SAN ANTONIO – An announcement earlier this month from the U.S. Department of Health and Human Services will change the lives of millions of American women.
After decades, the U.S. Food and Drug Administration (FDA) will remove the so-called black box warning from all hormone replacement medicines containing estrogen.
Hormone replacement therapy, or HRT, helps relieve menopause and perimenopause symptoms, including but not limited to:
- Hot flashes
- Night sweats
- Mood swings
- Depression
- Anxiety
- Insomnia
- Irritability
- Headaches
- Muscle joint pain
- Decreased libido
- Palpitations
- Fatigue
- Dry skin
- Weight gain
A 2002 study, now irrelevant, linked estrogen therapy to breast cancer, heart disease, and dementia. The study caused fear, and many doctors stopped prescribing the treatment, and many women stopped taking it.
San Antonio mom Bonnie Tompsett remembers when the warnings came out decades ago.
“I remember thinking, ‘Oh gosh, you know, that’s scary and I can’t believe like all these people are on it and there’s this warning,’” Tompsett said.
She said she began to experience menopause symptoms a little under two years ago.
“The hot flashes, the regular sleep patterns, some other kind of weird things, just not thinking clearly,” Tompsett said, expressing that the symptoms were derailing her life.
Tompsett’s doctor prescribed her hormone replacement therapy in the form of progesterone pills and estrogen gel.
While the black box warning was only for estrogen products, women who still have a uterus also need to take progesterone with the estrogen.
After taking the hormone therapy, Tompsett said she felt better almost immediately.
“I even feel better than I did like eight years ago,” she said. “Like the hot flashes were gone for sure within a week. Some of the other stuff, a few more weeks.”
When she began taking it, the warning was still in place, but more people across the country were calling for its removal.
The FDA now agrees with those requests, saying the warning was based on a flawed study.
“A Women’s Health Initiative study that found a statistically non-significant increase in the risk of breast cancer diagnosis,” the FDA said in its announcement of the warning removal. “The average age of women in the study was 63 years — over a decade past the average age of a woman experiencing menopause — and study participants were given a hormone formulation no longer in common use.”
The FDA and HHS report that newer, more accurate studies involving almost 27,000 women found that hormone replacement therapy does not increase the risk of cancer. In fact, women who start the treatment before the age of 60 appear to have a decreased risk.
“It can also decrease the risk for osteoporosis, lower the risk for heart disease,” said University Health Family Nurse Practitioner Jamie Cano-Gomez. “There’s some studies showing that it improves cognitive function that could be related to Alzheimer’s and dementia.”
Cano-Gomez said she was thrilled about the FDA announcement on Nov. 10.
“I was so excited when I saw that. The black box has been lifted. It’s just a huge stepping stone for women’s health,” Cano-Gomez said.
She already has patients calling to ask about it.
“HRT can come in pills, patches, it can come in vaginal rings, it can come in vaginal creams. There are lots of options,” Cano-Gomez said.
However, Cano-Gomez and Tompsett know that damage control is still necessary.
For decades, some doctors have been scared to prescribe the treatment, and many women have been scared to take it, even though it works.
When asked if Tompsett still feels there is fear surrounding the therapy, she said, “Oh yes. I definitely can sense that in people I talk to. I hope it just reassures more women going through it that it’s OK to try it and see if it makes a difference and not to be so fearful.”
She said she hopes it will change the lives of others like it did hers.
Cano-Gomez advises women interested in hormone replacement therapy to talk with their doctor. She said that, even though it’s proven to work for many women, some people shouldn’t use it.
“For some women, that can be hormone-sensitive cancers, if you’ve had a history of a blood clot or something called deep vein thrombosis, history of a stroke, some kinds of liver disease. Those women cannot do hormone replacement, but there’s still other options,” Cano-Gomez said.
There is also hope for more affordable options.
The FDA also announced it is approving two new drugs to expand treatment options for menopausal symptoms.
The first is the approval of a generic version of Premarin, a commonly used hormone replacement therapy.
“The generic product is expected to improve affordability and access while maintaining the same quality, safety, and effectiveness as the brand-name drug,” the FDA said.
The second approval is for a non-hormonal treatment for moderate to severe vasomotor symptoms, such as hot flashes, associated with menopause.
The FDA said that it is an option that provides relief for women who cannot or choose not to use hormone therapy.
Read also: