Things Women Should Know About the Black Box Lift on Hormone Replacement Therapy by the FDA
Recently (Nov ’25) the FDA decided to lift/remove the “black Box” warning on hormone replacement therapy (HRT) for women. The FDA's black box warning on HRT was first introduced in 2002, following the Women's Health Initiative (WHI) study, which raised concerns about the risks associated with hormone therapy. The WHI study suggested the risks of HRT (increased incidence of breast cancer and heart disease) outweighed any benefits especially in certain age groups of women. For many women, this warning was enough to deter them from considering HRT, despite the severe symptoms of menopause. The rate of women over age 50 who were utilizing HRT went from 25% in 2000 to current levels near 4-5%.
However, recent studies and expert opinions have led to a reevaluation of these risks. According to a 2020 study published in The Lancet, the risks may not be as significant as previously thought, especially for younger women or those within 10 years of menopause onset.
This change in mind set has led to current FDA commissioner Dr. Marty Makary to recommend the removal of the warning and the advocation of HRT in peri and post-menopausal women. He has written that the current evidence suggests that hormone therapy initiated within a decade of the onset of perimenopause has been associated with numerous long-term health benefits, including reduced vasomotor symptoms, without significantly affecting atherosclerotic cardiovascular disease among younger postmenopausal women aged 50 to 59 years. By removing the black box warning, the FDA hopes to alleviate unnecessary fears and enable more women to consider HRT as a viable option. It's a decision that aligns with current medical thinking, emphasizing the importance of individualized care.
HRT is primarily recognized for its effectiveness in alleviating common menopausal symptoms like hot flashes, night sweats, and mood swings. For many women, these symptoms can be severe and debilitating, impacting their quality of life. But the vast benefits of HRT should also be evaluated and considered when deciding on the right dose/type of HRT intervention.
Hormone therapy has been associated with a 25% to 50% reduction in fatal cardiovascular events (the leading cause of death in women), a 50% to 60% reduction in bone fractures, a 64% reduction in cognitive decline, and a 35% decreased risk of Alzheimer disease.
A study in the Journal of the American Medical Association highlights that women using HRT report significant improvements in sleep quality and overall well-being. This reinforces the notion that HRT can be a powerful tool in enhancing daily life during menopause. While it's not a one-size-fits-all solution, its potential benefits are undeniable when appropriately prescribed. By considering HRT, you might find a path to easier days and more restful nights during menopause.
Dr. Makary has been quoted as saying “with the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy.
The lifting of the black box warning will likely result in a flood of individuals searching for information which should stress the importance of personalized care in managing menopause and it’s symptoms.
All women are not equal, and their responses to HRT can be variable. Personalized care means tailoring HRT to your specific symptoms, risks, and health goals. It's an approach that respects your individuality and aims to provide the best outcomes. This involves initial consultation and regular check-ins with your healthcare provider to assess how well HRT is working for you. It allows for adjustments in treatment as needed, ensuring that your therapy remains effective and safe. By prioritizing personalized care, you engage in a proactive, informed approach to managing menopause.
Additionally, lifestyle changes can play a significant role in managing menopausal symptoms, either alongside HRT or independently. Diet, exercise, and stress management can all contribute to your overall well-being during menopause. Incorporating simple changes like regular physical activity or a balanced diet rich in calcium and vitamin D can also make a difference. Stress-reduction practices such as yoga or meditation can also help manage symptoms like mood swings and anxiety. By focusing on wellness, you can approach menopause with a well-rounded strategy. It's a reminder that small, consistent efforts in self-care can lead to significant improvements in how you feel.
