For over two decades, the Food and Drug Administration (FDA) has issued warnings to women regarding the potential risks associated with using estrogen for treating menopause symptoms. Initial studies indicated a heightened risk of endometrial cancer, cardiovascular disorders, and breast cancer. However, these warnings are now being revised, thanks in part to FDA Commissioner Marty Makary, who has played a pivotal role in this decision. In this article, we explore the implications of this significant shift in FDA policy.
The black box warning on estrogen treatments has been in effect since 2003, following a 2002 study that caused widespread concern about hormone replacement therapy (HRT). The media coverage of this study created a climate of fear, leading to a significant decline in the number of women using HRT, which at one time was taken by up to 1 in 4 American women. According to Commissioner Makary, the initial findings of that study were ultimately misrepresented, as subsequent analyses did not show a statistically significant increased risk of breast cancer in the estrogen-only group. In fact, there was evidence suggesting a lower rate of breast cancer in that group.
Furthermore, Makary emphasizes that starting hormone replacement therapy within 10 years of the onset of menopause can yield profound cardiovascular benefits and help alleviate numerous symptoms associated with menopause.
When initiated around the time of menopause, hormone replacement therapy can help alleviate a variety of debilitating symptoms including hot flashes, night sweats, mood swings, and sleep difficulties. Contrary to the outdated belief that only a small percentage of women experience severe symptoms, current data indicates that over 80% of women face symptoms, with the average duration extending to eight years.
In addition to short-term symptom relief, the long-term benefits of hormone therapy are remarkable. Research published in the New England Journal of Medicine shows that hormone therapy can reduce the risk of bone fractures by 50-60% and decrease cognitive decline by up to 64%. Moreover, one study highlighted a 35% reduction in the risk of developing Alzheimer’s disease.
Women can access hormone replacement therapy in various forms, including pills, patches, creams, and gels. Previously, all these treatments carried a black box warning, but the FDA is now removing these warnings and opting for a more nuanced approach that presents the risks in package inserts. This decision aims to provide clearer information to women considering their options for menopause management.
Despite the benefits, it is essential to recognize that there are still risks associated with hormone replacement therapy. Initiating therapy more than 10 years after menopause onset can increase certain risks, such as cardiovascular issues. Makary explains that these risks arise because the body naturally produces estrogen, which is vital for maintaining healthy blood vessels. Starting hormone therapy too late can lead to narrowing of the blood vessels, increasing the likelihood of blood clots and heart disease.
While many women are suitable candidates for hormone replacement therapy, there are some contraindications. Women with a history of blood clots, active breast cancer, or certain other medical conditions should consult their healthcare provider before starting therapy. However, the majority of the approximately 2 million women entering menopause each year may benefit from hormone therapy, especially when combined with progesterone for those with a uterus to mitigate the risk of endometrial hyperplasia.
The process leading to the removal of the black box warning was expedited compared to typical FDA procedures. Commissioner Makary stated that the administration is committed to taking swift action on pressing health issues. This move follows a petition filed in 2016, which was initially overlooked but gained traction in 2025. The FDA convened a panel of diverse medical experts, bypassing the lengthy bureaucratic process to focus on presenting accurate information about the benefits and risks of hormone therapy.
The conversation surrounding menopause and hormone replacement therapy has evolved significantly in recent years. Many women have taken to social media to share their experiences and advocate for better understanding and access to hormone therapy. As awareness grows, it is crucial to balance the potential benefits of hormone therapy with an understanding of its risks, ensuring women make informed decisions about their health.
In conclusion, the FDA's decision to remove black box warnings on estrogen treatments represents a critical shift in recognizing the complexities of menopause management. As more women seek effective therapies to navigate this life stage, it is essential to provide them with comprehensive and accurate information.
