HEALTH

FDA Eases Warnings on Menopause Hormone Treatments

USA, WashingtonTue Nov 11 2025
The FDA has decided to take off the strong warning labels from hormone-based menopause treatments. These treatments help with hot flashes and night sweats. The warning labels talked about serious risks like stroke, heart attacks, and dementia. This change is based on new studies. They show that hormone therapy is safer when started before age 60 and within 10 years of menopause. Some doctors support this change. They say the old warning was outdated and scared women away from treatments that could help them. But not everyone agrees. Some experts think the FDA should have been more careful. They wanted a public review process. They say the FDA should have talked to independent advisers before making this decision. The original warning came from a big study over 20 years ago. It linked hormone pills to higher risks of stroke, blood clots, and breast cancer. After this study, many women stopped using these treatments. But newer research shows a different picture. It suggests that younger women may not face the same risks. Now, the warning information will be moved to a less prominent place on the label. This change could help doctors and patients make better choices. It might also encourage more personalized treatment plans. Some doctors believe hormone therapy can do more than just ease menopause symptoms. They say it might also reduce the risk of heart disease and Alzheimer's. But other experts are not so sure. They say the evidence is not strong enough to make big claims. The FDA's decision was made without a formal public meeting. Instead, a small group of doctors and researchers was invited to discuss the issue. Many of these experts support hormone therapy. Some even work with drug companies that make these treatments. Critics say this process was not transparent. They think the FDA should have involved more scientists and held a public meeting. They worry that this could hurt the FDA's credibility.

questions

    Are the studies supporting the benefits of hormone therapy being manipulated to favor certain political or economic interests?
    What are the long-term effects of hormone therapy on women who start treatment after age 60?
    What are the potential biases in the studies that led to the removal of the warning label, and how do they affect the conclusions?

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