FDA Lifts 'Black Box' Warnings on Menopause Hormone Therapy, Citing Updated Science and Efficacy
The FDA is removing 'black box' warnings from menopause hormone therapies, citing updated science and effectiveness. This corrects previous misinterpreted data that discouraged millions of women.
Overview
- The FDA has officially announced the removal of 'black box' warning labels from hormone replacement therapy products, including estrogen-containing drugs, used to alleviate menopause symptoms.
- These stringent warnings were originally based on misinterpreted data and outdated scientific understanding, which unfortunately led to millions of women avoiding beneficial hormone replacement therapy.
- The decision reflects current understanding that hormone replacement therapy effectively treats menopausal symptoms and may offer long-term health benefits, prompting this significant regulatory change.
- The warnings previously highlighted serious risks such as breast cancer, heart attack, stroke, and dementia, which are now being re-evaluated in light of new evidence.
- The FDA now recommends hormone therapy for women under 60 or within 10 years of menopause onset, as studies indicate a low risk profile for this specific demographic.
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Analysis
Center-leaning sources largely frame the FDA's decision to remove the black box warning on hormone therapy as a positive, long-overdue correction. They emphasize the benefits for women and the outdated nature of previous warnings, often downplaying or omitting criticisms regarding the decision-making process or ongoing scientific debate.
"The FDA is taking action to remove the black box warnings from estrogen-related products."
NBC News"The removal of the warning label will change the way prescribers treat women in menopause."
USA TODAY"The Food and Drug Administration announced Monday that hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia and other serious risks."
Associated PressArticles (7)
FAQ
The original 'black box' warnings were based on a Women’s Health Initiative study that found a statistically non-significant increase in breast cancer risk. However, the study participants were older (average age 63) and used hormone formulations no longer in common use, leading to misinterpretation of risks for younger menopausal women.
The removal means that women, especially those under 60 or within 10 years of menopause onset, can now consider hormone replacement therapy with a better understanding of its risks and benefits, as current evidence shows a low risk profile for this group.
Yes, the FDA is not removing the 'black box' warning for endometrial cancer for systemic estrogen-alone products. Other risks are being re-evaluated and updated in product labeling.
The FDA conducted a comprehensive review of scientific literature, convened an expert panel in July, and held a public comment period before deciding to remove the broad 'black box' warnings.
Hormone replacement therapy can effectively relieve menopausal symptoms such as hot flashes, night sweats, and mood changes, and may offer long-term health benefits for women under 60 or within 10 years of menopause onset.
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