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Menopause Hormone Therapy: Re-evaluating the Risks and Benefits Amidst FDA Review

Monday, September 15, 2025 | 0 Views Last Updated 2025-09-16T04:12:21Z

The debilitating symptoms of perimenopause – hot flashes, sleep disturbances, and more – significantly impact the lives of millions of women. For many, hormone replacement therapy (HRT) offers a potential solution, but lingering concerns about potential risks have created hesitancy. This is particularly true given the historical 'black box' warnings associated with HRT, highlighting risks of stroke, blood clots, dementia, and breast cancer. However, a crucial reassessment is underway as the Food and Drug Administration (FDA) considers removing or altering these warnings.

Menopause Hormone Therapy: Re-evaluating the Risks and Benefits Amidst FDA Review
Image Source: www.cbsnews.com

The FDA's review is prompted by evolving scientific understanding. Studies like the 2002 Women's Health Initiative, while influential in shaping initial perceptions, have since been criticized for methodological limitations, particularly their focus on older women who started HRT significantly after menopause. Current research emphasizes the critical role of timing and dosage. Starting HRT closer to the final menstrual period and continuing until approximately age 60, alongside appropriate dosage, is shown to substantially mitigate potential risks.

Dr. Mary Rosser, director of Integrated Women's Health at Columbia University Irving Medical Center/NewYork-Presbyterian, highlights that older research may have overstated the risks, particularly regarding breast cancer. She emphasizes a personalized approach, carefully evaluating a patient's individual risk factors before recommending HRT. This approach is crucial, as demonstrated by Isabel Kallman's case. At 53, Kallman is navigating the decision, weighing the potential benefits against her family history of breast cancer.

While HRT, including options like low-dose vaginal estrogen therapy and whole-body treatments (pills, patches, sprays, gels, or rings), offers effective relief for many symptoms, a cautious approach remains necessary. Although an FDA panel has suggested removing warnings from some HRT versions, a group of 76 doctors and researchers has called for more rigorous scientific assessment before any changes are implemented, emphasizing the importance of patient safety. This ongoing debate underscores the complexity of the issue and the need for a balanced approach to inform both medical professionals and patients. The ultimate goal is to provide women with accurate information, enabling informed decisions about their health and well-being during this significant life stage.


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Originally published at: https://www.cbsnews.com/news/hrt-for-menopause-risks-benefits-fda-black-box-warnings/

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