Q&A: Kanchi Chadha, MD, FACOG, MSCP, on FDA boxed warning removals

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 a written interview with Contemporary OB/GYN, Kanchi Chadha, MD, FACOG, MSCP, an ob-gyn and director of the Midlife Women’s Health and Longevity Program at Hackensack University Medical Center, shared her reaction to the changes, the questions she believes clinicians should bring to the FDA, and whether the update changes how she counsels patients.

“As an obstetrician-gynecologist and a women’s health advocate who cares for many women through the menopausal transition, I support reconsidering the boxed warnings, which have long overstated risk for the typical symptomatic woman under 60. However, the press release cites ‘a thorough re-examination of the scientific literature’ without citing a single study or any evidence behind the change. Without the data, clinicians have little reason to feel confident about changing how they manage patients,” Chadha said.

Q&A with Kanchi Chadha, MD, FACOG, MSCP

Contemporary OB/GYN: What questions should clinicians consider bringing to the FDA as a result of these changes?

Chadha:

• Which research studies support removing black-box warnings on cardiovascular disease, breast cancer, and dementia risk from menopausal hormone therapy patches?
• Are the changes specific only to estradiol patches?
• What kind of post-marketing surveillance plan is being put in place, and what outcomes would trigger relabeling?
• What is the plan for addressing or resolving the current shortage of estradiol patches, especially as demand is expected to increase with the removal of these black-box warnings?

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?

Chadha: The boxed warnings originate from the 2002 WHI estrogen-progestin trial, which showed increased breast cancer, CHD, stroke, and VTE rates, and to WHIMS, which showed increased dementia in women 65 and older. Later analyses found the absolute risks in women starting under 60 are low, and estrogen-alone therapy did not increase breast cancer risk.

I think this recent move will not change my core counseling, as I will still look for each patient’s candidacy, recommend the best route and regimen, and reassess annually. I will continue to have an honest discussion about the increased breast cancer risk associated with duration of use and with combined therapy, even though the absolute risk is small.

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. 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