Finasteride Pregnancy and Breastfeeding Warnings

Brand names: Propecia, Proscar

Finasteride Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned

Risk summary: Based on the mechanism of action and findings in animals, this drug may cause abnormal development of external genitalia in a male fetus when administered to a pregnant woman.

Comments:
-This drug is not indicated for use in females.
-Adequate methods of contraception should be encouraged.
-This drug is present in semen and therefore may pose a risk to the fetus. Male patients should be instructed to wear a condom during intercourse with women of childbearing potential or discontinue finasteride. This drug should be discontinued in patients wishing to conceive a child.
-Women who are or may become pregnant should not handle crushed or broken this drug tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of this drug and the subsequent potential risk to a male fetus. (This drug's tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.)

Animal studies have revealed evidence of teratogenicity and fetal harm. In an embryofetal development study in rats, a dose-dependent increase in hypospadias was observed in male offspring. Additional findings included decreased prostatic and seminal vesicular weights, delayed preputial separation, and transient nipple development along with decreased anogenital distance in male offspring at maternal oral doses approximately 0.03 times the maximum recommended human dose. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Finasteride Breastfeeding Warnings

Finasteride is not indicated for use in females.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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