A Monumental Step Forward for Women’s Health  

By: Robert A. DeSantis, MD, FACOG  

Recently, the United States Food and Drug Administration (FDA) made a historic announcement that it would be officially removing the black box warning from hormone replacement therapies for perimenopausal and menopausal women.  

The announcement was heartfelt, acknowledging that the FDA’s decision to add the black box warning over two decades ago was misguided and made without proper evidence.  

“For the first time in a generation, the FDA is standing with science and standing with women,” Robert F. Kennedy Jr., said. “The era of ignoring women’s health is over. The era of patronizing women is over. The FDA will follow the science and America’s women will finally get the care, the respect and the honesty they deserve.”  

What is menopause?  

Menopause is a natural process experienced by every woman at some point. 

According to an Oct. 2024 article from the World Health Organization, “For most women, menopause is marked by the end of monthly menstruation (also known as a menstrual period or ‘period’) due to loss of ovarian follicular function. This means that the ovaries stop releasing eggs for fertilization.”  

Menopause symptoms include but are not limited to hot flashes, night sweats, vaginal dryness, painful sex, anxiety, tension, nervousness, depression, low sex drive, joint pain, back pain, sleep disturbance, increased hair growth, weight gain, gastrointestinal problems, incontinence, bladder infections, headaches, memory loss, fatigue, chest pain, palpitations and more. Women experience these symptoms to varying degrees. For some, the symptoms are mild, for others, they can be bothersome or even debilitating.  

What does HRT do? 

Physicians have acknowledged for decades that the shift in women’s hormone levels around the time of menopause lessens a woman’s quality of life exponentially. Hormone replacement therapy began in the 1940s. This led to the widespread use of HRT, which has been used to treat menopause symptoms in the United States since the 1960s.  

The U.S. Department of Health and Human Services says, “HRT is FDA-approved for relief from common menopausal symptoms, such as hot flashes and night sweats (also known as vasomotor symptoms) and symptoms due to changes to the vagina, vulva and urinary tract caused by decreased estrogen, also known as vulvovaginal atrophy or genitourinary syndrome of menopause.”  

In the official press conference, Kennedy stated, “In short, it restores balance, not just hormonally, but emotionally and physically, that is why in 1999 ‘approximately 27% of postmenopausal women took hormone replacement therapy.’”  

In fact, around 40% of women between the ages of 50-59 were on some form of HRT up to mid 2002.  

There are several types and forms of HRT, but most replacement includes estradiol and progesterone. Whether or not a woman needs progesterone depends on their symptoms and if they have undergone a hysterectomy.  

What is a black box warning?  

A black box warning is the most severe warning that can be given to a drug or pharmaceutical product by the Food and Drug Administration. For the better part of two decades, when patients opened the packaging of their prescribed HRT medication, a physically printed black box label appears on warning of adverse effects such as cardiovascular disease, breast cancer uterine cancer and probable dementia and other life-threatening health issues. The black box warning further stated that there was an increased risk of pulmonary embolism, deep vein thrombosis, stroke and heart attack.  

This label, which was added to all HRT products in 2003, essentially scared an entire generation of women away from using this FDA-approved drug. Simply stated, approximately 50 million women have been denied appropriate therapy for the past 23 years.  

Why was it added?  

The black box warning was added because of the findings from the Women’s Health Initiative. The Women’s Health Initiative was started by the National Heart, Lung and Blood Institute in 1991.  

According to the organization’s website, the initiative, “is a long-term national health study that focuses on strategies for preventing heart disease, breast and colorectal cancer and osteoporosis in postmenopausal women. These chronic diseases are the major causes of death, disability and frailty in older women of all races and backgrounds.”  

This study is technically the largest women’s health study ever conducted, but it was intrinsically flawed. Most health care professionals now accept this as a fact. The most harmful and most remembered finding from this study was that it increased the risk of developing and dying from breast cancer.  

Why is the warning being removed now?  

After more than two decades of continued study, scientists and medical officials have now disproved the results from the Women’s Health Initiative, identifying several specific issues with the original study. One being the type of HRT used, synthetic estrogen (Premarin) and medroxyprogesterone acetate (a progestin), a form of HRT not commonly prescribed today. As well as the fact that the average age of women included in the trial, which was 63 years, meaning the population sampled was significantly older than the average age of women first experiencing symptoms.  

FDA commissioner Marty Makary said in a September 2024 podcast appearance that though the “data never supported” the conclusion that HRT increases breast cancer rates, “80-90% of people, including doctors” still believe it does.  

An article published on the JAMA (Journal of American Medicine) website on Nov. 10, 2025, titled “Updated Labeling for Menopausal Hormone Therapy” asserts, “The increased risk in breast cancer cases observed in the original WHI study (1 additional non-fatal breast cancer diagnosis per 1000 women treated in a year) has been subsequently recognized to be attributed to the particular progesterone formulation used in the study, medroxyprogesterone acetate—a formulation that is not in common use today for hormone therapy.”  

According to the U.S. Department of Health and Human Services, “Studies have provided evidence that starting HRT within ten years of the onset of menopause can have numerous benefits which, for most women, outweigh potential risks. Benefits include a reduced risk of all-cause mortality and fractures. HRT has also been associated with 50% reduction in heart attack risk, 64% reduction in cognitive decline, and 35% lower risk of Alzheimer’s.” 

Who is an appropriate candidate for HRT?  

There are very few absolute contraindications to the use of HRT. All women around the age of 50, who are experiencing menopause symptoms, should consider speaking with their healthcare provider about how to manage them. Also, remember the time around menopause can be quite bothersome for many women and treatment plans can be discussed during the perimenopausal time. When it comes to female health, I see many women accept their symptoms as their reality. It is important to know that you have options, and HRT is a good option for many women. 

“Current evidence suggests that hormone therapy initiated within a decade of the onset of menopause 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,” said JAMA in the previously mentioned Nov. 10, 2025, article.  

It is important to note that HRT products will continue to have a warning for increased risk of developing endometrial hyperplasia for those patients who still have a uterus and who take estrogen products alone. It is still advisable to add progesterone in this case, to reduce that risk.  

What does this mean for women’s health?  

This black box removal may be the biggest thing to happen in women’s health in 30 years, and I believe that it will have profound impacts on the health of women.  

In the FDA Direct Podcast, podcast host and FDA Commissioner Marty Makary, MD, said, “I think sometimes there may be no other medication in the modern era, besides say antibiotics and vaccines, that can improve the health outcomes of women at a population level more than hormone replacement therapy.”  

About Robert A. DeSantis, MD, FACOG: Robert A. Desantis is a board-certified Obstetrics and Gynecology physician. He has been in practice for 30 years. Dr. DeSantis has devoted a significant part of his career to minimally invasive gynecologic surgery and the treatment of menopausal disorders. He is a hormone replacement doctor who is currently accepting new patients. To schedule an appointment, please call 601-477-2226 or 601-649-5421.