Q&A: Soma Mandal, MD, MSCP, on FDA boxed warning removals for MHT

The FDA has approved updated labeling for 3 more menopausal hormone therapy (MHT) products, removing statements on cardiovascular disease, breast cancer, and probable dementia from their boxed warnings, Contemporary OB/GYN previously reported. All 3 are estradiol transdermal patches from 2 applicants. The US Department of Health and Human Services announced the action on October 30, 2026, without identifying the products or manufacturers.¹

The approvals extend the FDA’s February 12, 2026, labeling changes for 6 MHT products, which spanned progestogen alone, systemic estrogen alone, topical vaginal estrogen, and combined systemic estrogen and progestogen therapies. To date, 29 drug companies have submitted proposed labeling changes.^1,2

In initial reactions to the news, Susan Reed, MD, MPH, MS, said shared decision-making has become “even more important than before,” while Calbeth C. Alaribe, DMSc, MPH, PA-C, CPCHE, called for transparent, publicly accessible explanations of the evidence behind the changes.³

In a written interview with Contemporary OB/GYN, Soma Mandal, MD, MSCP, host of Contemporary OB/GYN’s Mind, Body, & The Pause series, shared her reaction to the changes, the questions she believes clinicians should bring to the FDA, and how the update affects her counseling.

“This is an important and overdue shift toward more accurate, individualized menopause care. For too long, broad boxed warnings made many women and clinicians understandably fearful of hormone therapy, even when the data did not apply to the specific patient or product being considered,” Mandal said.

“The original warnings were largely shaped by findings from the Women’s Health Initiative, which studied particular oral hormone formulations in an older population. Those findings should not be automatically generalized to every hormone therapy product, route of administration, dose, or patient. A transdermal estradiol patch is not the same as oral estrogen, and estrogen alone is not the same as estrogen combined with a progestogen,” she said.

“Removing outdated, class-wide risk language is not the same as saying hormone therapy is risk-free. It means we can finally have a more nuanced conversation that reflects what we now know: risks and benefits depend on a woman’s age, time since menopause, symptoms, medical history, dose, route of administration, and whether she has a uterus,” Mandal added.

Q&A with Soma Mandal, MD, MSCP

Contemporary OB/GYN: What questions should clinicians consider bringing to the FDA as a result of these changes, as no evidence was provided behind the changes?

Mandal: The FDA should be transparent about the evidence review and its product-specific rationale. Clinicians need clear guidance on exactly which risks are no longer appropriate for broad boxed-warning language, which risks remain relevant for certain patients, and how the labeling differs by route, formulation, and use of progestogens.

Important questions include:

• What evidence supported removing each specific risk statement for each affected product?
• How should clinicians communicate the remaining known risks, including venous thromboembolism, stroke, breast cancer, and endometrial cancer where applicable?
• How will the FDA ensure that updated labels clearly distinguish systemic therapy from low-dose local vaginal estrogen?
• Will the FDA provide practical, patient-centered tools to help clinicians discuss absolute risk rather than relying on alarming, one-size-fits-all language?
• How will the FDA monitor prescribing patterns and outcomes after these labeling changes, particularly among women who are older or further from menopause?

The goal should be clarity, not a pendulum swing from excessive caution to false reassurance (this is a concern).

Contemporary OB/GYN: What do clinicians know about these boxed warnings, and does this move change the way you would present these as a treatment option when talking with patients?

Mandal: Clinicians have long recognized that the boxed warnings were overly broad. They often did not reflect the differences among oral versus transdermal therapy, estrogen alone versus combined therapy, dose, or the timing of hormone initiation. We also know that starting systemic hormone therapy in a healthy woman under 60 years old or within 10 years of menopause is a very different clinical situation from starting it for the first time in an older woman many years beyond menopause.

This labeling change does not change my fundamental approach: menopause care must be individualized. I still review a patient’s personal and family history, cardiovascular and clotting risks, breast cancer history, uterine status, symptom burden, and treatment goals. I discuss benefits and risks in plain language, including what is known, what is uncertain, and how route and formulation may matter.

What does change is the tone of the conversation. Rather than beginning with a frightening boxed warning that can shut down discussion before it starts, we can focus on informed, shared decision-making. For many symptomatic women who are appropriate candidates, hormone therapy can be a safe and highly effective option. They deserve access to accurate information and care that is based on their individual health, not on outdated, blanket warnings.

References:

1. Fitch J. FDA removes boxed warnings from 3 more menopausal hormone therapy products. Contemporary OB/GYN. Published October 30, 2026. Accessed November 5, 2026. https://www.contemporaryobgyn.net/view/fda-removes-boxed-warnings-from-3-more-menopausal-hormone-therapy-products
2. Fitch J. FDA updates labels on multiple menopausal hormone therapies. Contemporary OB/GYN. Published February 12, 2026. Accessed November 5, 2026. https://www.contemporaryobgyn.net/view/fda-updates-labels-on-multiple-menopausal-hormone-therapies
3. Fitch J. Reactions to FDA’s boxed warning removals for menopausal hormone therapy. Contemporary OB/GYN. Published November 2, 2026. Accessed November 5, 2026. https://www.contemporaryobgyn.net/view/reactions-fda-boxed-warning-removals-menopausal-hormone-therapy