FDA Grand Rounds: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context & Recent Changes

Why It Matters

The revised labeling directly influences prescribing patterns and patient counseling, impacting the health outcomes of millions of menopausal women and shaping the pharmaceutical market for hormone therapies.

Key Takeaways

• FDA updated MHT labeling with new boxed warnings after WHI findings.
• WHI trials linked hormone therapy to higher breast cancer, stroke, clot risks.
• Early 2000s saw a 30% drop in MHT prescriptions nationwide.
• Adding progestogen to estrogen therapy markedly reduces uterine cancer risk.
• Current FDA labels require clinicians to discuss VMS and GSM therapy risks.

Summary

The FDA Office of Women’s Health hosted a Grand Rounds session to review recent changes to menopausal hormone therapy (MHT) labeling, tracing the evolution from early 20th‑century products to today’s boxed warnings.

Speakers Dr. Nicholas Hazen and Dr. Aisha Johnson outlined how the 2002 Women’s Health Initiative (WHI) trials reshaped understanding of MHT. The large‑scale, double‑blind study of over 27,000 women revealed a 26 % relative increase in breast cancer and heightened risks of stroke, deep‑vein thrombosis, and pulmonary embolism, while showing modest protection against hip fracture and colorectal cancer.

The presenters highlighted that the WHI cohort averaged 63 years—far older than typical new users—explaining why early observational data had suggested cardiovascular benefits that the trial did not confirm. The FDA’s 2003 class‑wide labeling overhaul added a black‑box warning covering thromboembolic events, myocardial infarction, invasive breast cancer, and probable dementia, prompting an 18 % drop in prescriptions within three months and a 30 % decline by year’s end.

These regulatory updates force clinicians to individualize therapy, emphasizing non‑hormonal options for vasomotor symptoms when risks outweigh benefits. The shift also signals ongoing scrutiny of hormone products and underscores the need for continued post‑marketing surveillance and patient education.

Original Description

The FDA Office of Women's Health, in collaboration with the Center for Drug Evaluation and Research (CDER), presents this continuing education webinar on menopausal hormone therapy (MHT) labeling — what has changed, why it changed, and what it means for patients and providers.

In this presentation, FDA medical experts walk through the full history of menopausal hormone therapy regulation, the design and findings of the landmark Women's Health Initiative (WHI) trials, and the eight key recent changes to FDA-approved MHT prescribing information labels.

What You Will Learn:

The history of menopausal hormone therapy use and regulation, from the 1890s to today

The symptoms MHT is designed to treat, including vasomotor symptoms (VMS) and genitourinary syndrome of menopause (GSM)

The design, objectives, and findings of the Women's Health Initiative (WHI) trials

Why the WHI trials were stopped early and what the results meant for MHT use

How and why MHT use declined more than 70% following the 2002 WHI publication

The eight key recent changes to MHT prescribing information labels, including changes to boxed warnings for breast cancer, cardiovascular disease, dementia, and endometrial cancer

How age-of-use considerations are now reflected in updated MHT labels

What the updated labels mean for the four MHT drug classes: systemic estrogen plus progestogen (EP), systemic estrogen alone (E Alone), topical vaginal estrogen (E Alone Topical), and progestogen alone (P Alone)