Experts say there is a lack of menopausal care, leading to delays in care.
Dr. Stéphanie Fabion, president of the Menopause Society, said medical schools need more training on menopause to prevent misdiagnosis and improve patient care.
For the past decade, Dr. Heather Hirsch has been trying to convince women that hormone therapy drugs are the best way to treat menopausal and perimenopausal symptoms. But warning labels about estrogen scare many women away from getting the care they need.
Now, the Food and Drug Administration is asking drug companies to remove these labels, known as black box warnings, on hormone therapy drugs that contain estrogen. This change could be a game-changer in helping more women cope with menopausal and perimenopausal symptoms, from increased urinary tract infections to night sweats.
“The label was outdated and harmful,” said Hersh, a physician and founder of the Brigham and Women’s Menopause Clinic who testified before the FDA this summer to remove the label. “This prevents too many women from getting the care they need.”
A 2002 Women’s Health Initiative (WHI) study linked hormone therapy to a slightly higher risk of breast cancer, heart attack, and stroke in postmenopausal women. This later-recognized risk was primarily seen in women who were older when they started hormone therapy.
The impact of this research touched millions of women.
The use of hormone therapy decreased from about 40% in 1999 to about 5% in 2020, according to the Journal of the American Medical Association.
This caused women to unnecessarily experience symptoms such as hot flashes and brain fog, Hirsch said.
The announcement was made on November 10 by Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty McCulley.
“Tragically, tens of millions of women have been denied the life-changing long-term health benefits of hormone replacement therapy because of medical dogma rooted in risk distortions,” said McCurry. “For too long, women’s health issues have been undervalued. Women and their doctors should make decisions based on data, not fear.”
The government recommends that hormone therapy be started within 10 years after menopause or before the age of 60.
What is a black box warning?
A black box warning is the highest safety label the FDA can put on prescriptions. Since 2003, all hormone treatments (tablets, creams, sprays, and patches) containing estrogen have had black box warnings.
A black box warning does not mean the drug is unsafe. That means increased risk.
Warnings about estrogen include risks of breast cancer, blood clots, stroke and dementia.
This summer, the FDA convened a committee to discuss changes to warning labels. Some doctors have called for warnings on patches and creams to be removed, saying research suggests they are safer than pills because estrogen doesn’t enter the bloodstream. Some wanted this warning removed from all estrogen therapy.
What changes with hormone therapy?
Removing the warning label will change the way prescribers treat menopausal women. Warning labels often prevented doctors from prescribing estrogen, and even when doctors did prescribe it, they made women fear the treatment.
“This is truly a historic day and a massive re-education for everyone,” says Monica Molenaar, co-founder of Alloy, a telemedicine company that treats menopause and menopause. “Women no longer need to fear the very things that make them feel good.”
It could also help repair the doctor-patient relationship torn apart by the warning, said Dr. Colin Meng, an obstetrician-gynecologist and Alloy’s director of clinical innovation and education. “We tell our patients one thing, but the label says something else. The fear from this box has prevented patients from trusting what their doctors say.”
A wide range of medical experts, from urologists to gynecologists, traveled to Washington to show support for the announcement.
Urologist Dr. Rachel Rubin says “a whole generation of clinicians have never been taught the details” of how vaginal hormones can help treat the genital, sexual and urinary symptoms of menopause. She advocated for vaginal estrogen to be delabeled, although it does not treat hot flashes or night sweats, but does help prevent urinary tract infections and painful intercourse.
More than 40% of U.S. women are perimenopausal, menopausal, or postmenopausal. And most women’s health deteriorates during menopause. Menopause can last up to a third of a woman’s life.
Removing the label will allow more clinicians to talk to patients about hormone therapy and discuss the exact risks. Molenaar said this change will not only make a difference for women in the United States, but for women around the world, with other countries likely to follow suit.
Armed with this information, more women will be able to better advocate for themselves during medical appointments, says Hirsch, who recently published “The Perimenopause Survival Guide.” They will feel comfortable seeking hormone therapy.
Hormone therapy, which consists of estrogen and progesterone (or estrogen only for women without a uterus), is the most effective treatment for menopause and is the first recommended treatment, according to the North American Menopause Medicine Society. Women with breast cancer face increased risks from hormone therapy, and high doses of estrogen are not usually prescribed.
Research also shows that hormone therapy may benefit women’s hearts and reduce the risk of Alzheimer’s disease.
“This trumps all politics,” Molenaar said. “We have real science, information and decades of evidence, and there is no reason why women should continue to be victimized.”
Laura Trujillo is a national columnist focused on health and wellness. She is the author of “Stepping Back from the Ledge: A Daughter’s Search for Truth and Renewal” and can be reached at ltrujillo@usatoday.com.
