FDA Updates Hormone Therapy Labels to Improve Menopause Care

In February 2026, the U.S. Food and Drug Administration (FDA) approved significant labeling changes for six menopausal hormone therapy products, also called hormone replacement therapy or HRT. This decision reflects a shift in how health authorities communicate the risks and benefits of hormone therapy for women experiencing menopause. The update removes previous boxed warnings regarding cardiovascular disease, breast cancer, and probable dementia, ensuring that women have access to accurate, science-based information when making health decisions.

Understanding Menopause and Its Challenges

Menopause is a natural biological stage that occurs when a woman's ovaries stop producing eggs and hormone levels, particularly estrogen and progesterone, decline. This transition generally occurs between the ages of 45 and 55. While menopause is a normal process, it often brings uncomfortable and sometimes debilitating symptoms.

Common menopausal symptoms include:

• Hot flashes and night sweats: These are known as vasomotor symptoms and affect up to 75% of women during menopause.
• Vaginal and urinary changes: Reduced estrogen levels can cause dryness, discomfort, and an increased risk of urinary tract infections.
• Osteoporosis: The loss of estrogen contributes to bone thinning, increasing fracture risk and long-term disability.
• Mood changes and sleep disturbances: Hormonal fluctuations may contribute to depression, anxiety, and insomnia.

These symptoms can significantly affect quality of life, making effective management essential for many women.

Hormone Replacement Therapy: Options and Benefits

Hormone replacement therapy is a medically recognized treatment for moderate-to-severe menopausal symptoms. The FDA has approved multiple forms of HRT to address specific needs:

1. Systemic combination therapy: This therapy combines estrogen and progestogen, such as the product Bijuva. It is commonly used for women with an intact uterus to reduce menopausal symptoms while protecting the uterine lining.
2. Systemic estrogen-alone therapy: Products like Divigel, Cenestin, and Enjuvia are indicated for women who have had a hysterectomy. Estrogen therapy helps relieve vasomotor symptoms and prevents bone loss.
3. Systemic progestogen therapy: For women using systemic estrogen who have a uterus, progestogen-alone therapy such as Prometrium helps reduce the risk of endometrial hyperplasia.
4. Topical vaginal estrogen therapy: Products like Estring provide targeted relief for vaginal dryness and urinary symptoms without significant systemic absorption.

Randomized clinical studies indicate that women who begin HRT within ten years of menopause onset, typically before age 60, may experience reductions in all-cause mortality and fracture risk. Despite these benefits, only a small percentage of eligible women use hormone therapy. In 2020, approximately 41 million women in the U.S. were ages 45 to 64, yet only around two million women ages 46 to 65 received an HRT prescription.

FDA Rationale for Labeling Updates

The FDA initiated the review of HRT boxed warnings in November 2025, following a comprehensive evaluation of the scientific literature. The agency worked with 29 drug manufacturers, requesting proposed labeling changes to better reflect current evidence. The updated labels remove previous statements suggesting elevated risk for heart disease, breast cancer, and dementia.

Health and Human Services Secretary Robert F. Kennedy, Jr. emphasized the importance of accurate information for women, stating that the decision ensures patients can make informed decisions without fear. FDA Commissioner Marty Makary highlighted the impact on women's health, noting that menopause can last for years, and women deserve clear, evidence-based guidance for their treatment options.

Risks and Considerations

Although HRT can be highly effective, it is not without potential risks. Women considering therapy should discuss their personal and family medical histories with a healthcare professional. Key considerations include:

• Cardiovascular health: Some older studies suggested an increased risk of heart disease, but newer evidence indicates that the risk is lower for women under 60 or within ten years of menopause onset.
• Breast cancer: Combination therapy may carry a slight increase in breast cancer risk, particularly with long-term use. Estrogen-only therapy in women without a uterus has not been associated with the same level of risk.
• Bone health: HRT has proven benefits in preventing osteoporosis and reducing fracture risk. Women at high risk for bone loss may find therapy particularly beneficial.
• Cognitive function: Concerns about dementia risk have not been confirmed in recent studies for women who start HRT near the onset of menopause.

It is important to note that treatment plans should be individualized. Dosage, route of administration, and duration of therapy all influence the balance of benefits and risks.

Benefits Beyond Symptom Relief

Hormone therapy offers advantages beyond managing hot flashes and vaginal discomfort. Some of the broader health benefits include:

1. Improved quality of life: Women report better sleep, mood stabilization, and increased energy.
2. Bone density preservation: Estrogen therapy helps maintain bone mass, lowering the risk of fractures and long-term disability.
3. Reduction in mortality risk: Evidence suggests that initiating HRT in the early years of menopause can lower all-cause mortality.

These benefits highlight why accurate, science-based information about HRT is critical for women making healthcare decisions.

Patient Empowerment Through Updated Labels

By removing outdated warnings, the FDA supports shared decision-making between patients and healthcare providers. Women can now consult the updated labels to better understand the potential benefits and risks of hormone therapy.

Patients are encouraged to:

• Review drug labels carefully and discuss concerns with their healthcare providers.
• Consider both systemic and localized hormone therapy options depending on symptoms.
• Evaluate personal and family medical history before initiating therapy.
• Understand that hormone therapy is generally more effective when started near the onset of menopause.

Updated labels are part of a broader effort to ensure medical information evolves alongside scientific evidence. They encourage women to take an active role in managing their health during menopause.

Addressing Common Myths About Hormone Therapy

Several misconceptions about HRT have contributed to underuse among women who could benefit. Updated labeling helps clarify these issues:

• HRT is only for severe symptoms: While therapy is often prescribed for moderate-to-severe symptoms, it can also prevent bone loss and support overall health.
• All women will experience severe side effects: Side effects vary, and many women tolerate therapy well, especially when individualized dosing is used.
• HRT significantly increases cancer risk: Modern studies show that the risk is nuanced and depends on therapy type, duration, and patient profile. Removing blanket warnings allows more accurate patient counseling.

By addressing these myths, healthcare providers can foster informed, confident decision-making.

Hormone Therapy in Modern Healthcare

The FDA’s labeling changes reflect broader trends in personalized medicine. Rather than relying on one-size-fits-all warnings, therapy recommendations are increasingly tailored to individual risk profiles. Clinicians can consider age, time since menopause, personal health history, and symptom severity when prescribing HRT.

Additionally, these updates align with patient-centered care principles. Women are encouraged to actively participate in decisions regarding their health, supported by transparent, evidence-based guidance.

Steps for Women Considering HRT

Women exploring hormone therapy should take the following steps:

1. Schedule a medical consultation: Discuss symptoms, treatment goals, and potential risks with a healthcare provider.
2. Review the drug label: Updated FDA-approved labels provide detailed information about benefits, side effects, and proper use.
3. Assess personal risk factors: Consider cardiovascular history, family history of breast cancer, bone health, and other medical conditions.
4. Discuss treatment options: Evaluate systemic versus topical therapy, combination versus estrogen-only therapy, and dosage forms.
5. Follow up regularly: Ongoing monitoring ensures that therapy remains safe and effective over time.

Women who understand the evidence and participate in shared decision-making are better positioned to benefit from hormone therapy while minimizing potential risks.

The Future of Menopause Care

The FDA’s labeling updates mark an important step toward evidence-driven menopause care. As research continues, healthcare professionals may refine treatment recommendations further, improving outcomes for millions of women.

Ongoing studies will focus on:

• Long-term safety of various hormone therapy formulations.
• Optimal timing for initiating therapy to maximize benefits and minimize risks.
• Personalized approaches based on genetics, lifestyle, and comorbidities.

As scientific knowledge evolves, updated labeling and education campaigns will play a crucial role in bridging the gap between research and patient care.

Conclusion

Menopause is a significant stage in a woman’s life, often accompanied by challenging symptoms and health considerations. Hormone therapy remains a valuable option for managing these symptoms and improving quality of life. With the FDA’s recent removal of outdated boxed warnings, women and healthcare providers now have more accurate, evidence-based information to guide therapy decisions.

Accurate labeling supports informed choices, empowers patients, and aligns clinical practice with modern scientific understanding. Women experiencing menopause symptoms should consult their healthcare provider to evaluate whether hormone therapy is appropriate for their individual needs.

By keeping abreast of the latest guidance, patients can make decisions that promote well-being, reduce the risk of complications, and enhance overall quality of life during menopause.

Sources:

• U.S. Food and Drug Administration (FDA). FDA Approves Labeling Changes to Six Menopausal Hormone Therapy Products. February 12, 2026.
• North American Menopause Society. Management of Menopausal Symptoms. 2025.

Disclaimer: This blog is intended for educational purposes only and does not constitute medical advice. Individuals should consult a licensed healthcare professional for personal diagnosis and treatment recommendations.