A Global Health Moment Few Expected

In November 2025, the U.S. Food and Drug Administration (FDA) removed a boxed warning from most systemic hormone therapy products used to treat menopausal symptoms. The change was enacted after years of research review, advisory inputs, public commentary, and opinion from the scientific community. Though debatable, the decision reflects an expanding body of evidence for a more nuanced approach to the understanding of hormone therapy risks.

The boxed warning issued in 2003 following the WHI study cited increased risks of cardiovascular events, stroke, breast cancer, and dementia, especially in older women in post-menopausal status. Being the primary force affecting practice and public opinion for more than 20 years, it did carry a considerable weight of influence.

Now, with the boxed warning removed for many oestrogen-containing products (including pills, patches, and creams), healthcare professionals and consumers alike are revisiting how these treatments are viewed.

Clarifying the Scope of the Change

The FDA’s action does not single out bioidentical hormone therapies, although products like Bijuva, which contain plant-derived hormones identical in structure to those made in the human body, are included. The change applies more broadly to over 20 approved systemic oestrogen and combination oestrogen-progestin therapies, including traditional products such as Premarin.

It is important to note that the FDA has retained the boxed warning for endometrial cancer in women who use oestrogen-alone therapy without a progestogen. That specific risk remains well-established.

A Process Rooted in Evidence Review

A contrary initial interpretation sees this label change as something that happened all alone. In July 2025, the FDA convened an expert panel and updated the review of the literature. This review included secondary analyses of the WHI data, which have led to the understanding of the “timing hypothesis”: hormone therapy carried a different risk profile when started closer to the onset of menopause than when initiated later, especially under age 60 or within 10 years of menopause.

Such biologic insights have changed the view of medical societies, including the North American Menopause Society and several of its European counterparts, regarding menopause treatment.

What the Data Say

The global hormone replacement therapy (HRT) market was valued at approximately $15.94 billion USD in 2023 and is projected to reach $27.52 billion USD by 2032. This growth reflects both rising demand and evolving product offerings. The market is expected to grow at a compound annual growth rate (CAGR) between 6.3% and 6.7% during the 2023–2028 period.

In the United Kingdom, NHS data indicates a steady increase in prescribed HRT items: from 10.9 million in 2022/2023 to 13 million in 2023/2024. The latest data show 14.7 million items dispensed in 2024/2025. This steady growth mirrors global interest in accessible, effective menopause care.

Online interest has also increased, with significant year-over-year growth in searches related to menopause and hormone treatment. While some sources suggest up to a 42% rise, precise global search trend figures remain difficult to verify.

Global Implications Beyond the U.S.

The FDA’s decision is unlikely to change regulatory practice overnight in regions like Canada, Australia, or the European Union. However, these agencies often observe U.S. precedent when re-evaluating drug safety data.

Current guidelines in many countries still emphasise individualised treatment, the lowest effective doses, and regular reassessment. These principles are informed by both earlier WHI findings and newer analyses that support the “timing” approach to hormone therapy.

As consumer awareness grows, international healthcare providers may experience increased patient enquiries about the risks and benefits of therapy previously marked by boxed warnings.

What This Means for You

For many women, especially those navigating the early years of menopause, this label change may invite a reconsideration of hormone therapy. But a removed warning is not a removal of risk.

Your age, medical history, symptom severity, and treatment goals still matter. Hormone therapy remains a powerful tool for managing hot flashes, sleep disruption, and bone loss—but it is not a one-size-fits-all solution.

Ask your healthcare provider whether your treatment options fall under the label changes. Clarify whether you are being prescribed systemic or local therapy, and what hormone types are included.

If you are already using HRT, consider scheduling a medication review to discuss any updates. If you are exploring treatment for the first time, request current patient information and enquire about the origin, approval status, and data behind the recommended product.

A Crowded Marketplace

The updated FDA label opens the door to more aggressive marketing and broader positioning for hormone therapies. As a consumer, you may encounter a wave of new or rebranded options promoted through telehealth platforms, online pharmacies, and wellness-focused brands.

Always verify that a treatment is approved by your country’s health authority. If data are cited, look for peer-reviewed sources or references to official guidelines. A growing number of HRT products include bioidentical hormones, but not all claims about their superiority are universally supported by regulators.

What This Means for Brands Producing These Drugs

Pharmaceutical companies and compound pharmacies are likely to view this regulatory update as an opportunity to expand market access. The absence of a boxed warning may shift how products are presented to physicians, patients, and payers.

The rise in adoption of hormonal products like Bijuva is an obvious consequence of healthcare professionals becoming more accepting of the regulatory stance. With such changes in perception, general hormone products stand to gain from the halo effect.

Yet, the responsibility to communicate risk should always lie with the marketers. Those brands willing to invest in provider education, release post-marketing data, and avoid overly aggressive claims might build more trust in a climate where messaging is heavily scrutinised.

Looking Ahead

The FDA’s boxed warning removal is not the final word on hormone therapy safety. It reflects a reassessment based on timing, population characteristics, and newer evidence. But it also leaves open many questions about long-term outcomes for diverse patient groups.

For now, the most reliable way forward for consumers is to engage in informed, individualised discussions with healthcare providers. As new data continue to emerge, so too will better guidance, but personal decisions should remain grounded in both current science and individual health priorities.