FDA removes black box warning from hormone therapy for menopause
The FDA announced it would remove long-standing black box warnings from hormone-based treatments for menopausal symptoms such as hot flashes.
Fox – 5 New York
Julie Andresen couldn’t sleep.
She sweated through her pajamas and sheets every night. She was so exhausted that she considered quitting her job of 30 years as a program manager for the City of Phoenix.
Then came the hot flashes. Her sex drive felt almost non-existent. She got up several times during the night to go to the bathroom.
She saw her doctor and gynecologist. They both told her this was normal. What is the diagnosis? Middle age.
She has seen nine different doctors over five years, sometimes waiting more than three months for an appointment. She was told to ignore the symptoms and that they would eventually go away.
“The doctor asked me if I wanted night sweats or cancer,” said Andresen, 54, even though she had no family history of breast cancer. “I felt so terrible. Everything was so bad and I felt like no one cared about me.”
She eventually consulted a gynecologist at a concierge medical facility that does not have health insurance. Within a week, she was told she was perimenopausal and prescribed hormone replacement therapy.
After one year, symptoms such as night sweats had decreased from 87% to 2%.
Many women say they feel ignored, ignored, and gassed up by their doctors. If you say you feel anxious, they will prescribe antidepressants. If you complain that your joints hurt, they will tell you to stretch more. When you say sex hurts, they ask you to drink a glass of wine. So, why are your ears itching? It’s all in their head.
At a time when menopause is more talked about than ever and has grown into a $20 billion industry that includes everything from herbal supplements promoted by Drew Barrymore to cool bamboo robes, women still struggle to find care.
According to one study, one in five women will reach menopause one year before being diagnosed by a doctor. Another study showed that 5% of women seeking help for perimenopause or menopause saw 11 doctors before receiving help. Some people who are not covered by health insurance rely on concierge doctors who specialize in menopause. Some people have found peace of mind by using telemedicine companies for women. Women say they often have to seek help from their own doctors.
Changes are happening, including new guidance from the Food and Drug Administration on hormone replacement therapy, but women say not enough is being done. Although more doctors are becoming certified in menopause care and some states are considering requiring further education for medical students, women still often have to advocate for their health in ways that would never have happened to men.
“I was at a loss,” says Andresen, who pays $3,200 a year for access to experts. “I couldn’t find anyone to help me and I was paying a lot of money going from doctor to doctor. I needed to get my health back.”
“The panic was very real.”
Melissa Gordon noticed that no matter what she ate, she gained weight.
Her cholesterol skyrocketed and her blood sugar levels dropped.
She saw her doctor and gynecologist. They both told her that she was simply aging.
She was 38 years old.
Then the anxiety came over me and I felt so weak that I felt my face freeze. One doctor told her it might be multiple sclerosis. Another said it’s just in your head.
She saw seven doctors over the past few years before trying a women’s telemedicine company. The doctor reviewed her medical history, asked questions, and diagnosed her as perimenopausal this year. Gordon started hormone replacement therapy and says she now has almost no symptoms.
“When it got so bad, I felt like I was in a video game. The panic was so real,” says Gordon, a marketer and web designer in Los Angeles. “Once someone listened to me, everything changed. It was amazing.”
Finding a doctor who specializes in menopause can be difficult. According to the Society of Menopause Medicine, general practitioners are more likely to prescribe antidepressants than hormone replacement therapy.
Most doctors, including gynecologists, did not receive adequate training in menopause during medical school, according to a study published in the Journal of the Menopause Society. Of nearly 100 obstetrics and gynecology training program directors recently surveyed, fewer than one-third said they received training in their residency.
The Menopause Institute, a nonprofit organization that provides resources to medical professionals, certifies menopause care providers through exams and continuing education. Membership has rapidly increased in recent years, with the number of members ranging from certified doctors to pharmacists increasing from 1,000 10 years ago to more than 4,000.
The company recently launched a $10 million training program to help train more than 25,000 menopausal and perimenopausal health professionals.
Telemedicine, which has rapidly increased due to the impact of the new coronavirus infection, is also entering the market. From Midi to Alloy to Winona to Evanow, there are a variety of telemedicine companies for women, some of which accept insurance and others that offer their own medications and supplements.
Midi began in 2021 when Kathleen Jordan, a doctor, entered middle age and saw many of her friends struggling to find appropriate care.
She shared the women’s frustrations. Clinicians ignored their concerns. There was no menopause specialist nearby. And many women couldn’t afford a concierge doctor who specialized in menopause.
“All women should have access to good menopause care,” says Jordan, chief medical officer and co-founder of women’s telemedicine company Midi. “The most common comment after a visit to Midi is, ‘I finally felt like I was being listened to.’ They weren’t given the time they deserved.”
Perimenopausal and menopausal care can not only relieve women’s symptoms such as brain fog, frozen shoulders, and urinary incontinence, but also determine the health status of women in old age.
“For too long, we’ve expected obstetrics and gynecology to be responsible for everything in women’s health, but they can’t do it alone,” she says.
“I almost went crazy.”
Loredana Buonopane didn’t feel like herself.
She was anxious, had trouble sleeping, and felt like her emotions were out of control.
She met with her general practitioner and several gynecologists. Each doctor said she was not menopausal because she still had menstrual cycles and did not need hormone replacement therapy. Someone told her that taking estrogen was dangerous.
“I almost went crazy,” said Buonopane, 50, a stylist and vintage shop owner. “I’ve been thinking about how I can keep working when I’m feeling like this.”
She struggled to find a new doctor who would accept her insurance, and finally found one more than an hour from her home in New Jersey. The doctor put her on antidepressants, which, while approved to treat perimenopausal symptoms such as hot flashes, were not as effective as hormone replacement therapy.
“It helps a little bit,” said Buonopane, who is in perimenopause, which precedes menopause. “But that’s not what I need.”
New FDA guidelines direct drug companies to remove black box warnings on hormone replacement therapy drugs containing estrogen. This change is critical to helping more women manage menopausal and perimenopausal symptoms, from increased urinary tract infections to night sweats.
This warning has kept many women away from hormone replacement therapy for more than two decades, ever since a 2002 Women’s Health Initiative (WHI) study linked it to increased rates of breast cancer, heart attacks, and strokes in postmenopausal women. This later-recognized risk was primarily seen in women who were older when they started hormone therapy.
The impact of this study has affected millions of women, and over the past two decades, the use of hormone replacement therapy has fallen from 40% to 5%, as many doctors stopped prescribing it, and even if they did, women were reluctant to take it.
Menopause doctors say removing the label won’t change the risks, but it will allow more doctors to better understand menopause.
“It’s like we do all the research ourselves and then have to convince doctors to listen to us,” Buonopane says. “It’s shocking to not be able to get help at this age.”
Take advantage of women’s health
Menopause is big business, with more than 40% of American women in perimenopause, menopause, or postmenopause. And most women’s health deteriorates during menopause. Menopause can last up to a third of a woman’s life.
“Everyone is trying to take advantage of it,” says Monica Christmas, a physician and associate medical director of the Menopause Medicine Society. “It poses challenges not only for women but also for practitioners.”
We find hope in the proliferation of menopause-related books and influencers around Christmas, which increases interest. But she says this can lead some women to believe that hormone replacement therapy is the answer to all medical problems for midlife women.
“There are a lot of these things, and it’s hard to tease out what’s due to menopause and what’s due to aging,” she says. “Metabolic changes occur with age. Hormone replacement therapy is not a magic jelly bean that will make us young again or stop the aging process.”
“My health is worth it”
Physician Heather Hirsch, founder of the menopause clinic at Brigham and Women’s Hospital in Boston, sees about 18 women a day.
There wasn’t enough time to listen to them.
“During perimenopause, women want to talk about endometriosis, periods, childbirth, and even divorce,” say the authors of The Perimenopause Survival Guide. “The trauma of being a woman includes many other things, not just reproductive health.”
Because the symptoms of perimenopause and menopause are so diverse that women often seek advice from a dermatologist for dry skin, a neurologist for brain fog, an obstetrician-gynecologist for vaginal dryness, and a general practitioner for high cholesterol.
Now, she runs The Collaborative, which specializes in concierge services, but sees less than half that number a day.
For Andresen, the concierge model just made sense.
“I went to many doctors and spent a lot of money until I reached my deductible,” she said. “This was really a last resort.”
She liked the personal attention her doctor gave her and said her first appointment took more than an hour. But she also likes the education provided. She watches over eight hours of videos about menopause, rattling off statistics like a doctor.
Now, she’s sharing this valuable, hard-earned knowledge with friends, and even wrote a letter to the FDA this summer proposing better treatments for women.
Her health is worth it.
Laura Trujillo is a national columnist focused on health and wellness. She is the author of “Stepping Back from the Ledge: A Daughter’s Search for Truth and Renewal” and can be reached at ltrujillo@usatoday.com.
