FDA examines testosterone therapy for menopausal women amid rising off-label use
US regulators hold public workshop to review evidence on benefits and risks as women increasingly turn to testosterone for menopause symptoms.
What to know
- The FDA convened a public workshop on testosterone therapy for menopausal women, an area with no approved female-specific products despite years of off-label use and growing demand.
- Specialists stressed that long-term safety data are lacking and concerns persist about cardiovascular and breast cancer risks, particularly for women with breast cancer history.
- While social media claims testosterone improves energy, muscle mass, and bone health, experts say evidence is strongest only for treating hypoactive sexual desire disorder (HSDD).
- An approved female-specific product could provide standardized dosing and safety monitoring; the UK, Australia, New Zealand, and South Africa have already approved testosterone products for women.
“The lack of a female-specific product creates practical challenges for clinicians, said Dr. Diana Tordoff, an instructor in obstetrics and gynecology at Stanford, noting that an approved product could provide standardized dosing, labeling and safety-monitoring guidance.”
Dr. Diana Tordoff, Instructor in obstetrics and gynecology, Stanford · Daily Maverick ↗
Dr. Stephanie Faubion Director, Mayo Clinic Center for Women's HealthDr. Diana Tordoff Instructor in obstetrics and gynecology, StanfordDr. Karen Adams Director, Stanford Medicine's Program in Menopause and Healthy AgingFDA US health regulator
How it unfolded 2 developments, newest first · click a bar or a number to jump articlesposts
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FDA public workshop on testosterone therapy convenes
The FDA held the public workshop on Thursday to examine testosterone therapy use in menopausal women. Specialists at the workshop cautioned that key questions about the therapy's long-term safety remain unanswered.
“We do not have any evidence in women that it will improve muscle mass or bone density or mood or well-being or really any other metric.”
— Dr. Stephanie Faubion -
first by The Hindu, 5d ago · also ABC News, Contemporary OB/GYN
2 more headlines
- FDA examines use of testosterone prescriptions for menopause ABC News · 5d ago
- FDA holding public meeting on testosterone use in menopausal women Contemporary OB/GYN · 4d ago
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FDA announces public workshop on testosterone therapy for menopausal women
The FDA announced it will hold a public meeting to review scientific evidence on testosterone use in menopausal women, including its benefits, risks, dosing, and role in female health. The meeting is intended to help guide future research and drug development as growing numbers of women turn to testosterone to manage menopause symptoms.
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2 outlets first by Daily Maverick, 6d ago · also Medscape · read ↗
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