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Evaluating the advantages and dangers of hormone therapy for menopause as FDA thinks about lifting “black box” warnings

Evaluating the advantages and dangers of hormone therapy for menopause as FDA thinks about lifting "black box" warnings

Considering Hormone Therapy Amid Perimenopause Symptoms

Isabel Kallman, at 53, is grappling with the challenges of perimenopause, like hot flashes and restless nights. As her hormone levels begin to decline, she finds that the only option currently available to her is hormone therapy. This treatment typically includes estrogen, aimed at easing those bothersome symptoms. However, Kallman has reservations—primarily due to the “black box” warnings associated with such medications that highlight risks like stroke, blood clots, dementia, and breast cancer.

In a conversation with CBS News, Kallman mentioned using “Fanny,” a small handheld fan she carries, as a way to cope. But recent discussions about the FDA potentially lifting some health warnings related to certain treatments have prompted her to reconsider hormone replacement therapy.

Dr. Mary Rosser, Kallman’s physician for the past five years, expressed her belief that outdated research conducted over two decades ago has exaggerated the risks associated with hormone therapy. She noted that this early research primarily involved older women who were not starting hormone therapy until years after menopause.

“It’s been overblown,” Dr. Rosser, who leads the Integrated Women’s Health program at Columbia University, told CBS News.

The 2002 Women’s Health Initiative, a significant long-term study on women’s health, primarily focused on older women who may have missed the optimal age for initiating hormone therapy. Concerns raised by this study have contributed to long-lasting misconceptions about hormone therapy, according to CBS News medical contributor Dr. Céline Gounder. She points out that more recent insights suggest age and dosage are critical factors in assessing the safety of hormone treatments.

Newer research indicates that the timing of hormone therapy is crucial—starting at the right age and considering the method of delivery can significantly reduce risks. Gounder sees this as a positive shift in understanding the subject. She describes hormone therapy as a key treatment for many symptoms associated with perimenopause and emphasizes the importance of open discussions between patients and their doctors to evaluate individual needs.

Dr. Rosser generally recommends that treatment begin close to when menstruation ceases, ideally continuing until around age 60. “We have to look at your risk and calculate your risk score,” she advised Kallman.

In the past nine months, Dr. Rosser and Kallman have been discussing the potential benefits and risks of hormone therapy, especially considering Kallman’s family history of breast cancer. Although Kallman remains cautious, she understands that hormone therapy might be her best option for relief. “I’m hoping that there is an opportunity for me to do it,” she shared, expressing a desire for a short-term solution to her symptoms.

Low-dose vaginal estrogen therapy is one option available, among other treatments like pills, patches, sprays, gels, or vaginal rings designed to deliver the hormones effectively into the bloodstream, targeting symptoms like hot flashes.

As experts like Dr. Rosser deliberate on how to convey the pros and cons of these treatments, an FDA panel has recognized the positive effects and proposed revising some of the associated health warnings. Nevertheless, a group of 76 doctors and researchers has urged caution, warning that removing such warnings without thorough scientific evaluation could jeopardize patient safety. They have requested that the FDA conduct an advisory committee meeting with public input before any changes are made.

Dr. Rosser views this ongoing dialogue as a promising step forward. “This is a public health priority, and this is a sign that the FDA sees that,” she conveyed to CBS News.

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