FDA examines use of testosterone prescriptions for menopause
The FDA is investigating the rising off-label use of testosterone therapy among menopausal women, noting that long-term safety data is currently lacking. While some women seek the hormone for energy and mood, experts warn that there is no FDA-approved use for these symptoms.
Why it matters
The lack of clinical guidelines for testosterone use in women poses potential health risks as demand for the treatment grows.
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.
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.
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.
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.
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