Dutasteride / tamsulosin Pregnancy and Breastfeeding Warnings

Dutasteride / tamsulosin is also known as: Jalyn

Dutasteride / tamsulosin Pregnancy Warnings

Dutasteride-tamsulosin has been assigned to pregnancy category X by the FDA. Intravenous animal embryo-fetal development studies have revealed evidence of reduction in fetal adrenal weights, reduction in fetal prostate weights, increases in fetal ovarian and testis weights, feminization of male fetuses (decreased anogenital distance) and male offspring with nipple development, hypospadias, and distended preputial glands. Also reported were an increase in stillborns, reduced fetal body weight, increased incidences of skeletal variations considered to be delays in ossification associated with reduced body weight. Oral pre- and post natal animal development studies revealed evidence of feminization of the genitalia (decreased anogenital distance, increased incidence of hypospadias, and nipple development), prolonged gestation in the parental females, a decrease in time to vaginal patency for female offspring and decreased prostate and seminal vesicle weights in male offspring, effects on newborn startle response, increased stillbirths. There are no controlled data in human pregnancy. Preclinical data have suggested that the suppression of circulating levels of dihydrotestosterone (DHT) may inhibit the development of the external genital organs in a male fetus carried by a woman exposed to dutasteride. Feminization of male fetuses is and expected psychological consequence of inhibition of the conversion of testosterone to DHT. Dutasteride-tamsulosin is considered contraindicated for use in women.

Dutasteride / tamsulosin Breastfeeding Warnings

There are no data on the excretion of dutasteride or tamsulosin into human milk. Dutasteride-tamsulosin is contraindicated for use in women of childbearing potential, including nursing women.

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