Reactions to FDA's boxed warning removals for menopausal hormone therapy

Recently, 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. As Contemporary OB/GYN previously reported, all 3 products are estradiol transdermal patches from 2 applicants. The US Department of Health and Human Services announced the action on October 30, 2026, without naming the products or manufacturers.¹

The latest approvals extend the FDA’s February 12, 2026, labeling changes for 6 MHT products. Those changes covered 4 hormone therapy categories: progestogen alone, systemic estrogen alone, topical vaginal estrogen, and combined systemic estrogen and progestogen. The agency began working with companies on the changes in November 2025, and 29 drug companies have since submitted proposed labeling changes.^1,2

The FDA did not hold an advisory committee meeting before the October removals, according to a report from The Guardian. The agency also reiterated that it is not aware of an imminent risk of a nationwide estradiol patch shortage, noting that market output has doubled over the past 12 months as patients continue to report difficulty accessing patches.¹

Below, see multiple reactions to the removal of these menopausal hormone therapy boxed warnings.

Susan Reed, MD, MPH, MS

“I am glad to see the lifting of black box warnings on these transdermal estrogen products,” said Susan Reed, MD, MPH, MS, professor emeritus in the Department of Obstetrics and Gynecology at UW Medicine, in comments to Contemporary OB/GYN.

“The pendulum has swung from the far left to the far right. We need to carefully consider additional questions as the block box warnings continue to be lifted, finding the right balance for the safety of all women, particularly those with a uterus,” she said.

As more boxed warnings come off, Reed pointed to 2 questions she believes still need answers.

“Are these products safe when started over ages 60-65?” she asked. “Should there be a mention of risks when transdermal estrogens are taken with oral progestogens?”

Now that clinicians will counsel patients on treatments without a boxed warning, Reed emphasized open, clear communication.

“Careful shared decision-making is even more important than before,” she said. “Removal of the black box warnings makes it the clinician’s responsibility to understand risks for special populations based on the baseline cardiovascular and breast cancer risks, and based on their age.”

Calbeth C. Alaribe, DMSc, MPH, PA-C, CPCHE

“These changes offer an opportunity to reduce the stigma surrounding menopausal hormone therapy and make menopause a more comfortable topic in everyday conversations. Hormone therapy can provide meaningful relief from vasomotor symptoms, including hot flashes and night sweats. Fear surrounding earlier warnings may have discouraged some women from even discussing treatment with their clinicians,” said Calbeth C. Alaribe, DMSc, MPH, PA-C, CPCHE, ob-gyn hospitalist physician associate, published maternal health researcher, health equity strategist, speaker, women’s health advisor, and host of Contemporary OB/GYN’s Missed & Dismissed series.

“At the same time, I would want the public messaging to make clear that removing a boxed warning does not mean hormone therapy is appropriate for everyone. Benefits and risks depend on factors such as age, time since menopause, medical history, and the formulation and route of treatment. My concern is that the headline could overshadow the individualized conversations patients still need about cardiovascular risk, breast cancer risk, and contraindications,” she said.

“From a research and policy perspective, I would advocate for transparent, publicly accessible explanations of the evidence supporting these changes, including its limitations and where uncertainty remains. I would also like to see clear distinctions between evidence for different formulations, routes, and patient populations, alongside continued research that adequately represents historically underrepresented groups,” Alaribe added.

“As implementation expands, clinician education, understandable patient materials, and ongoing safety monitoring should accompany efforts to improve access. I hope that these changes help more women feel comfortable asking about treatment while strengthening informed, individualized decision-making,” she said.

References

1. Fitch J. FDA removes boxed warnings from 3 more menopausal hormone therapy products. Contemporary OB/GYN. Published October 30, 2026. Accessed November 2, 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 2, 2026. https://www.contemporaryobgyn.net/view/fda-updates-labels-on-multiple-menopausal-hormone-therapies