FDA Holds Workshop on Testosterone for Menopausal Women as Prescriptions Jumped 146%
Updated
Updated · Fox News · Sep 19
FDA Holds Workshop on Testosterone for Menopausal Women as Prescriptions Jumped 146%
3 articles · Updated · Fox News · Sep 19
Summary
Thursday’s FDA workshop examined evidence, safety and research gaps for testosterone therapy in menopausal women, a treatment with no FDA-approved female product in the U.S.
Current guidelines support testosterone only for hypoactive sexual desire disorder, while evidence for energy, mood, bone health or sleep remains limited despite rising patient demand.
No approved female formulation leaves doctors using compounded creams or roughly one-tenth doses of male gel packets, creating dosing guesswork, prescription rejections and routine insurance denials.
One physician said a 10-month supply of discounted male gel cost less out of pocket than a single month of compounded cream, underscoring the access problems driving regulatory scrutiny.
The review follows growing patient and clinician pressure and comes after reports that testosterone prescriptions for women rose 146% from 2023 to 2026.