U.S. regulators to examine testosterone therapy as use by menopausal women rises
The lack of a female-specific product creates practical challenges for clinicians, an approved product could provide standardised dosing, labeling and safety-monitoring guidance and potentially improve insurance coverage
The U.S. Food and Drug Administration (FDA) is set to review the scientific evidence on testosterone use in menopausal women, as the number of women turning to the hormone to manage menopause symptoms rises. The FDA's public meeting aims to guide future research and drug development, addressing the lack of an FDA-approved testosterone therapy for women despite years of off-label use.
Physicians often prescribe low doses of testosterone products approved for men or use compounded formulations, creating practical challenges for clinicians. The lack of a female-specific product raises concerns about standardised dosing, labeling, and safety-monitoring guidance. While some experts say more long-term safety data are needed, the United Kingdom, Australia, New Zealand, and South Africa have approved or licensed testosterone products specifically for women.
Brief written by urgent.news from The Hindu - Sci-Tech's own syndicated text. Machine-written — may contain errors; check the original before relying on it.
