FDA Expert Panel on Menopause and HRT Recommends Removing Black Box Labels

This episode presents an overview of an FDA hearing on menopause, prompted by a campaign addressing the "black box" warning on vaginal estrogen products. This warning, despite evidence suggesting its safety and localized effect, has deterred both doctors and patients from utilizing it, leading to significant health issues like recurrent UTIs. The discussion also challenged the lingering misinformation from the 2002 Women's Health Initiative study, which incorrectly linked hormone therapy to severe risks based on a study of an older demographic. Furthermore, the hearing highlighted the lack of FDA-approved testosterone for women, forcing off-label prescriptions, and underscored the importance of comprehensive education for healthcare providers and patients on menopause management. The speaker also noted the absence of discussion on progesterone and emphasized the need for a collaborative healthcare ecosystem involving researchers, regulatory bodies, payers, clinicians, and patients to improve women's health outcomes.