For more than 20 years, women have seen scary “black box” warnings on hormone replacement therapy: breast cancer, heart attack, stroke, dementia.
Many women in Queens, NY told us, “I’d love help for hot flashes, insomnia, and brain fog… but I’m afraid of hormones.”
That landscape just changed.
In November 2025, the U.S. Department of Health and Human Services (HHS) and the FDA announced they are removing the broad black box warnings from HRT products used for menopause, after a full review of the science and an expert panel earlier this year.
In this article, we’ll break down—in plain language:
Why those warnings were put on HRT in the first place
What the FDA has officially changed (and what it hasn’t)
What up-to-date research actually says about risk
How this affects women considering hormone therapy at Leva Medical in Elmhurst, Queens