This month the FDA moved to remove the long-standing boxed (“black box”) warnings from most menopausal hormone replacement therapy (HRT) products containing estrogen – a significant shift in how these medicines are labeled and discussed with patients. The change comes after years of advocacy from menopause experts and an FDA advisory panel in July 2025 that recommended eliminating warnings across all estrogen-based hormone replacement therapy (HRT) products. This is a meaningful and significant advance in the field of women’s health.
Some History
The boxed warning originated from early interpretations of the Women’s Health Initiative (WHI) trials (published in the early 2000s) which were widely read as showing major risks from HRT. Some of these risks included increased risk of cardiovascular disease, invasive breast cancer, and “probable dementia.” While the WHI trials were pivotal, there have been several limitations in the data, specifically the study design and interpretations of data that resulted in the widespread alarm. Namely, the study had an older patient population and was not representative of a typical menopause age patient (51 years old). It also tested only one formulation with conjugated equine estrogens and medroxyprogesterone acetate (MPA). These formulations are quite different from the “bioidentical” estradiol or micronized progesterone medications that are commonly used today. The estrogens were also only administered orally, as opposed to patches or gels which have a different risk profile. The WHI report also emphasized the relative risk of adverse effects without enough clarity or emphasis on the absolute risk, which was actually quite small.
The bottom line is that we have seen a whole generation of women who have not been able to benefit from estrogen-based hormone therapy to help mitigate the range of challenges menopause presents.
Important Changes for Menopause Care
HRT is FDA-approved for the relief of common menopausal symptoms including hot flashes, night sweats (vasomotor symptoms), changes to the vaginal, vulva, and urinary tract (genitourinary syndrome of menopause), and also bone “thinning” or decreased bone mineral density. While there are multiple other symptoms and changes that occur during menopause, the FDA has approved estrogen therapies for those listed above.
Multiple studies have shown that starting HRT within 10 years of menopause onset can have numerous benefits including reduced risk of all-cause mortality and fractures, association with 50% reduction in heart attack risk, and significant reduction in cognitive decline.
The removal of the black box warning encourages pharmaceutical companies to make changes to existing labels to provide accurate information about the benefits and risks of these drugs. This means changing language around the risks of cardiovascular disease, breast cancer, and probable dementia. The FDA is not seeking the removal of the boxed warning for endometrial cancer for systemic-estrogen alone products.
In addition to the removal of boxed warnings, the FDA is also approving two new drugs to expand treatment for menopausal symptoms. The FDA is approving a generic version of Premarin (conjugated estrogen), the first approval of its kind in 30 years. The second medication, Lynkuet (Elinzanetant) is a non-hormonal therapy for vasomotor symptoms or hot flashes that works by targeting neurokinin receptors in the brain to regulate body temperature.
Whether you are experiencing the beginning symptoms of perimenopause or are deep in your menopause experience, we’re here to help you feel your best through this transition. If you are a concierge patient of Dr. Taskier, all perimenopause and menopause services are included in the annual membership fee.