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FDA examines use of testosterone prescriptions for menopause

Read the original at ABC News (US) ↗
Cite

Tsapatsaris, A., & Howard, T. (2026, September 18). FDA examines use of testosterone prescriptions for menopause. ABC News (US). https://abcnews.com/Health/fda-examines-testosterone-prescriptions-menopause/story?id=136570571

Dated when The Aporia collected the article, usually within hours of publication. Check the original for its exact date and byline.

ABC News (US) · collected 2026-09-18 · by Ava Tsapatsaris, Tara Howard

Quick Summary

The FDA is investigating the off-label use of testosterone prescriptions for menopausal women, a practice growing despite lack of FDA approval due to unresolved long-term safety concerns. Specialists at an FDA workshop noted that while testosterone levels in premenopausal women naturally decline gradually and are linked to various health issues like bone density loss and mood changes, there is currently no definitive blood-test threshold to diagnose testosterone deficiency in women. With hormone replacement therapy prescriptions increasing by 72% from 2021 to 2025 for women aged 50-65, the FDA aims to gather more data to address women's health needs effectively.
Written by AI on 2026-09-19, from this article's own text only (the story summary below draws on all the coverage).

AI analysis

Story summary

FDA convened a public workshop to examine the rising off-label use of testosterone among menopausal women, amid concerns over its long-term safety. Clinicians are prescribing testosterone products designed for men at smaller doses due to a lack of FDA-approved formulations for women in the U.S. Studies show that while adult males have about 15 times more total testosterone than females, this hormone is still abundant in premenopausal women, produced at roughly three times the rate of estrogen. As women age and their testosterone levels decline, they may experience bone density loss, muscle mass reduction, cognitive decline, mood changes, sexual dysfunction, and decreased energy. Dr. Christina Chang from FDA's Center for Drug Evaluation and Research warned that there are no approved uses for testosterone therapy specifically for menopausal women in the U.S., highlighting the need for more research on its safety and efficacy.

Written for “Testosterone Use For Menopause Symptoms” on 2026-11-05, grounded in this article and the 1 other(s) covering the same event.

Story

📰 Testosterone Use For Menopause Symptoms
Health · 2 article(s) covering the same event. See how they differ ↓

Compared with similar articles

This article reads unscored and hedges 11% of its claims. Each row says how that neighbour differs.
Fox News
Hedges 3 of 23 claims Outlet record 68/100
The Straits Times
Hedges 3 of 38 claims Outlet record 66/100
“The articles discuss related topics but describe different events: one focuses on prescription delays and denials for testosterone therapy for menopause symptoms among patients and clinicians, while the other reports on an FDA public workshop examining long-term safety concerns of off-label testosterone use.”
How this article was measured signals, leaning charts, publisher record, byline, topics and claims

Signals How these are calculated →

Claims extracted
19
sentences that state something as happening or true
Uncertain
11%
2 of 19 hedged ("reportedly", "may", "according to")
Leaning
not political
takes no side on a contested political question
Publisher signals
67/100
ABC News (US)'s corrections and hedging, across everything collected from it. Not a measure of accuracy.
Outlets on this story
2
Health
Same framing elsewhere
1
articles that frame the event the way this one does
Analyzed 2026-09-19 · how these are computed

How this is being covered How these are calculated →

Article leaning vs. publisher reliability
Source leaning vs. consistency

Publisher

ABC News (US) · 1384 article(s) · 4 correction(s) detected
Running correction rate · 4 correction(s)

Who wrote this

Ava Tsapatsaris
1 article(s) here · 1 carrying a prediction
🔮 Because there is no FDA-approved testosterone formulation for women in the U.S., clinicians who prescribe the hormone may do so off-label and use smaller doses of testosterone products designed for men.
The only article under this byline in the corpus.
Tara Howard
1 article(s) here · 1 carrying a prediction
🔮 Because there is no FDA-approved testosterone formulation for women in the U.S., clinicians who prescribe the hormone may do so off-label and use smaller doses of testosterone products designed for men.
The only article under this byline in the corpus.

Topics

Center for Drug Evaluation and Research FDA Food and Drug Administration U.S. the University of Colorado School of Medicine

Subjects

FDA ORG · 8× ABC News ORG · 1× Center for Drug Evaluation and Research ORG · 1× Chang PERSON · 1× Christina Chang PERSON · 1× Epic Research ORG · 1× Food and Drug Administration ORG · 1× Margaret Wierman PERSON · 1× U.S. GPE · 1× the University of Colorado School of Medicine ORG · 1×

Narrative

There is rising off-label use of testosterone among menopausal women. Testosterone therapy is increasingly being used by menopausal women but specialists at a Food and Drug Administration (FDA) public workshop cautioned on Thursday that key questions about its long-term safety remain unanswered.
framing: assertive · carried by 1 article(s) · first seen 2026-09-19
🔮 Because there is no FDA-approved testosterone formulation for women in the U.S., clinicians who prescribe the hormone may do so off-label and use smaller doses of testosterone products designed for men.
2026-09-19 · ABC News (US)
FDA examines use of testosterone prescriptions for menopause · assertive framing

Claims (19 extracted, 2 hedged)

FDA examines use of testosterone prescriptions for menopause asserted
FDA → examine → menopause
There is rising off-label use of testosterone among menopausal women. Testosterone therapy is increasingly being used by menopausal women but specialists at a Food and Drug Administration (FDA) public workshop cautioned on Thursday that key questions about its long-term safety remain unanswered. asserted
questions → be → safety
Studies show that while adult males generally have 15 times more total testosterone than females, testosterone is the most abundant sex hormone in premenopausal women, produced at about three times the rate of estrogen. asserted
testosterone → show → estrogen
With age, women's testosterone levels gradually decline, and low levels have been linked to loss of bone density and muscle mass, along with declines in cognition, mood, sexual function and energy. asserted
levels → decline → cognition
Because there is no FDA-approved testosterone formulation for women in the U.S., clinicians who prescribe the hormone may do so off-label and use smaller doses of testosterone products designed for men. uncertain
who → be → men
"There are no FDA-approved uses for testosterone therapy for menopausal women," Dr. Christina Chang, division director of the division of urology, obstetrics and gynecology in the FDA's Center for Drug Evaluation and Research said at the FDA workshop Thursday. asserted
Chang → be → workshop
She noted that the agency is aware of increasing off-label use of testosterone among women experiencing menopause. asserted
agency → note → menopause
Currently, evidence supporting testosterone therapy in women is largely focused on hypoactive sexual desire disorder, a condition characterized by persistently low sexual desire that causes distress. asserted
that → support → distress
Specialists in the FDA workshop on Thursday said women are seeking testosterone for a much broader range of concerns including energy and mood. asserted
women → say → energy
Based on current guidelines, testosterone therapy is not considered a treatment for these symptoms. asserted
therapy → base → symptoms
Measuring testosterone in women also presents challenges because concentrations are much lower than in men. asserted
concentrations → measure → men
As such, there is no blood-test threshold that can diagnose whether a woman has a testosterone deficiency. asserted
woman → be → deficiency
Unlike estrogen, testosterone levels do not suddenly fall when women reach menopause. asserted
women → fall → menopause
"There is a gradual decline in testosterone levels across the premenopausal levels," Dr. Margaret Wierman, professor of medicine at the University of Colorado School of Medicine, told ABC News. asserted
Wierman → be → News
The growing interest in testosterone comes amid an increase in hormone replacement therapy (HRT) among menopausal women, which typically uses estrogen with or without progesterone to replace declining hormones during menopause. asserted
which → grow → menopause
HRT prescriptions among women ages 50 to 65 rose 72% from 2021 to 2025, according to data from Epic Research. uncertain
prescriptions → rise → Research
It comes after the FDA removed its "black box" warning label from HRT products for menopause earlier this year followed by the removal of the warning on testosterone products. asserted
FDA → come → products
"Menopause is inevitable, women should not have to suffer through it," Chang said. asserted
Chang → have → it
"To best serve the American women we need high-quality data and we are looking forward to working with all the manufacturers to be able to get that data." asserted
we → serve → data
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