The FDA Is Removing Black Box Breast Cancer Warning From Hormone Replacement Therapies

Listen, the past year has been pretty bleak when it comes to health policy changes actually backed up by science. But this week, the FDA is making a move menopause experts actually agree with and have been asking for for decades. On Monday, the FDA announced that hormone replacement therapy (HRT) products will no longer carry black box warnings stating they cause increased risk of breast cancer, heart attack, and stroke. The label was added to these products in the early 2000s following the publication of the Women’s Health Initiative study, the results of which experts say were misinterpreted.

The FDA’s announcement states that the study “found a statistically nonsignificant increase in the risk of breast cancer diagnosis. The average age of women in the study was 63 years — over a decade past the average age of a woman experiencing menopause — and study participants were given a hormone formulation no longer in common use.” The black box label is now being removed “following a comprehensive review of the scientific literature, an expert panel in July, and a public comment period,” the agency said. In a video posted to X, FDA Commissioner Dr. Marty Makary explains how the original data was misinterpreted.

Hormone replacement therapy is used to treat symptoms of perimenopause and menopause, including hot flashes, sexual and genitourinary symptoms, and even loss of bone density. Tens of millions of American women are currently in menopause, and two million more are added to that total annually. Menopause experts have long touted the benefits of hormone replacement therapy, saying it is safe and effective and adds many more healthy years to a woman’s life. They say the black box warnings prevented many women from even considering HRT.

In an interview with 60 Minutes, longevity expert Dr. Peter Attia called the black box warning, which led to “a lost generation” of women going through menopause with zero treatment, “the greatest single failure of the modern medical system.” Women who entered and endured menopause in the last 25 years suffered unnecessarily, Attia asserts, because often physicians get hung up thinking about lifespan versus healthspan. Hot flashes, painful sex, and other common menopause symptoms don’t shorten a woman’s lifespan, he says, but they do shorten her healthspan — the number of years of her life she can be healthy, active, and feel able-bodied.

Of course, no treatment is right for everyone. Some health experts worry that the FDA’s verbiage around hormone replacement therapy erases that it can carry risks for certain patients. “I really worry about this overwhelming embrace of hormone replacement therapy without understanding the data,” said Dr. Leslie Cho, an interventional cardiologist and director of the Cleveland Clinic’s Women’s Cardiovascular Center, in an interview with CNN. A 2023 research review authored by Cho found that HRT may not be appropriate for women with congenital heart disease or high risk of breast cancer, among other risk factors.

Many doctors took to social media to celebrate the FDA’s announcement, saying their hope is that more women will now feel safe talking to their doctors about hormone replacement therapy and if it might be right for them. And that’s the real take-home point here — it’s OK to raise your perimenopause and menopause concerns with your provider and ask if there is a safe and effective treatment available for you.