FDA again bypasses advisers to remove black-box warnings from menopause treatments

The US FDA has removed black-box warnings regarding breast cancer, cardiovascular disease, and dementia from three additional menopause estrogen patches. This follows similar removals for six treatments in February. Some experts have raised concerns over a lack of transparency, as the FDA did not convene an advisory committee or provide detailed scientific justifications during the briefing. These regulatory changes occur while patients across the US continue to face significant shortages of these essential menopause patches.