FDA Considers Easing Restrictions on Hormone Therapy for Menopause Symptoms

The U.S. Food and Drug Administration (FDA) is currently reviewing potential modifications to the warning labels associated with hormone replacement therapy (HRT) medications used to manage menopause symptoms. This development is considered a significant shift by many health professionals, who argue that the existing warnings have been overly cautious and may have contributed to under-treatment of menopausal discomfort.

FDA Commissioner Dr. Martin Makary indicated that discussions are underway regarding the removal or relaxation of the intense black box warning that has long been attached to estrogen-based therapies. This warning, the agency's most stringent for prescription drugs, highlights risks such as breast and uterine cancers, blood clots, strokes, and dementia in women over 65. Since its introduction in 2003, these warnings have led to a dramatic decline in hormone therapy prescriptions—down by more than 70%. Currently, only about 1 in 25 postmenopausal women use HRT, compared to 1 in 4 in the late 1990s.

The original warning stemmed from findings of the Women’s Health Initiative conducted in 2002, which linked estrogen use in older women to increased health risks. However, subsequent research suggests that these risks may not apply to younger women who begin therapy closer to menopause. Experts argue that the current strict warnings may have caused unnecessary fears, leading to women suffering from unmanaged symptoms such as hot flashes, night sweats, and sleep disturbances.

Many professionals, including Dr. JoAnn Manson from Harvard Medical School, believe that the existing warnings are more harmful than helpful, deterring women from using effective treatments. An FDA advisory panel comprising gynecologists and endocrinologists has also called for the removal of the warning, especially for formulations like low-dose creams, tablets, or rings that do not significantly enter the bloodstream.

While some experts acknowledge that not all hormone therapy products carry the same level of risk—as patches and creams might be safer for the heart—there remains a consensus that more research is necessary before endorsing widespread long-term use of HRT for preventing chronic diseases such as heart disease, Alzheimer’s, or osteoporosis.

Women are urged to consult their healthcare providers regarding hormone therapy and to approach claims and hype about its safety with caution. Accurate, individualized medical advice remains essential as the FDA reviews these warnings and considers potential changes.

For additional information, visit The Menopause Society’s resources on hormone therapy. All content is reviewed following strict editorial standards to ensure credibility and accuracy.

Source: https://medicalxpress.com/news/2025-10-fda-ease-hormone-therapy-menopause.html