FDA to Strip Black‑Box Warnings From Menopause Hormone Therapy Drugs, Citing Decline in Use
The U.S. Food and Drug Administration announced that it will remove the black‑box warning labels from a majority of hormone‑therapy products prescribed for menopause and perimenopause symptoms. The agency’s director described the previous labeling as having contributed to a sharp drop in usage, calling the situation an "American tragedy" that left many women without effective symptom relief.
The black‑box warnings were first added in the early 2000s after large clinical studies suggested elevated risks of cardiovascular events, stroke, and certain cancers among women taking combined estrogen‑progestin therapy. Those warnings prompted a rapid decline in prescriptions, and many clinicians shifted toward non‑hormonal alternatives despite limited efficacy for severe vasomotor symptoms.
More recent research, including updated meta‑analyses and longer‑term follow‑up studies, has indicated that the risks are largely confined to specific sub‑populations and dosing regimens. FDA officials said the new evidence supports a more nuanced risk‑benefit assessment, particularly for younger post‑menopausal women and those without a history of cardiovascular disease. The agency plans to retain standard prescribing information while eliminating the most severe warning label.
Health experts have welcomed the move as a step toward aligning regulatory language with current science, though they emphasize the need for continued physician vigilance. Patient‑advocacy groups praised the decision, noting that many women had discontinued therapy despite persistent, debilitating symptoms. The FDA indicated that it will monitor post‑removal outcomes closely and that manufacturers are required to update labeling to reflect the revised safety profile. The change is expected to broaden treatment options and may reverse the decline in hormone‑therapy use over the coming years.
