FDA Greenlights Labeling Changes for Menopause Hormone Therapies, Easing Safety Warnings

The U.S. Food and Drug Administration announced on Thursday that it has approved significant labeling updates for six menopausal hormone therapy drugs, marking a pivotal change in how safety information is presented to patients and healthcare providers. The move comes after a comprehensive review and aligns product warnings with current scientific evidence, potentially reshaping perceptions of hormone replacement therapy (HRT).

Under the newly approved labels, references to the risks of cardiovascular disease, breast cancer and probable dementia are being removed from the most prominent safety alerts — the “boxed warnings” — for these products. Previously, these warnings had been standard for decades, following earlier clinical studies linking hormone therapies with heightened health risks. The FDA’s decision reflects an updated assessment of the evidence and aims to provide more balanced information about risks and benefits.

The first group of therapies affected by the labeling changes includes a range of formulations used to relieve menopausal symptoms. These products span systemic estrogen-only and progestogen-only therapies, combination estrogen-progestogen treatments, as well as topical estrogen options. The updated labels cover drugs such as Prometrium, Divigel, Cenestin, Enjuvia, Bijuva and Estring, which are commonly prescribed to manage symptoms like hot flashes and vaginal discomfort.

The FDA’s updated labeling approach stems from an effort to better reflect modern scientific understanding of HRT’s safety profile. Historical data had driven widespread caution among both patients and doctors, contributing to a sharp decline in HRT use over the past two decades. By adjusting the way information is presented, regulators hope women and their clinicians can engage in more nuanced conversations about therapy options appropriate for individual needs.

Menopausal hormone therapies are used to mitigate a range of symptoms associated with menopause, a natural phase in a woman’s reproductive life. These symptoms can include vasomotor issues like hot flashes and night sweats, genitourinary changes such as vaginal dryness, and longer-term concerns like bone density loss. HRT can significantly improve quality of life for many women, especially when started within a certain timeframe after menopause onset.

Despite these potential benefits, utilization of HRT in the United States has lagged well behind the population of women who might benefit. Data from recent years shows a small fraction of women aged 45 to 64 received hormone therapy prescriptions, a trend linked in part to apprehension about safety concerns that arose from early clinical findings on cancer and cardiovascular risks.

The revised labeling is intended to help clinicians and patients navigate the benefit-risk balance with clearer, evidence-supported language. By removing outdated or overly cautious warnings, the FDA is signalling confidence that the updated safety profiles better reflect current knowledge, particularly for women who begin treatment closer to the onset of menopause.

Health officials emphasised that the changes do not eliminate all drug safety information. Instead, they aim to contextualise risks and benefits more accurately, ensuring that the boxed warning highlights only evidence-supported concerns. Other important safety considerations remain available in the prescribing information so that patients and doctors can assess therapy options comprehensively.

The FDA’s action follows its initiation of the review process late last year, when regulators first signaled plans to reassess how hormone therapy risks were communicated. The updated labels represent the first approved batch of changes, with additional products expected to undergo similar revisions as manufacturers submit proposals based on the new guidance.

Medical experts and women’s health advocates have generally welcomed the decision, noting that past “black box” warnings may have contributed to under-use of effective treatments. By aligning labeling with contemporary evidence, the FDA hopes to reduce barriers to care for women experiencing disruptive menopausal symptoms while maintaining transparency about known health risks.

As the updated labels take effect, clinicians will likely play a central role in guiding treatment decisions, tailoring discussions to patient histories and health goals. The FDA encourages individuals considering hormone therapy to consult with their healthcare providers to understand how the changes may influence their care.