Last week, the Food and Drug Administration (FDA) announced a major change in menopause treatment: It’s removing the black box warning on hormone replacement therapy (HRT) containing estrogen or progestogen, hormones that naturally decline during menopause. The labels on the products—offered to treat symptoms such as hot flashes, night sweats, and vaginal dryness—will no longer mention risks related to cardiovascular disease, breast cancer, and dementia.
The menopause experts Health spoke to see this as a step forward in women’s health, but they also suspect that the change will spark new questions about HRT. Here are four key things you need to know about hormone therapy.
The risks cited on the black box warning trace back to research from the Women’s Health Initiative in the early 2000s. Before then, HRT was routinely prescribed, Danielle Roncari, MD, MPH, an OB/GYN and the director of family planning at Tufts Medical Center, told Health. But the study found an increased risk of breast cancer, stroke, and heart attack in women taking the medication.
The average age of the participants in several key studies was in the 60s or higher—older and further from menopause than the typical population that uses HRT, Roncari said. Also, the medication used in some studies, a combined estrogen and progestin pill, is not commonly used today.
“The FDA has realized that you can’t take old data and apply it to new medications. And you can’t apply data in different populations across the board,” Elizabeth Poynor, MD, gynecologic oncologist, chair of Women’s Health & Gynecology at the Atria Health + Research Institute, and clinical professor at NYU Langone Medical Center, told Health.
“It was a blanket cautionary labeling. And it wasn’t done to harm people—it was just a quick snap judgment that unfortunately had a lot of ramifications for decades,” added Robin Noble, MD, MHCDS, MSCP, a practicing gynecologist and chief medical advisor at Let’s Talk Menopause, a nonprofit focused on menopause education and advocacy.
There’s no one-size-fits-all recommendation when it comes to taking HRT, experts said. Whether the medication is right for you depends on your age, where you are in the menopause transition, and your personalized risk factors.
Simply put: “The older we are and the more complicated our health histories are, the more risk we might have by starting hormones later,” Noble said. For instance, Roncari noted that the medication may not be right for women with a history of a hormonally sensitive cancer.
Poynor recommends starting the conversation with your doctor early, as patients younger than 60—or within 10 years of menopause, technically defined as going a full year without a period—tend to see the most benefit from hormone therapy. “Don’t wait around for everything to be totally disrupted,” she added.
The black box warning lumped all HRT together, but there are many different forms besides pills, including transdermal patches, local creams and gels, and vaginal rings. And medications don’t always just involve estrogen and progesterone—some regimens include testosterone, too.
The type of hormones used, the route of administration, and the dosage all influence how hormone therapy affects the body. For example, Noble said oral medication may be riskier for older patients, but those women tend to be excellent candidates for local vaginal estrogen, which can help with vaginal dryness, pain during sex, urinary urgency, and UTI risk.
Poynor added that she recommends transdermal patches as a first-line treatment over oral medications. Research shows it has fewer safety risks than oral hormone therapy, which has stronger absorption than the patches.
HRT is proven to address menopause symptoms like hot flashes and night sweats, Roncari said. But many people may not know about its other long-term benefits. Research shows it can actually reduce the risk of heart problems, osteoporosis, and potentially dementia.
“For too long, people have considered hormone therapy only as an option for really bad symptoms,” Noble said. “We need to be reframing this and recognizing that all women should have these options and be educated about them.”
