FDA Issues Liver Injury Warning for Fezolinetant (Veozah) Used to Treat Menopausal Hot Flashes

Key Insights

• The FDA has issued a warning regarding the use of fezolinetant (Veozah) due to rare but serious liver injury reported in a patient.
• Fezolinetant received FDA approval in May 2023 as a nonhormonal treatment option for managing menopausal hot flashes.
• Despite the warning, experts emphasize that liver injury is rare and reversible upon discontinuation, advising women not to be discouraged from using this effective therapy.

The FDA has issued a warning concerning the use of fezolinetant, marketed as Veozah, a nonhormonal medication prescribed for the treatment of menopausal hot flashes, following a report of a patient experiencing signs and symptoms indicative of liver injury. The agency's announcement highlights a potential risk associated with the drug, which was initially approved in May 2023.

Stephanie S. Faubion, MD, MBA, NCMP, IF, director of the Mayo Clinic Center for Women’s Health and medical director of The Menopause Society, commented on the FDA's warning, stating, “This change in the FDA prescribing recommendations for fezolinetant should not discourage women from using this effective therapy for management of hot flashes. This is still a very rare event and is reversible upon discontinuation of the drug.”

The FDA's action follows a recent study suggesting tampons sold in the U.S. tested for the presence of toxic metals, the FDA announced it has commissioned an independent literature review and internal bench laboratory study to evaluate metals in tampons.