Hot flashes and sleepless nights are just some of the symptoms of perimenopause that have been disrupting Isabel Kallman’s life.
At 53 years old, Kallman’s hormones naturally started to decline, and the only medication available for her is menopause hormone therapy. For women experiencing the lead-up to menopause, hormone therapy treatment can involve using estrogen to help alleviate symptoms — but Kallman said she has been on the fence about it due to so-called “black box” labels on the medication, warning of the risk for stroke, blood clots, dementia and breast cancer.
Kallman told CBS News she has been using “Fanny,” a handheld fan that she keeps in her bag to help with some of her symptoms. But now she’s considering hormone replacement as the Food and Drug Administration weighs removing some of the health warnings for certain treatments.
Dr. Mary Rosser, who has been Kallman’s doctor for five years, said she believes flawed research from more than 20 years ago overstated the risks of breast cancer because it focused on older women.
“It’s been overblown,” Dr. Rosser, the director of Integrated Women’s Health at Columbia University Irving Medical Center/NewYork-Presbyterian, told CBS News.
The 2002 Women’s Health Initiative, the largest long-term study on women’s health at the time, focused on older women who may not have started hormone replacement therapy until 10 or so years after going through menopause.
The study, which raised safety concerns and led to a longtime public misunderstanding around hormone therapy, has since been found problematic in terms of how it was designed, according to Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News. Now, health care professionals say factors such as age and dosing contribute to the safety of the treatment.
More recent studies show that timing of treatment matters — a woman’s age when she begins menopause hormone therapy, along with the delivery method, can substantially mitigate risks, Gounder says.
It’s “an example of [how] science evolves,” Gounder said of recent studies. Hormone therapy is the most effective treatment for a lot of perimenopausal symptoms, according to Gounder, who stressed that patients need to sit down with their doctors to determine what is right for them.
Generally, treatment should start as close to the patient’s final menstrual period and continue until about the age of 60, Dr. Rosser says.
“We have to look at your risk and calculate your risk score,” Dr. Rosser told Kallman.
Dr. Rosser has spent the past nine months working through the benefits and risks with her patient, who has a family history of breast cancer. While Kallman said she’s still hesitant, she realizes hormone therapy may be her best chance at relief.
“I’m hoping that there is an opportunity for me to do it,” Kallman told CBS News, adding that she hopes there’s an option that will help her in the short term.
One type of treatment is low-dose vaginal estrogen therapy. Others include whole-body therapy like pills, patches, sprays, gels or a vaginal ring that deliver doses of hormones into the bloodstream at levels high enough to have significant effects on symptoms such as hot flashes.
As experts like Dr. Rosser continue to have conversations about how to present the treatment’s pros and cons, an FDA-assembled panel has stressed the benefits and suggested health warnings be removed from at least some versions. However, dozens of experts called for more input before making any changes.
A letter signed by 76 doctors and researchers argues that “removing label warnings without adequate scientific assessment puts patients at risk,” The Associated Press reported. The group asked the FDA to hold an advisory committee meeting with a public hearing before making any changes.
Dr. Rosser said she sees it as a step in the right direction.
“This is a public health priority, and this is a sign that the FDA sees that,” she told CBS News.
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