As a Menopause Society Certified Practitioner (MSCP), I strongly support the recent FDA decision to remove the boxed warnings from FDA-approved estrogen therapies. For decades, these warnings created unnecessary fear and confusion for women and clinicians alike. They were based on early interpretations of the Women’s Health Initiative (WHI) that we now understand were overstated, misapplied, and widely misinterpreted.

The new FDA stance aligns with The Menopause Society guidelines and what experts in menopause care have been emphasizing for years: Menopausal hormone therapy (MHT) is the most effective treatment for vasomotor symptoms, and the benefits outweigh risks for the majority of healthy women under 60 or within 10 years of menopause.

Removing the boxed warning is an important step toward reducing stigma, improving access, and correcting misinformation. My hope is that this change empowers more clinicians to initiate conversations about hormone therapy rather than avoid them.

At Hoag, we launched our comprehensive Menopause Program because women deserve far better. We take an integrative, whole-person approach, grounded in evidence-based care and delivered by a multidisciplinary team, including gynecology, endocrinology, cardiology, mental health, pelvic health, and sexual medicine. Our goal is to individualize care by evaluating cardiovascular, breast, metabolic, and thrombotic risks, and to help each patient make an informed, personalized decision.

The removal of the boxed warning supports this individualized, evidence-guided approach, rather than the one-size-fits-all, fear-based messaging of the past. I know all too well that each time hormone therapy comes up in the news, questions and concerns follow. Some of the most frequently asked questions that I receive include the following.

What is menopausal hormone therapy?

Menopausal hormone therapy (MHT) refers to FDA-approved estrogen therapy, with or without a progestogen, used to treat symptoms of perimenopause and menopause and to provide prevention against osteoporosis. We now use the term MHT over hormone replacement therapy (HRT) when discussing symptom management for the natural menopausal transition, while HRT is used when hormones are replaced due to premature loss.

Estrogen can be delivered as a patch, pill, gel, spray, or vaginal therapy. Micronized progesterone, a type of progestogen, is often prescribed as an oral pill for patients with a uterus to protect the endometrium from unopposed estrogen. In line with national guidelines and leaders in the field, at Hoag we recommend FDA-approved formulations over compounded hormones, which lack standardization, FDA oversight, and long-term data.

Why is MHT prescribed?

Estrogen and progesterone are vital for much more than reproduction. Estrogen influences thermoregulation, sleep, mood, cognition, vaginal and vulvar health, pelvic floor support, bone formation, cholesterol metabolism, and overall metabolic health. When estrogen declines during the menopausal transition, these systems become vulnerable. MHT helps restore stability to these pathways and is the gold standard treatment for hot flashes, night sweats, sleep disruption, and genitourinary syndrome of menopause (GSM).

What is the link between MHT and bone health?

MHT is FDA-approved for the prevention of osteoporosis and significantly reduces fracture risk. This benefit is especially impactful for women who undergo early surgical menopause (removal of the ovaries before age 45), premature ovarian insufficiency, or have a strong family history of osteoporosis. MHT is one of the most effective interventions we have for preserving bone during midlife.

Does MHT affect dementia risk?

Current research suggests that timing matters. When initiated during perimenopause or early menopause, MHT may support brain energy metabolism and potentially reduce future dementia risk. This aligns with the “critical window hypothesis,” supported by neurological research and echoed by midlife health experts. However, starting MHT later in life does not appear to confer cognitive benefit, and may even be neutral or less helpful. Individual evaluation is key.

Are there risks to MHT?

Every treatment carries risk, including MHT. However, for healthy women under 60 or within 10 years of menopause, the absolute risks are rare and generally outweighed by the benefits. We carefully assess personal and family history of breast cancer, clotting risk, metabolic and cardiovascular health, symptom burden, and quality-of-life impact. For those who cannot or choose not to use hormone therapy, we also offer evidence-based non-hormonal options.

Why is the FDA announcement significant?

The FDA’s decision redirects attention to the actual health risks women face in midlife, including heart disease, bone loss, metabolic syndrome, and sexual health concerns, rather than perpetuating outdated fears about MHT. It also encourages meaningful conversations between patients and providers, fostering shared decision-making grounded in current science.

Final thoughts

Menopause is universal, but suffering is not. Modern menopause care should be empowering, not stigmatizing, and should reflect up-to-date evidence, not outdated fear. The FDA’s decision is a turning point, and I hope it encourages women to seek the care they deserve, and clinicians to provide it confidently.

Stephanie Da Silva Davis, MD, is an obstetrician-gynecologist.

Hoag is a nonprofit, regional health care delivery network in Orange County, California, that treats more than 30,000 inpatients and 480,000 outpatients annually. Hoag consists of two acute-care hospitals – Hoag Hospital Newport Beach, which opened in 1952, and Hoag Hospital Irvine, which opened in 2010 – in addition to nine health centers and 13 urgent care centers.