I witnessed history on Monday as the FDA and HHS announced that the black box warning would be removed from hormonal products for menopause. This is the first time in over 20 years when an announcement of this scale has been made about menopause and women’s health.
Menopause is not just a transition that causes hot flashes and bodily symptoms such as heart palpitations. It can cause cognitive symptoms like brain fog, forgetfulness and mental health symptoms such as low mood and anxiety, leading some women to leave the workplace in midlife.
Medications have long been available to alleviate many of these symptoms, but due to flawed research from decades ago, menopausal hormonal treatments have carried a stigma, creating confusion and anxiety in women about whether they should take them.
As a menopause and mental health expert, I was one of several physician experts asked to be present at a press conference held by U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary, M.D., M.P.H., announcing their plan to remove the long-standing black box warning on hormonal therapy for menopause treatments. This could be a game changer for keeping women in the workplace.
Menopause symptoms such has brain fog, memory issues, feeling disorganized, forgetting a word that is on the tip-of-the-tongue and general forgetfulness are symptoms that impact productivity and confidence in the workplace for millions of women. Some studies suggest that these symptoms and others due to menopause may lead women to experience lower productivity in the workplace and some of those women leave the workplace in midlife due to these symptoms. Those studies showed that approximately 10% of the women surveyed left the workplace and 23% considered leaving. The loss of productivity and missed work costs the US economy about 1.8 Billion dollars a year.
As a board-certified psychiatrist, researcher and women’s health expert, I have seen first-hand how women’s fears and confusion about using hormones has led them to opt out of treatments that can minimize their symptoms and prevent disease as they age.
I’ve seen women have decreased confidence because they have experienced forgetfulness and brain fog during presentations. I’ve treated women who have reported having hot flashes that have caused overheating at work, leading to worsened productivity. In some of the cases the anxiety due to these symptoms led to avoidance of the workplace and missed days at work. Approximately 1 in 4 women (26.9%) used hormonal therapy in 1999, according to the National Health and Nutrition Examination Surveys. That rate declined to approximately 4.7% (1 in 20 women) by March 2020. This was largely due to the 2002 Women’s Health Initiative study, which stated that MHT (Menopause Hormone Therapy) carried increased risks of cancer, cardiovascular disease and dementia.
The WHI study in in 2002 was found to be flawed because participants on average were older and further along in the post-menopausal transition rather than newly menopausal women. These older women carried higher risks of cancer and heart disease due to age alone. The study’s conclusion led to overestimates in negative outcomes of MHT use, such as cancer, cardiovascular events and dementia. The reality is that when women wait too long to start MHT or don’t take it at all, they may suffer with symptoms that impair their quality of life. They may also experience an increased risk of developing negative health outcomes such as the genitourinary syndrome of menopause and osteoporosis, one of the leading causes of disability in postmenopausal women.
The WHI study also led to a black box warning on MHT, which caused hesitancy among both patients and health care professionals to initiate or continue use of MHT. We now know that osteoporosis, UTIs, and symptoms of depression may all be mitigated by MHT. Hormones impact all organ systems and a reduction in these hormones over time may impact multiple organs in the body. Reducing UTIs in midlife and post-menopausal women may even save lives due to decreasing the risk of systemic bodily infections, sepsis and even death due to infections. Reducing osteoporosis may lead to less injury in midlife, less pain and less disability.
Following the press conference, the FDA sent an email stating that their decision to remove the black box warning was based on a comprehensive review of the scientific literature, an expert panel in July 2025 and the public’s desire for clarity on this topic. The agency reported that it is working with companies to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer and probable dementia.
Studies suggest that when women seek support with MHT early in the transition, the outcome of symptoms are more likely to improve and this is particularly true for some of their mental health symptoms such as symptoms of depression. However, even if a woman is postmenopausal, MHT may help alleviate symptoms, especially pain and discomfort related to the genitourinary symptoms of menopause as seen in the case of local or vaginal hormones. Knowing which MHT is safe and at which stage of menopause to use it is a decision that is best made within a doctor-patient relationship where the risks versus benefits are thoroughly reviewed.
As an advocate for women’s mental health, this gives me hope. As a board member of national non-profit Let’s Talk Menopause, I have been a vocal advocate for change in the menopause and mental health space.
To help patients and professionals to correctly identify these symptoms as being related to menopause instead of other mental health conditions, I developed the TIES Method:
- The “T” in TIES is for thinking issues, such as forgetfulness and executive functioning problems known as brain fog.
- “I” is for identity issues. Women may report that they feel like they don’t know who they are anymore.
- “E” is for emotional issues, such as symptoms of anxiety and depression.
- “S” is for sleep issues, which may disrupt the ability to regulate mood and think clearly.
Studies have shown that early intervention with MHT may ease some of these TIES symptoms so that women may gain relief, improve their quality of life and hopefully remain in the workplace. However, MHT alone is not enough. Workplaces should consider educating managers and employees about how the menopause transition may impact them in the workplace. Workplaces should consider putting in place policies to support women going through the transition such as environmental supports for regulating the temperature for those experiencing hot flashes. Women may benefit from behavioral therapies that help them to get better sleep and to support them when they are having mental health challenges due to their menopause symptoms.
It is important that patients and healthcare professionals understand the effects of Monday’s press conference and begin to spread awareness in communities. It has been over 20 years since a message of fear stood in the way of women receiving the support and treatment they deserve to navigate and thrive during the menopause transition. Let’s hope that we can spread this message of hope so that women everywhere can finally receive that support.