FDA again bypasses advisers to remove black-box warnings from menopause treatments
Summary
The FDA said it will remove black-box warnings about cardiovascular disease, breast cancer and dementia from three more menopause-treatment patches. The agency did not convene an advisory committee or present the scientific evidence for its decision at a press briefing, drawing concerns from a researcher about transparency and patient safety.Key Facts
- The FDA previously removed black-box warnings from six menopause treatments in February.
- FDA officials said the agency is working with manufacturers to increase supply of menopause hormone treatments.
- A federal health official said estrogen patch manufacturing had doubled over the past year.
- FDA officials said demand for estradiol patches rose significantly after the February label changes, and patients in many areas had trouble finding them.
- The FDA said it is working to change labels for other menopause hormone therapy products.
- An FDA official said updated evidence points to a different risk-benefit profile for many healthy women under 60 and within 10 years of menopause onset than earlier warnings conveyed.
- The FDA is exploring whether vaginal estrogen products could be sold over the counter.
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