FDA Proposes Changes to HRT Black Box Warning Amidst Rising Prescription Rates

Prescriptions for Hormone Replacement Therapy (HRT) for women have reportedly surged by approximately 72% since 2021, according to a recent social media post by Crémieux, despite existing black box warnings. This increase coincides with significant shifts in public perception and medical understanding of HRT, prompting the U.S. Food and Drug Administration (FDA) to propose substantial changes to the therapy's labeling.

The FDA announced on November 10, 2025, its request for labeling modifications to clarify the benefit/risk considerations for menopausal hormone therapies. These proposed changes include the removal of risk statements concerning cardiovascular diseases, breast cancer, and probable dementia from the Boxed Warnings, which the agency acknowledges may have contributed to the under-utilization of HRT among women who could benefit. An Expert Panel meeting in July 2025 preceded this decision, focusing on a comprehensive review of HRT's risks and benefits.

This development follows a period of heightened awareness and changing attitudes towards HRT. A study presented at The Menopause Society's 2025 Annual Meeting indicated that hormone therapy use among women aged 40 to 60 years in the U.S. rose from 8% in 2021 to 13% in 2025. Perceptions have also become more positive, with 49% of women aged 40-55 in 2025 believing the benefits outweigh the risks, a notable increase from 38% in 2021.

Globally, HRT prescribing has seen significant growth. Data from the NHS Business Services Authority in the UK revealed a 370% increase in HRT prescriptions over the past decade, with 14.7 million items dispensed in 2024/2025. Experts attribute this rise, in part, to increased social media attention and documentaries that have raised awareness about menopause and its management. Government initiatives, such as the UK's HRT Prescription Prepayment Certificate introduced in April 2023, have also made treatments more accessible and affordable.

The re-evaluation of HRT's safety profile marks a necessary update following earlier data from the Women’s Health Initiative (WHI) trials, which had significantly impacted public and clinical perceptions in the early 2000s. While the WHI findings were often communicated without full context, recent analyses have clarified that for younger individuals with symptoms, the benefits of hormone therapy often outweigh the risks. The FDA's proposed labeling changes aim to provide a more nuanced and accurate representation of HRT, potentially encouraging more informed discussions between patients and healthcare providers.