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Steroid 5-α-reductase inhibitorsd
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Pregnancy category X: Dutasteride is contraindicated for use in women (GlaxoSmithKline, 2001). Finasteride is contraindicated in pregnancy or in women who may become pregnant (Medical Economics Co., 2003) and is classified as not intended for use by women (Medsafe, 2001). Possible adverse effect: low plasma level of DHT caused by exposure of women to dutasteride may inhibit fetal development of male external genitalia and internal reproductive organs (GlaxoSmithKline, 2001).
Animal studies
Rabbits, developmental studies – no developmental defects were observed in rabbit pups exposed to finasteride (up to 100 mg/kg/d) in utero (days 6–18 of gestation).
Monkeys, developmental studies – finasteride (0.8 μg/d, i.v.) was administered to pregnant rhesus monkeys (days 20–100 of gestation); no developmental abnormalities were observed in the male fetuses. In other studies, finasteride (2 mg/kg/d) administered orally to pregnant rhesus monkeys resulted in defects in the formation of the external genitalia of male fetuses; female fetuses were not affected.
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