Dutasteride Pregnancy and Breastfeeding Warnings

Dutasteride is also known as: Avodart

Dutasteride Pregnancy Warnings

Dutasteride 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 is considered contraindicated for use in women.

Dutasteride is absorbed through the skin. Therefore, women who are pregnant or may become pregnant should not handle the soft gelatin capsules because of the possibility of absorption of dutasteride and the potential risk of fetal anomaly to a male fetus. Studies in male animals have revealed evidence of decreases in fertility, reduced cauda epididymal sperm counts, microscopic changes in the male reproductive organs, reduced weights of the epididymis, prostate, and seminal vesicles. The effects of dutasteride on semen characteristics were evaluated in normal volunteers aged 18 to 52 throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up. At 52 weeks, the mean percent reduction from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in the placebo group. After 24 weeks of follow-up, the mean percent change in total sperm count in the dutasteride group remained 23% lower than baseline. While mean values for all semen parameters at all time points remained within the normal ranges and did not meet predefined criteria for a clinically significant change (30%), two subjects in the dutasteride group had decreases in sperm count of greater than 90% from baseline at 52 weeks, with partial recovery at the 24-week follow-up. The clinical significance of dutasteride's effect on semen characteristics for an individual patient's fertility is not known.

Dutasteride Breastfeeding Warnings

There are no data on the excretion of dutasteride into human milk.

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