The Food and Drug Administration (FDA) announced on Monday (November 10) that hormone replacement therapies for menopause will no longer carry a black box warning. This decision comes after a thorough review of scientific evidence, indicating that previous warnings about risks such as breast cancer, heart attack, and stroke were based on outdated data. According to FDA Commissioner Marty Makary, the warnings discouraged many women from using hormone therapy despite its benefits.
Hormone therapies, which replace estrogen and progesterone, are commonly used to alleviate menopause symptoms like hot flashes, mood swings, and bone fractures. They are available in various forms, including pills, patches, and creams. The FDA's updated labeling will apply to products containing estrogen or progestogen, either alone or in combination. The agency emphasized the importance of starting hormone therapy in women younger than 60 or within 10 years of menopause onset to maximize benefits and minimize risks.
The decision to remove the black box warning follows the findings of a 2002 clinical trial that highlighted increased risks associated with a specific progesterone formulation not commonly used today. Recent studies have not found the same level of risk with current hormone therapy formulations. Many doctors believe the benefits of hormone therapy outweigh potential risks, and the removal of the warning could encourage more women to consider this treatment.
The FDA's decision was informed by an expert panel discussion in July 2025, which focused on the risks and benefits of menopause hormone therapy. The panel considered various factors, including age, formulation, and dosage, in evaluating the therapy's safety. The FDA also opened a public comment period to gather additional perspectives on hormone therapy use.
The removal of the warning label marks a significant shift in how hormone therapy is perceived and prescribed. The FDA hopes this change will help women access the benefits of hormone therapy without unnecessary fear. The agency also approved two new drugs for menopause symptoms, expanding treatment options for women.