FDA to review evidence on testosterone therapy for menopausal women — Daily Maverick
In the United States, the Food and Drug Administration (FDA) will hold a public meeting on the use of testosterone by women during menopause. The regulator plans to review scientific data on the hormone’s potential benefits, risks, dosage and role in women’s health, Daily Maverick reports.
FDA has not approved testosterone for women
The FDA has not approved any testosterone therapy specifically intended for women. At the same time, doctors have for years prescribed such drugs off-label to treat hypoactive sexual desire disorder, a condition characterized by low sexual desire.
Doctors typically use low doses of products approved for men, including by dividing AbbVie’s AndroGel and Keenova Therapeutics’ Testim into smaller doses. Individually compounded medications are also used. Diana Tordoff, an instructor in obstetrics and gynecology at Stanford University, said that a specifically approved product for women could provide standardized dosing, labeling, safety monitoring recommendations and improved access to insurance coverage.
Lack of long-term data
Interest in testosterone among menopausal women has grown amid social media claims of possible improvements in energy, muscle mass, bone health and cognitive function. However, Stephanie Faubion, director of the Mayo Clinic’s Center for Women’s Health, stressed that the most convincing evidence concerns the treatment of hypoactive sexual desire disorder specifically.
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According to her, there is no evidence that testosterone improves muscle mass, bone density, mood or overall well-being in women. Karen Adams, director of Stanford’s Menopause and Healthy Aging Program, said the FDA has considered testosterone for use by women four times, but did not approve it because of a lack of long-term safety data and concerns about cardiovascular risks and breast cancer.
Excessive exposure to testosterone can cause acne and increased hair growth, while rarer effects, including voice deepening and hair loss, may be irreversible. Testosterone is generally not recommended for women with a history of breast cancer because it can be converted into estrogen in the body, which can stimulate certain types of cancer.
For certain patients with hypoactive sexual desire disorder, the FDA has approved non-testosterone treatment options Addyi and Vyleesi. At the same time, experts emphasize the need for additional long-term data on the safety of testosterone for women.
