male offspring with decreased prostatic and seminal vesicular weights, delayed preputial separation, and transient nipple development {01} {41} ; doses of ³ 3 mcg/kg per day ( ³ 3% of the recommended human dose of 5 mg and one fifth of the recommended human dose of 1 mg) produced decreased anogenital distance {01} {41} . All of these changes are expected pharmacologic effects of 5-alpha-reductase inhibitors and are similar to those reported in male infants with a genetic deficiency of 5-alpha-reductase {01} . The critical period during which these effects can be induced in male rats has been defined as days 16 to 17 of gestation {01} . No abnormalities were observed in female offspring exposed in utero to any dose of finasteride {01} .
In reproduction studies using male rats treated with finasteride doses of 80 mg/kg per day (61 times the human exposure of 5 mg and 488 times the human exposure of 1 mg) and untreated female rats, no developmental abnormalities were observed in first filial generation (F 1 ) male or female offspring {01} {41} . Administration of 3 mg/kg per day (30 times the recommended human dose of 5 mg and 150 times the recommended human dose of 1 mg) during the late gestation and lactation period resulted in slightly decreased fertility in F 1 male offspring; no effects were seen in female offspring {01} {41} . In rabbit fetuses exposed to finasteride in utero from days 6 to 18 of gestation at doses up to 100 mg/kg per day (1000 times the recommended human dose of 5 mg and 5000 times the recommended human dose of 1 mg), no evidence of malformations was observed {01} {41} ; however, effects on male genitalia would not be expected since the rabbits were not exposed during the critical period of urogenital system development {01} .
The in utero effects of finasteride exposure during the period of embryonic and fetal development were evaluated in rhesus monkeys (gestation days 20 to 100), a species more predictive of human development than rats or rabbits. Intravenous administration of finasteride to pregnant monkeys at doses as high as 800 ng/day (at least 60 to 120 times the highest estimated exposure of pregnant women to finasteride from semen of men taking 5 mg/day) resulted in no abnormalities in male fetuses. In confirmation of the relevance of the rhesus model for human fetal development, oral administration of a dose of finasteride (2 mg/kg/day; 20 times the recommended human dose of 5 mg/kg/day or approximately 1–2 million times the highest estimated exposure to finasteride from semen of men taking 5 mg/kg/day) to pregnant monkeys resulted in external genitalia abnormalities in male fetuses. No other abnormalities were observed in male fetuses and no finasteride-related abnormalities were observed in female fetuses at any dose. {42}
FDA Pregnancy Category X {01} .
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