FDA to Probe Off-Label Testosterone Use in Menopausal Women on Sept. 17 as APRN Urges Training Scrutiny
Updated
Updated · The National Law Review · Sep 6
FDA to Probe Off-Label Testosterone Use in Menopausal Women on Sept. 17 as APRN Urges Training Scrutiny
1 articles · Updated · The National Law Review · Sep 6
Summary
Sept. 17 is the date for an FDA workshop on testosterone use in menopausal women, a growing off-label practice with no FDA-approved female testosterone products.
The agency says major knowledge gaps remain on sexual function, cognition, mood, musculoskeletal health, testosterone measurement, and long-term cardiovascular and breast cancer safety.
Maribel Dixon, a Tampa Bay family nurse practitioner, urged women to question providers about hormone-specific training, clinical background, monitoring plans, and why testosterone is being recommended.
Dixon said the issue is more urgent as menopause care evolves, noting the FDA in February 2026 removed certain boxed-warning language from six menopausal hormone therapy products after reviewing evidence.
The broader message, she said, is that menopause treatment should start with diagnosis and individualized evaluation rather than a single hormone level or routine prescribing.