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, and the narrative that hormones were unsafe was perpetuated.
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. In an interview with CBS, urologist and menopause expert Dr. Rachel Rubin said that hormones are like the body’s gas tank. When they fluctuate during perimenopause and halt in menopause, “every cell in your body will feel the consequences.” 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. But the black box warnings meant only about 1 in 25 American women accessed HRT to help them through menopause.
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.
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.
