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FDA Drops Black Box Warnings on Menopause Treatments, Citing Outdated Data
12 Nov
Summary
- FDA eliminates black box warnings on hormone replacement therapy (HRT) medications
- Warnings were based on outdated data, discouraging women from beneficial treatment
- Recent studies show current HRT formulations do not have same increased risks
On November 12, 2025, the U.S. Food and Drug Administration (FDA) announced a major shift in how hormone replacement therapy (HRT) is viewed for menopausal women. The agency is eliminating the prominent "black box" warnings that have appeared on HRT medication packaging for over two decades.
The decision affects products containing estrogen or progestogen, alone or combined, that are prescribed to treat troublesome menopause symptoms like hot flashes, mood swings, and sleep difficulties, as well as to reduce bone fractures. FDA officials stated the warnings were based on outdated scientific data that has discouraged many women from receiving beneficial treatment.
The "black box" warnings were mandated after a 2002 clinical trial pointed to an increased risk of breast cancer, heart attack, and stroke in women using HRT. However, doctors have long argued that the trial was flawed, as it primarily looked at women in their 60s and 70s and used a specific hormone formulation not widely prescribed today. Recent studies using current HRT formulations have not found the same increased risk of adverse events.
The FDA is now recommending that women who are considering systemic HRT (pills or patches) should start treatment before age 60 or within 10 years of the onset of menopause, as early use may offer benefits like reduced risk of cognitive decline and cardiovascular disease. However, the agency noted that the decision to use HRT is between patient and doctor and not a universal solution, as alternatives such as cognitive therapy or non-hormonal medications are also available.
