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HealthQuiet 5d · day 7

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

FDA examines testosterone therapy for menopausal women amid rising off-label use
abcnews.com

How it unfolded 2 developments, newest first · click a bar or a number to jump articlesposts

Peak 2 pieces in two hours at Sep 17, 5 AM; 7 pieces over 7 days (6 articles · 1 post) Sep 17, 5 AM — 2 pieces · 2 articles — Google News 1, Newswires 1Sep 17, 7 AM — 1 piece · 1 article — Newswires 1Sep 17, 9 AM — quietSep 17, 11 AM — quietSep 17, 1 PM — quietSep 17, 3 PM — quietSep 17, 5 PM — quietSep 17, 7 PM — quietSep 17, 9 PM — quietSep 17, 11 PM — quietSep 18, 1 AM — quietSep 18, 3 AM — quietSep 18, 5 AM — quietSep 18, 7 AM — quietSep 18, 9 AM — quietSep 18, 11 AM — 1 piece · 1 article — Newswires 1Sep 18, 1 PM — quietSep 18, 3 PM — quietSep 18, 5 PM — 2 pieces · 1 article · 1 post — Mastodon 1, Newswires 1Sep 18, 7 PM — quietSep 18, 9 PM — quietSep 18, 11 PM — quietSep 19, 1 AM — quietSep 19, 3 AM — quietSep 19, 5 AM — quietSep 19, 7 AM — 1 piece · 1 article — Google News 1Sep 19, 9 AM — quietSep 19, 11 AM — quietSep 19, 1 PM — quietSep 19, 3 PM — quietSep 19, 5 PM — quietSep 19, 7 PM — quietSep 19, 9 PM — quietSep 19, 11 PM — quietSep 20, 1 AM — quietSep 20, 3 AM — quietSep 20, 5 AM — quietSep 20, 7 AM — quietSep 20, 9 AM — quietSep 20, 11 AM — quietSep 20, 1 PM — quietSep 20, 3 PM — quietSep 20, 5 PM — quietSep 20, 7 PM — quietSep 20, 9 PM — quietSep 20, 11 PM — quietSep 21, 1 AM — quietSep 21, 3 AM — quietSep 21, 5 AM — quietSep 21, 7 AM — quietSep 21, 9 AM — quietSep 21, 11 AM — quietSep 21, 1 PM — quietSep 21, 3 PM — quietSep 21, 5 PM — quietSep 21, 7 PM — quietSep 21, 9 PM — quietSep 21, 11 PM — quietSep 22, 1 AM — quietSep 22, 3 AM — quietSep 22, 5 AM — quietSep 22, 7 AM — quietSep 22, 9 AM — quietSep 22, 11 AM — quietSep 22, 1 PM — quietSep 22, 3 PM — quietSep 22, 5 PM — quietSep 22, 7 PM — quietSep 22, 9 PM — quietSep 22, 11 PM — quietYesterday, 1 AM — quietYesterday, 3 AM — quietYesterday, 5 AM — quietYesterday, 7 AM — quietYesterday, 9 AM — quietYesterday, 11 AM — quietYesterday, 1 PM — quietYesterday, 3 PM — quietYesterday, 5 PM — quietYesterday, 7 PM — quietYesterday, 9 PM — quietYesterday, 11 PM — quietToday, 1 AM — quiet 12
Sep 18Sep 19Sep 20Sep 21Sep 22yesterdaynow · 3:50 AM ET
  1. 2

    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
    1. first by The Hindu, 5d ago · also ABC News, Contemporary OB/GYN

      2 more headlines
  2. 1

    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.

    1. 2 outlets first by Daily Maverick, 6d ago · also Medscape · read ↗