As a Certified Practitioner of the Menopause Society (MSCP), I fully endorse the FDA’s recent decision to eliminate the boxed warnings from approved estrogen treatments. For many years, these warnings caused unwarranted anxiety among women and healthcare providers. They originated from initial readings of the Women’s Health Initiative (WHI) that have been deemed exaggerated and misread. The FDA’s updated position aligns with the guidelines from The Menopause Society and supports what menopause specialists have been advocating: Menopausal hormone therapy (MHT) is the most effective intervention for vasomotor symptoms, with advantages outweighing risks for the majority of healthy women under 60 or within a decade of menopause.

The elimination of the boxed warning is an essential measure in curbing stigma, improving access, and correcting misinformation. This move should empower healthcare providers to discuss hormone therapy openly. At Hoag, we have created a thorough Menopause Program that emphasizes integrative, evidence-informed, whole-person care. Our diverse team comprises specialists in gynecology, endocrinology, cardiology, mental health, pelvic health, and sexual medicine. We customize care by evaluating cardiovascular, breast, metabolic, and thrombotic risks, assisting each patient in making informed, tailored choices.

This FDA determination endorses a personalized, evidence-driven strategy that counters past fear-based narratives. I frequently receive inquiries whenever there is news about hormone therapy. Here are some of the most prevalent questions:

**What is menopausal hormone therapy?**
MHT encompasses FDA-approved estrogen treatment, with or without a progestogen, to alleviate perimenopause and menopause symptoms and avert osteoporosis. MHT is favored over hormone replacement therapy (HRT) for managing symptoms associated with the natural menopausal transition, while HRT is applied for hormone replacement due to premature loss. Estrogen can be administered as a patch, pill, gel, spray, or vaginal treatment. Micronized progesterone is commonly prescribed orally to safeguard the endometrium from unopposed estrogen, with FDA-approved formulations preferred over compounded hormones due to issues with standardization and quality control.

**Why is MHT prescribed?**
Estrogen and progesterone have essential functions beyond reproduction, affecting thermoregulation, sleep, mood, cognition, vaginal wellness, bone formation, cholesterol management, and metabolic health. As estrogen levels drop during menopause, these systems are impacted. MHT restores equilibrium and is the gold standard for treating hot flashes, night sweats, sleep disturbances, and genitourinary syndrome of menopause (GSM).

**What is the correlation between MHT and bone health?**
MHT is FDA-approved for osteoporosis prevention and significantly lowers the risk of fractures, particularly for women undergoing early surgical menopause, premature ovarian insufficiency, or those with a strong family history of osteoporosis. MHT is among the most effective strategies for bone preservation in midlife.

**Does MHT influence dementia risk?**
Studies indicate that timing is crucial. Initiating MHT during perimenopause or early menopause may help lower dementia risk and enhance brain energy metabolism, in accordance with the “critical window hypothesis.” However, starting MHT later usually provides no cognitive advantages. Individual evaluation is vital.

**Are there risks associated with MHT?**
MHT, like any intervention, carries certain risks. Nevertheless, for healthy women under 60 or within a decade after menopause, the benefits generally surpass the rare absolute risks. We examine individual risks related to breast cancer, clotting, metabolic and cardiovascular health, symptoms, and quality of life. Non-hormonal alternatives are also available.

**Why is the FDA announcement important?**
The FDA’s ruling shifts attention to genuine midlife health concerns, such as heart disease and metabolic syndrome, rather than outdated MHT fears. It fosters constructive patient-provider discussions, promoting shared, science-informed decision-making.

In summary, menopause is a universal occurrence, but suffering from it should not be. Contemporary menopause care should empower individuals rather than stigmatize them and reflect current evidence. The FDA’s decision represents a significant shift, encouraging women to pursue the care they need and professionals to provide it with assurance.