FDA changing ‘outdated’ black box warning for menopause treatment

The lengthy “black box” warning on menopause treatments is finally undergoing some changes.

Research published in 2002 had shown that menopause hormone therapy carried a risk of cancer and other serious conditions — which had naturally scared off many patients from taking it, as well as doctors from even describing it.

But new research in the years since then has painted a different picture — and the FDA is finally doing something about it, removing the strongest type of warning on many pills, patches, injections and creams used for menopause and perimenopause symptoms.

This morning, the Department of Health and Human Services announced that it will be removing “misleading FDA warnings on hormone replacement therapy.”

“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” said Secretary Robert F. Kennedy.

“For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”

Medical professionals have come out in support of the move.

“The black box warning has been enough of a deterrent to prevent [doctors] from offering it to their patients,” Dr. Nora Lansen, a board and Menopause Society-certified family physician and Elektra’s Chief Medical Officer, told The Post.

“Clinicians who provide menopause care have known for a long time that the black box warning on menopause hormone therapy should not be there. We’ve known that hormone therapy is safe for many women and does not carry the level of risk that is highlighted on the warning.”

The warning was first added after a large study from 2002 found that menopausal women taking estrogen pills had higher risks for some kinds of cancers, heart disease and stroke.

However, these risks may not apply to all women.

“In the decades since, we’ve reexamined the data and found that, yes, a high risk of developing breast cancer does exist for some people who use menopause hormone therapy (MHT), but not for all,” said Lansen.

In fact, she said, the associated risk of developing breast cancer is actually low.

“With a better understanding of the research, we’ve begun to realize that MHT is a safe and effective treatment for a broader range of patients than we had previously thought,” she explained.

And as new medications have come onto the market, the safety profile has gotten even better.

And research presented at the Menopause Society’s 2025 Annual Meeting found that women who started HRT during perimenopause had 60% lower rates of breast cancer, along with fewer heart attacks and strokes.

When to start

Considered a first-line treatment, hormone replacement has offered relief for several symptoms, such as hot flashes, mood swings, vaginal dryness and more.

But Lansen noted that when you start these hormones matter — and earlier is better.

“There is a much higher risk of adverse outcomes if a patient begins MHT more than 10 years after their final menstrual period and/or over the age of 60,” she said.

What does the change mean for women?

And with these new updates, Lansen and other medical experts hope more women will be able to use this treatment.

“The removal of the black box warning from menopause hormone therapy will hopefully deter fewer clinicians from prescribing it and will increase access to this medication that is extremely safe and effective for symptoms of menopause, particularly incapacitating hot flashes and night sweats,” she said.

There are still precautions to keep in mind when considering hormone treatments though.

“Consistent breast cancer screening is still recommended while using MHT,” Lansen added. “There are some people — such as those with a personal history of breast cancer — for whom MHT remains unsafe.”

Overall, though, the black box changes could see an increase in the number of women using menopause treatments.

“As the FDA continues to expand approval of menopause treatment options that research has shown to be safe, the result is increased access to safe, effective, and insurance-covered treatments,” said Lansen. “The removal of outdated black box warnings will help to continue to increase access.”