Yes, Finasteride is FDA-Approved and Guideline-Recommended for Male Pattern Baldness
Finasteride 1 mg daily is an established, FDA-approved treatment for androgenetic alopecia (male pattern hair loss) in men, with strong guideline support and robust long-term efficacy data. 1
FDA Approval and Mechanism
- Finasteride is a competitive and specific inhibitor of Type II 5α-reductase, which blocks the conversion of testosterone to dihydrotestosterone (DHT) in the scalp, liver, and skin. 1
- The drug was originally approved for benign prostatic hyperplasia in 1992, with approval expanded in 1997 to include treatment of male pattern hair loss at the 1 mg daily dose. 2
- DHT induces androgenic effects by binding to androgen receptors and is implicated in the androgen-dependent miniaturization of scalp hair follicles that causes male pattern baldness. 1, 3
Guideline Recommendations
- The American Academy of Dermatology recommends initiating finasteride 1 mg daily for men aged 18-60 years with male pattern hair loss seeking medical treatment. 4
- Patients should be counseled that visible improvement typically begins by 12 weeks, with maximal benefit at 1-2 years, and that efficacy is maintained over 5+ years but hair loss resumes if treatment is discontinued. 4
- The American College of Physicians also recommends finasteride 1 mg daily for treating male pattern hair loss. 4
Efficacy Data
- Treatment with finasteride 1 mg daily leads to clinically significant increases in hair count measured in a 1-inch diameter circular area of balding vertex scalp (107 and 138 hairs versus placebo at 1 and 2 years, respectively). 3
- Long-term treatment over five years leads to durable improvements in scalp hair growth and slows the progression of hair loss that occurs without treatment. 5
- Patients' self-assessments demonstrate that finasteride treatment slows hair loss, increases hair growth, and improves appearance of hair, corroborated by investigator assessments and photographic review. 3
Sexual Side Effects Profile
- Sexual adverse events, including decreased libido, ejaculation disorders, and erectile dysfunction, occur in approximately 2-4% more patients compared to placebo. 4
- These side effects are uncommon after the first year of therapy and are reversible upon discontinuation. 4
- The magnitude of sexual dysfunction effect is relatively small, with a mean difference of 3.21 points on sexual function scales compared to 1.26 points for each year of aging. 4
- New reports of drug-related sexual adverse experiences decrease with duration of therapy. 1
Critical Considerations for Men Taking Finasteride
- Finasteride 1 mg reduces PSA levels by approximately 50% after 12 months of therapy, which must be considered when interpreting prostate cancer screening results. 4
- Men taking finasteride 1 mg must have their PSA values doubled after 12 months of therapy when screening for prostate cancer. 4
- Consider obtaining a PSA baseline before starting treatment in men approaching prostate cancer screening age (>40-45 years). 4