FDA Weighs Testosterone for Menopause

The U.S. Food and Drug Administration (FDA) will convene a public meeting on Thursday to scrutinize the scientific data concerning testosterone use in menopausal women. This review encompasses potential benefits, inherent risks, appropriate dosing, and its overall role in female health. The discussion is also expected to incorporate perspectives from both medical professionals and patients. This meeting is particularly significant as a growing number of women are exploring testosterone as a means to manage menopause symptoms. Currently, there is no FDA-approved testosterone therapy specifically for women, though it has been used off-label for years to address hypoactive sexual desire disorder (HSDD). Physicians often prescribe low doses of male-approved products or compounded formulations. The absence of a female-specific product presents challenges in standardized dosing and guidance. Some experts emphasize the need for more extensive long-term safety data. Countries such as the United Kingdom, Australia, New Zealand, and South Africa have already approved testosterone products tailored for women. The FDA's call for public comments revealed numerous submissions from women reporting enhanced libido, energy, and overall quality of life with testosterone use. Despite claims on social media about improvements in energy, muscle mass, bone health, and cognition, specialists note the strongest evidence supports its use for HSDD. Concerns about long-term safety, cardiovascular risks, and potential breast cancer risks have previously hindered FDA approval. Testosterone is generally not advised for women with a history of breast cancer due to its conversion to estrogen. Excessive exposure can lead to side effects like acne and increased hair growth, with some effects being irreversible.