Dr. Heather Hirsch is the author of The Perimenopause Survival Guide and the founder of the Menopause Clinic at Brigham and Women’s Hospital.

For the past decade, Dr. Heather Hirsch has tried to convince women that hormone therapy drugs are the best way to treat symptoms of menopause and perimenopause. But warning labels on estrogen have scared 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 containing estrogen. This change will be monumental in helping more women manage disruptive menopause and perimenopause symptoms ranging from increased urinary tract infections to night sweats.

“The label was outdated and harmful,” says Hirsch, a physician and founder of the Menopause Clinic at Brigham and Women’s who testified in front of the FDA to remove the labels this summer. “It led to so many women not getting the care they need.”

A 2002 Women’s Health Initiative (WHI) study linked hormone therapy to slightly higher risks of breast cancer, heart attacks and strokes in postmenopausal women. The risks, recognized later, were mostly found in women who were older when they started hormone therapy.

The ramifications from the study affected millions of women.

Use of hormone therapy dropped from about 40% in 1999 to about 5% in 2020, according to the Journal of the American Medical Association.

This led to women unnecessarily experiencing symptoms such as hot flashes and brain fog, Hirsch says.

Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary made the announcement Nov. 10.

“Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,” Makary said. “For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”

The administration recommends that hormone therapy starts within 10 years of menopause onset or before age 60.

What is a black box warning?

The black box warning is the highest safety label that the FDA can put on prescriptions. Since 2003, the black box warning has appeared on all hormone therapy including estrogen – pills, creams, sprays and patches.

A black box warning doesn’t mean a drug isn’t safe. It does mean it carries increased risks.

The warning on estrogen listed risks of breast cancer, blood clots, stroke and dementia.

This summer, the FDA held a panel to discuss changes in the warning labels. Some doctors have pushed for the removal of the warning on patches and creams, which research has suggested are safer than pills because estrogen doesn’t enter the bloodstream. Others wanted the warning removed from all estrogen therapies.

What will change with hormone therapy?

The removal of the warning label will change the way prescribers treat women in menopause. The warning labels often kept doctors from prescribing estrogen, and also made women fearful of the treatment even when prescribed by their doctor.

“This is really a historic day and is a massive re-education of everyone,” says Monica Molenaar, who co-founded Alloy, a telehealth company that treats perimenopause and menopause. “Women no longer need to be fearful of the very thing that makes them feel better.”

It also will help restore the doctor-patient relationship which was fractured by the warning, says Dr. Corinne Menn, an OB-GYN and Alloy's director of clinical innovation and education. "We are telling them one thing, but the label says something else. This fear from the box got in the way of patients being able to trust what their physicians were telling them."

A range of medical professionals from urologists to gynecologists were in Washington to show support of the announcement.

"An entire generation of clinicians were never taught the details," of how vaginal hormones can help treat ‍the genital, sexual and urniary symptoms of menopause, says Dr. Rachel Rubin, a urologist. She pushed for removing the label on vaginal estrogen, which doesn't treat hot flashes or night sweats, but helps prevent urinary tract infections and pain with sex.

More than 40% of U.S. women are in perimenopause, menopause or are postmenopausal. And most women are in worse health during menopause, which can last 1/3 of women’s lives.

The removal of the label will lead to more clinicians talking with patients about hormone therapy and be able to discuss accurate risks. Molenaar says this change won’t just make a difference for women in the U.S., but globally, as other countries likely will follow.

With this information, more women will become better advocates for themselves at medical appointments, says Hirsch, who recently published The Perimenopause Survival Guide. They will be less reluctant to ask for hormone therapy.

Hormone therapy consists of estrogen and progesterone (or estrogen only for women who do not have a uterus), and is the most effective treatment for menopause, and is the first recommendation, according to the North American Menopause Society. Women who have had breast cancer face increased risks from hormone therapy, and typically are not prescribed high doses of estrogen.

Research has also shown that hormone therapy can be beneficial to women's hearts and potentially could help decrease the risk for Alzheimer's disease.

"This supercedes all politics," Molenaar says. "We have true science, information and decades of evidence there is no reason why women should continue to be harmed."

Laura Trujillo is a national columnist focusing 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.

This article originally appeared on USA TODAY: FDA removes the black box warning on hormone therapy for menopause

Reporting by Laura Trujillo, USA TODAY / USA TODAY

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