Dutasteride Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: X
US FDA pregnancy category: X
Comments:
-This drug may cause fetal harm as abnormalities in the genitalia of male fetuses are an expected consequence of this drug's inhibition of the conversion of testosterone to dihydrotestosterone (DHT).
-Condom use is recommended for male patients with female partners who are or may potentially be pregnant as it is not known whether a male fetus may be adversely affected if his mother is exposed to the semen of a patient being treated with this drug (the risk of which is greatest during the first 16 weeks of pregnancy).
-Patients should not donate blood until at least 6 months following their last dose to prevent pregnant women from receiving this drug through blood transfusion.
-The possibility of reduced male fertility cannot be excluded.
Animal studies have revealed adverse effects in male fetuses including inhibition of normal development of external genitalia and feminization of the genitalia. This drug is secreted into semen; however, the amount of this drug available for vaginal absorption may be reduced by how highly protein-bound (greater than 96%) this drug is in human semen. In a study with healthy men aged 18 to 52, reductions in sperm count, semen volume, and sperm motility were observed; however, sperm concentration and sperm morphology were unaffected.
AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.
US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
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