• The FDA will eliminate black box warnings on hormone therapies for menopause.
• This decision aims to enhance the accessibility of treatment options for women.
• Experts support the overhaul, highlighting outdated fears associated with hormone therapy.
• New research suggests hormone therapy has beneficial effects when started early.
• Critics argue for cautious implementation to ensure patient safety.

The U.S. Food and Drug Administration (FDA) announced on November 10, 2025, that it will remove the stringent "black box" warnings from hormone therapies used to treat menopause symptoms, signaling a major shift in its health policy concerning women's health. According to FDA Commissioner Marty Makary, this change responds to evolving scientific evidence and aims to alleviate fears surrounding these essential treatments for women, which include relief from disruptive symptoms such as hot flashes and night sweats, among others, according to Reuters and Los Angeles Times.

The FDA's decision, supported by new data indicating that the dangers associated with hormone replacement therapy (HRT) may have been overstated, lifts warnings from over 20 hormone-based products, including pills, patches, and creams containing estrogen and progestin. Health Secretary Robert F. Kennedy Jr. emphasized the agency's commitment to evidence-based medicine, declaring that "we're challenging outdated thinking," according to Le Monde and NPR.

Critics have pointed out that past studies, particularly the Women’s Health Initiative conducted in the early 2000s, focused on older women whose health risks could skew the data. This criticism has paved the way for reevaluation of the black box warnings. Research now suggests that hormone therapy can improve health outcomes significantly when prescribed to patients younger than 60, or those within ten years of menopause onset, as emphasized by experts in the field, including Dr. JoAnn Pinkerton of the University of Virginia Health, according to Los Angeles Times and NPR.

Alongside the removal of warnings, the FDA also announced the approval of two new non-hormonal medications designed to treat severe hot flashes, further expanding options available to women experiencing menopausal symptoms. The first of these drugs, Lynkuet, targets neural activity to effectively diminish hot flashes, showcasing the FDA's commitment to providing effective solutions without the risks previously highlighted by former warning labels, according to Reuters and Le Monde.

Despite the positive shift, some experts call for a careful and transparent review process before implementing such significant changes. Diana Zuckerman, president of the National Center for Health Research, highlighted the ongoing need for thorough scrutiny of the benefits and risks. However, many healthcare professionals, including Dr. Steven Fleischman, the president of the American College of Obstetricians and Gynecologists, have expressed optimism about the FDA's revisions, suggesting that updated labels will facilitate a collaborative decision-making process between patients and practitioners, according to Los Angeles Times and NPR.