Health
FDA panel reviews long-term risks of off-label testosterone use for menopause
ABC News reports that health specialists warned an FDA workshop about unresolved safety questions surrounding testosterone therapy in menopausal women.
The short version
- Specialists at an FDA public workshop expressed concerns regarding the long-term safety of off-label testosterone therapy for menopausal women.[ABC News]
- The FDA currently has no approved testosterone treatments specifically designated for menopausal women.[ABC News]
- Hormone replacement therapy prescriptions for women aged 50 to 65 grew by 72% between 2021 and 2025.[ABC News]
Key facts
- Specialists at an FDA public workshop cautioned that key questions regarding the long-term safety of testosterone therapy for menopausal women remain unanswered.[ABC News]
- According to the FDA's Center for Drug Evaluation and Research, there are no FDA-approved uses for testosterone therapy for menopausal women.[ABC News]
- Data from Epic Research indicates HRT prescriptions among women aged 50 to 65 increased 72% between 2021 and 2025.[ABC News]
What remains uncertain
- The long-term safety risks of off-label testosterone use in menopausal women remain unknown.[ABC News]
Sources
Outlet counts describe coverage, not independent confirmation. Reports may share a wire service or original source.
- FDA examines use of testosterone prescriptions for menopauseABC News - Top Stories