In a pivotal move, the US Food and Drug Administration on Monday announced it is taking steps to remove the lengthy “black box” warning on many hormone treatments for women with menopause symptoms — a shift expected to give women more options for treatment and generate a flood of new prescriptions, reports BritPanorama.
Hormone therapy has long been on the market, but prescriptions plummeted after 2003, when the warning described increased risks of cardiovascular disease, stroke, breast cancer and dementia.
Prescribing requires nuance, FDA officials explained. Hormones are advised for women younger than age 60 or within 10 years of menopause. Despite this, some women still face specific risks associated with hormone usage, particularly those at increased risk of blood clots or who have a history of breast cancer.
“Today, the U.S. Food and Drug Administration is requesting that drug manufacturers remove black box warnings from these products,” FDA Commissioner Dr. Marty Makary stated in an opinion in The Wall Street Journal. “These are the strongest drug warning the agency can require, and they have inappropriately scared women off from this life-changing, and sometimes life-saving, treatment.”
What changed around hormone therapy
The black box warning is the strongest type of alert the FDA places on a drug label. Since 2003, labels of menopause treatments that contain estrogen — including pills, patches, sprays and creams — have warned that their use can increase the risk of uterine and breast cancers, as well as strokes and blood clots. The labels also cautioned about an increased risk of dementia for women over the age of 65.
This warning was introduced following a large government-funded study, the Women’s Health Initiative, which revealed in 2002 that women taking estrogen hormones after menopause faced higher health risks compared to those who received a placebo. The study participants, with an average age of 63, were well past menopause when they began hormone therapy.
Following the study and changes to drug labeling, physicians became hesitant to prescribe hormone therapy, resulting in a sharp decline of over 70% in prescriptions. In the late 1990s, more than 1 in 4 postmenopausal women were using hormones for symptoms such as hot flashes, mood swings and night sweats, but by 2020, that figure had dropped to about 1 in 25.
The consequence has been the undertreatment of symptoms that can be debilitating for women in midlife.
“It’s been a total horrible tragedy that so many millions of women have been deprived,” said Dr. Erika Schwartz, a New York-based internist and author of several books on hormone therapy. “Chronic illnesses like heart disease, Alzheimer’s, osteoporosis, cancer, they are diseases of aging, and one reason is the loss of hormones.”
More recent analyses of the Women’s Health Initiative show that hormone therapy initiated in women younger than 60 or within 10 years of starting menopause can be more safely managed to alleviate menopausal symptoms, provided they do not have contraindications such as a history of hormone-sensitive cancers.
“To this day, I still have patients coming in telling me their obstetricians or gynecologists have said to them they shouldn’t be taking hormones, because they’re going to get cancer. And not only will they not get cancer, the hormones will protect them from cancer,” Schwartz affirmed. “We have the data.”
In July, the FDA convened a panel of experts to discuss the benefits and risks of hormone replacement therapy. The panelists strongly recommended the removal of the warning label.
“I am begging the FDA, and all of us are begging, please remove the box label,” Dr. JoAnn Pinkerton, a professor of obstetrics and gynecology at the University of Virginia School of Medicine, implored. “And please stop harming women.”
In October, Makary mentioned in a podcast that the agency was engaged in “serious discussions” regarding the black box warning. He described the situation as “one of the greatest screw-ups of modern medicine,” indicating that it has led to 50 million women being denied vital therapy.
Changing views on menopause
The FDA action coincides with various policy movements across the country aimed at enhancing menopause care. Much of this legislation relates to insurance coverage, awareness, education, clinician training, and workplace conditions concerning menopause.
“When we think about the timing of this announcement, it’s not just the FDA making a move. It comes in the good company of now 19 states, red and blue alike, introducing more than 35 bills to improve menopause care,” noted Jennifer Weiss-Wolf, executive director of the Birnbaum Women’s Leadership Center at New York University School of Law.
“All these things are happening at the same time, and that’s in part because there is a loud and proud movement making these demands now, insisting that menopause care be equitable and treatments accessible,” said Weiss-Wolf, emphasizing the need to displace misinformation surrounding menopause.
The long-anticipated removal of the warning on hormone therapy reflects significant changes in understanding and addressing menopause care. Experts suggest that this decision will facilitate better accessibility to treatment, particularly estrogen therapy, for midlife women.
“Estrogen is one of the primary drivers of the heart,” said Dr. Jayne Morgan, a cardiologist based in Atlanta. “Once [estrogen] runs out, it’s just like a car; the car begins to sputter.”
As the FDA aligns itself with evolving perspectives on menopause treatment, the implications for women’s health could be profound, leading to improved quality of life for millions.
