Women should not suffer through menopause with hot flashes, night sweats and poor sleep. That's the message from FDA Commissioner Dr. Marty Makary.
The agency announced it will remove "black box" warning labels from estrogen-based hormone therapy, which treat the symptoms of menopause, saying the warnings have made women scared to try the therapy and doctors reluctant to prescribe it.
The warnings stem from the early 2000s when data from the Women's Health Initiative study found hormone therapy increased risks of heart attacks, strokes, blood clots and breast cancer.
But, women in that study were given a type of hormone therapy formulation that is no longer commonly used. And the average age of women in the study was 63, which is now considered too late to start hormone therapy.
Now, experts say there's a lot more known about safe and effective combinations, when therapy is initiated earlier.
"If you're under age 60 or within ten years of menopause onset, when you start hormone therapy, you're going to see improvements in hot flashes, sweats, fewer sleep disruptions, " says Dr. JoAnn Pinkerton, a menopause expert at the University of Virginia Health.
She also points to protection against bone loss and fractures, as well as potential benefits for heart health, brain fog and overall quality of life.
"When it's dosed appropriately, hormone therapy can be given safely and have multiple benefits," she says.
But here's an important reality check: "Not all women can take hormone therapy," Pinkerton says. She says some women have medical conditions or symptoms that can make hormone therapy risky.
"It's really important that women have a discussion with an informed health care provider because you want to know what are the benefits and risks for you," Pinkerton says.
So, here are some things to consider when talking to your healthcare provider about hormone therapy for menopause.
1. When should you start hormone therapy?
Experts recommend starting estrogen therapy before the age of 60 or within ten years of the start of menopause — which begins one year after your last period. Many women remain on birth control through perimenopause, which can help with hot flashes and night sweats as hormones fluctuate.
Once you're through the menopause transition and you don't need pregnancy prevention, then it doesn't make as much sense to use birth control, Pinkerton says, because it's typically stronger than the amount of estrogen used in menopause hormone therapy, so that's a good time to talk to your provider about hormone therapy options.
2. How long should you be on hormone therapy?
In general, women stay on hormone therapy for three to five years, but that's not a hard and fast rule.
"For women who have persistent symptoms or bone loss — which can be treated with hormone therapy — we will continue it," Pinkerton says. But, it's important to keep assessing each year. "It's about working with the patient to come up with what's safest and best," Pinkerton says.
"We don't take someone off [hormone therapy] just because it's been three to five years, " says Lauren Streicher of Northwestern University. She points to differences in how long menopause symptoms persist, noting that Black and Hispanic women tend to experience symptoms for longer time periods.
3. How has hormone therapy changed?
Science has evolved over the last 20 years, since the results of the Women's Health Initiative came out. And, importantly, there's been a shift in how estrogen is administered, as well as new formulations of hormones. For instance, many women are now prescribed patches instead of pills.
"We know that oral therapy can slightly increase the risk of blood clots and stroke," Pinkerton says, so providers often opt for transdermal therapy for women at risk of these conditions. Transdermal patches, gels or rings deliver estrogen that is absorbed directly through the skin which research shows can lower the risk of blood clots.
Also, women enrolled in the WHI study were given synthetic progestin which was linked to an increased breast cancer risk. But, now doctors can prescribe micronized progesterone that has fewer side effects. Micronized progesterone is a bioidentical hormone with a molecular structure identical to the estrogen produced in the ovaries.
4. Do all estrogen products carry the same risks?
No. Local estrogen, such as low-dose vaginal creams, target symptoms such as vaginal dryness, painful sex, bladder control and reduced risk of urinary tract infections. This is different from systemic estrogen, delivered through pills, patches or gels. Systemic estrogen is a higher-dose treatment that circulates throughout the body to address symptoms including hot flashes and night sweats, and can carry a higher risk of side effects.
"I think most would agree that with local, low-dose vaginal estrogen therapy that the risks are negligible," says Dr. Monica Christmas, director of the Menopause Program at the University of Chicago. "For local, vaginal estrogen, it's reasonable to remove the black box warning. I don't think we need to scare people unnecessarily," Christmas says.
However, for higher dose, systemic estrogen therapy — which is absorbed into the blood stream — including estrogen pills, Christmas and other menopause experts are more equivocal about removing the black box warning.
"It provides a pause," Christmas says, and prompts patients to discuss the risks with their providers."
5. Who should avoid hormone therapy?
Some women have medical conditions that can make hormone therapy more risky. This includes women with estrogen sensitive breast or uterine cancer, and women who are at high risk for or have had a heart attack, stroke, blood clot, or pulmonary embolism.
"It's really important that women have a discussion with an informed health care provider because you want to know what are the benefits and risks for you," Pinkerton says
6. Are there alternatives for women who don't want to take hormone therapy?
The Food and Drug Administration has approved two non-hormonal medications to treat severe hot flashes in menopause. According to the FDA, about 80% of menopausal women experience hot flashes which can include sweating, flushing and chills that last for several minutes.
Lynkuet, which was approved last month, and Veozah, which was approved in 2023, are both oral medications that work by targeting the neural activity that causes hot flashes during menopause. Lynkuet has been shown to reduce the severity and frequencies of hot flashes.
The National Institutes of Health has tips for managing symptoms, including limiting alcohol and caffeine, and maintaining a healthy body weight. And early-stage research shows hypnotherapy and mindfulness meditation may help manage hot flashes.
Some people find herbal remedies helpful. A study of medicinal plants including sage, lemon balm, red clover and licorice finds they may be effective in the treatment of menopausal symptoms like hot flashes.
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