The US Food and Drug Administration (FDA) has proposed removing the boxed warning on hormone replacement therapy (HRT), particularly local estrogen treatments, to make it easier for clinicians to recommend them. 

Speaking with El Médico Interactivo, a Medscape Network platform, ​Patricia María Menéndez de Luarca Bellido, MD, a gynecologist from Hospital General Universitario Gregorio Marañón, in Madrid​, Spain, said, “No regulatory change has been made, as the proposal is still under consultation.”

She added, “If this measure goes ahead, it will clearly make it easier to recommend HRT to patients. These treatments aim to improve quality of life, and while our guidance informs the decision, the final choice rests with the patient.”

On July 17, 2025, the FDA hosted the FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women. The panel focused on the risks and benefits of menopause hormone therapy, and in particular, the risk for breast cancer, uterine cancer, and certain cardiovascular risks vs potential benefits for bone, genitourinary, cardiovascular, and cognitive health.

The panel concluded that the risks associated with these therapies are lower than previously believed and recommended reviewing and updating outdated restrictions.

According to Menéndez, this initiative will encourage a detailed analysis of the scientific evidence supporting new therapeutic options that act selectively on target organs. “The FDA seems to be focusing on local estrogen treatment and may motivate the European Medicines Agency to take similar action,” she noted.

Primary Care Perspective

Gynecologists are familiar with these treatments and “understand the low risk relative to their benefit,” Menéndez said. In addition to relieving menopausal symptoms, HRT is used to treat such conditions as premature ovarian insufficiency.

Many women with menopausal symptoms first visit primary care physicians, who are often more cautious when prescribing drugs with these warnings. Menéndez explained that removing the warning might not drastically change prescribing patterns but could improve adherence, especially for local estrogen therapy, where systemic absorption is minimal.

Currently, product information for local therapies presents the same risks as systemic treatments, leading some women to discontinue therapy.

Clinical Indications

The demand for HRT is rising among women, whose symptoms affect their quality of life. Menéndez highlighted growing awareness of how hormonal changes during menopause affect bone health, cognitive function, and aging, noting that “some women request HRT for preventive reasons.”

A wide range of hormonal preparations and modified molecules is available, including selective estrogen receptor modulators that target specific organs more effectively. “We personalize prescriptions based on each patient’s symptoms. Options vary by dose; a sequential or a continuous regimen; and administration route, such as oral, transdermal, or vaginal, allowing women to select what works best for them,” Menéndez said.

This story was translated from El Medico Interactivo.