Drug approvals & safety alerts
A dated feed of the FDA approvals, safety warnings, and labeling changes that matter most for menopause, hormone, thyroid, and women's health — each with the official source and, where we have it, our plain-language explainer.
- Labeling change
FDA moves to remove the boxed warning from menopausal hormone therapy
U.S. health officials announced the FDA would begin removing the prominent “boxed” warning from menopausal hormone therapy products, dropping blanket statements about heart disease, breast cancer, and dementia risk. The change updates the labeling to reflect current evidence; it is not a statement that hormone therapy is risk-free.
- Approval
FDA approves fezolinetant (Veozah), a non-hormonal drug for hot flashes
The FDA approved fezolinetant, the first neurokinin-3 (NK3) receptor antagonist for moderate-to-severe hot flashes due to menopause — a non-hormonal option for women who cannot or prefer not to use hormones.
- Safety
FDA adds a warning about rare serious liver injury with Veozah (fezolinetant)
The FDA added a warning that fezolinetant can rarely cause serious liver injury, and advised liver-function testing before and during treatment. It remains an option, with monitoring, for suitable candidates.
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