Dutasteride / tamsulosin Pregnancy and Breastfeeding Warnings

Brand names: Jalyn

Medically reviewed by Drugs.com. Last updated on Jun 3, 2024.

Dutasteride / tamsulosin Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: X
US FDA pregnancy category: X

Comments: If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies with dutasteride have revealed inhibited development of external genitalia in male fetuses and evidence of embryofetal lethality. Animal studies with tamsulosin have failed to reveal evidence of fetotoxicity. There are no controlled data in human pregnancy.

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.

See references