Can dutasteride be used in women?

Dutasteride Use in Women: Safety and Efficacy Considerations

Dutasteride is not recommended for use in women due to significant risks including feminization of male fetuses if used during pregnancy, with no FDA approval for female use. 1

Safety Concerns for Women

• Dutasteride is contraindicated in women who are or may become pregnant due to the risk of birth defects in male fetuses, specifically feminization of male genitalia 1
• The FDA drug label explicitly states that dutasteride is not indicated for use in women, with no information available on its presence in breast milk or effects on breastfed children 1
• Animal studies have shown that dutasteride exposure during pregnancy can cause:
  • Feminization of male fetuses 1
  • Fused skull bones 1
  • Increased placental weights 1
  • Reduction in fetal adrenal and prostate weights 1

Limited Evidence in Women

• There is very limited research on dutasteride use in women, with only a few small studies available 2
• One study evaluating dutasteride 0.15 mg daily for androgenetic alopecia in women showed increased hair thickness over 3 years, but this remains an off-label use 3
• Reported side effects in women include:
  • Decreased libido 2
  • Headache 2
  • Gastrointestinal discomfort 2
  • Isolated reports of menstrual changes, acne, and dizziness 2

Regulatory Status and Guidelines

• Clinical practice guidelines do not recommend dutasteride for women 4
• The American Society of Clinical Oncology guidelines for breast cancer risk reduction do not include dutasteride as a recommended agent, instead recommending tamoxifen, raloxifene, or exemestane for women at high risk 4
• Dutasteride is primarily indicated for benign prostatic hyperplasia in men, with its mechanism targeting male hormonal pathways 5

Special Considerations

• If considering off-label use in post-menopausal women (such as for female pattern hair loss), this should only be done after other FDA-approved treatments have failed 6
• Women of childbearing potential should not handle crushed or broken dutasteride capsules due to potential absorption and subsequent risk to male fetuses 1
• The long-term safety profile of dutasteride in women has not been established through large clinical trials 2

In conclusion, while limited data suggests potential efficacy for certain conditions like female pattern hair loss, the significant risks and lack of FDA approval make dutasteride generally inappropriate for use in women, particularly those of childbearing potential.