FDA chief says warning labels deterred women from using menopause hormone therapy: “It’s an American tragedy”

The U.S. Food and Drug Administration will remove the “black box” warning labels on many hormone therapy drugs used for menopause and perimenopause symptoms — a major turnaround that’s likely to encourage more women to seek treatment. FDA Commissioner Dr. Marty Makary said in an exclusive CBS News interview that the change ends a decades-long “fear machine,” and he called the demonization of menopause hormone therapy, also known as hormone replacement therapy (HRT), “an American tragedy.”

“With the exception of vaccines or antibiotics, there’s no medication that can improve the health of women on a population level more than hormone replacement therapy,” Makary told senior correspondent Norah O’Donnell, explaining that studies show that menopause hormone therapy can reduce the risk of heart attacks, the leading cause of death in women.

The products affected by this change include medicines containing both estrogen and progesterone, systemic estrogen and topical estrogen.

The “black box” warning labels were based on what many experts now consider flawed research on HRT from more than 20 years ago. Part of the criticism is that back in 2002, researchers on the Women’s Health Initiative study overstated the risks of breast cancer because the data focused on older women.

More recent studies have shown the benefits outweigh the risk for many women if hormone therapy is used in the early years of menopause, before the age of 60.

“We now have a more nuanced understanding, and we want to put that fear machine in its proper context and let people know that there are tremendous long-term health benefits,” Makary said.

In addition to heart health, those benefits include lowering the risk of cognitive decline or Alzheimer’s and preventing osteoporosis, a major factor in hip fractures.

Hormone therapy can help ease menopause symptoms, which can be debilitating, taking both a mental and physical toll. There are a wide range of symptoms, including hot flashes, insomnia, night sweats, mood swings, joint pain, weight gain and more — with some experiencing more intense effects than others.

Menopause typically occurs in a woman’s late 40s or early 50s, when the ovaries produce less estrogen and menstruation stops. Perimenopause refers to the transitional years leading up to it.

What Studies Say Now

Over the past two decades, fears about breast cancer led doctors to steer millions of women away from hormone therapy.

“It’s an American tragedy. I do think it’s one of the biggest mistakes in modern medicine,” Makary said, denouncing the “groupthink” among doctors in the wake of the 2002 study.

As a result, he told CBS News, “50 to 70 million women over the last 23 years have been denied the incredible, life-changing, life-saving benefits of hormone replacement therapy because of the dogma.”

Those millions, he said, included his own mother.

“She had gone through perimenopause right around that time, but [was] never offered this therapy,” even though she was a good candidate for it. “Well, she went on to have two different falls recently where she had bone fractures. … And I can’t help but think if her bones had been stronger from hormone replacement therapy, she wouldn’t have gone through that.”

Menopause significantly speeds bone loss and increases the risk of osteoporosis, according to the Endocrine Society, an international medical organization. The group says 1 in 2 postmenopausal women will have osteoporosis, and most will suffer a bone fracture during their lifetime, which can lead to a cascade of other health problems.

Makary added he knows breast cancer is a sensitive topic that needs to be treated very carefully, but said no clinical trial has ever shown that hormone therapy increases a woman’s risk of dying from breast cancer.

One of the things scientists have learned, he said, is that hormone therapy is best started soon after a woman’s body stops producing estrogen.

“Hormone replacement therapy for postmenopausal women needs to be started within 10 years of the onset of menopause or perimenopause, and generally, the rule of thumb is not to start it after age 60,” Makary said. After around 60, aging and lack of estrogen mean blood vessels have begun to harden and narrow, raising the risk of stroke and heart attack; taking estrogen earlier can help prevent that.

Women should discuss the best options with their doctor.

“Look, I’m a regulator. I don’t want to tell people what to take. And I’m not prescribing anything,” Makary said. “But we want people to have the right information. And part of that is addressing this fear machine that has been going on for 23 years, that has been magnified by the FDA’s ‘black box’ warning on estrogen products for perimenopausal women.”

Non-Hormonal Therapy Treatments

While hormone therapy is the most effective treatment for hot flashes and night sweats, it is not suitable for everyone, especially women with a history of breast cancer.

Earlier this month, the FDA approved a new, non-hormonal option called Lynkuet, known generically as elinzanetant. The drug is the second medication to directly target the brain pathways involved in body temperature control. The first, called Veozah, was approved in 2023.

Despite how common menopause is, research funding to study it has historically been limited.

Even medical education on the topic has been limited, Makary said.

“The general philosophy was, why are we teaching about this, about menopause? Because there’s nothing we can do for it,” he said. “Well, that dogma, unfortunately, resulted in a lot of omission of menopause in medical education.”

But, with more women in the field, that’s starting to change.

“It’s been a male-dominated culture in the medical establishment, historically. Now, roughly half of our medical students at Johns Hopkins were women, and that’s a trend nationwide,” Makary said. “And they’re starting to say, ‘Hey, wait a minute, this is something where women are coming to their doctors and they’re not getting the right answer.'”