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Weighing the benefits and risks of hormone therapy for menopause as FDA considers removing “black box” warnings

CBS News – 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.

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“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.

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It’s “an example of [how] science evolves,” Gounder said of recent studies …

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