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Fezolinetant (VEOZAH) is approved for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause.[1] In December 2024 the Food and Drug Administration (FDA) added a boxed warning — the agency’s most prominent warning — to the drug’s prescribing information about the risk of serious liver injury (known as hepatotoxicity).[2]
As discussed in the May 2024 issue of Worst Pills, Best Pills News,[3] the FDA first approved fezolinetant in 2023; it is the second...
Fezolinetant (VEOZAH) is approved for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause.[1] In December 2024 the Food and Drug Administration (FDA) added a boxed warning — the agency’s most prominent warning — to the drug’s prescribing information about the risk of serious liver injury (known as hepatotoxicity).[2]
As discussed in the May 2024 issue of Worst Pills, Best Pills News,[3] the FDA first approved fezolinetant in 2023; it is the second nonhormonal drug approved for the treatment of hot flashes. Fezolinetant is taken orally as a 45-milligram tablet once a day. Unlike hormonal treatment, the drug is approved only for hot flashes, not any of the other symptoms of menopause. Public Citizen’s Health Research Group designated fezolinetant as a Do Not Use drug because its limited benefits do not outweigh the safety concerns that were known at the time of approval, such as abdominal pain, diarrhea, insomnia, and elevated blood levels of a liver enzyme known as hepatic transaminase.
The FDA recommends that anyone taking fezolinetant who experiences symptoms of liver injury should immediately stop taking the drug and contact their clinician.[4] Typical symptoms of liver injury include feeling unusually tired, vomiting, nausea, light-colored stools, unusual itching, jaundice (yellowing of the eyes or skin), dark urine, and swelling or pain in the abdomen. The agency recommends testing before treatment begins, increasing the frequency of liver blood testing to monthly tests in the first three months of treatment, and then testing again at six and nine months. If the values of certain liver blood tests are too high, the drug either should not be started or should be stopped immediately.
The boxed warning follows a safety communication that the FDA issued in September 2024 and adds to a general warning about elevated values of liver blood tests that was already included in the prescribing information.[5],[6] The new warning became necessary because post-marketing evidence showed that a patient with normal liver blood test values prior to treatment developed elevated liver blood test values and symptoms of serious liver injury within 40 days of starting fezolinetant. After the drug was stopped, symptoms of liver injury decreased and the liver blood test values returned to normal.
References
[1] Astellas Pharma US. Label: fezolinetant (VEOZAH). December 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216578s004lbl.pdf. Accessed February 4, 2025.
[2] Food and Drug Administration. FDA adds warning about rare occurrence of serious liver injury with use of Veozah (Fezolinetant) for hot flashes due to menopause. December 20, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due. Accessed February 4, 2025.
[3] Do not use fezolinetant (VEOZAH) for the treatment of hot flashes (vasomotor symptoms). May 2024. Worst Pills, Best Pills News. https://www.worstpills.org/newsletters/view/1595. Accessed February 4, 2025.
[4] Food and Drug Administration. FDA adds warning about rare occurrence of serious liver injury with use of Veozah (Fezolinetant) for hot flashes due to menopause. December 20, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due. Accessed February 4, 2025.
[5] FDA issues warning about rate but serious liver injury with the use of fezolinetant (VEOZAH) for hot flashes due to menopause. Worst Pills, Best Pills E-alert. September 16, 2024. https://www.worstpills.org/e-alerts/view/146. Accessed February 4, 2025.
[6] Food and Drug Administration. FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause. December 20, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due. Accessed February 4, 2025.
