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September 16, 2024
On Sept. 12, 2024, the Food and Drug Administration (FDA) issued a safety warning[1] for people taking the oral drug fezolinetant (VEOZAH)[2] for the treatment of hot flashes due to menopause because this drug can cause rare but serious liver injury. The FDA recommended that anyone taking this drug who experiences symptoms of liver injury — such as 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 — should immediately stop taking the drug and contact their clinician.
Approved in May 2023, fezolinetant is a nonhormonal drug for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause.[3] Fezolinetant is a neurokinin 3 receptor antagonist; it blocks a receptor in the brain that plays a role in how body temperature is regulated. Unlike hormone therapy for vasomotor symptoms, fezolinetant is approved only for the treatment of hot flashes, not any of the other symptoms of menopause. It is taken orally as a 45-milligram (mg) tablet once a day. As of May 2024, an estimated 28,700 patients were dispensed fezolinetant from U.S. outpatient retail pharmacies, according to the FDA safety communication.
In the May 2024 issue of Worst Pills, Best Pills News,[4] Public Citizen’s Health Research Group designated fezolinetant as a Do Not Use drug because its limited benefits for vasomotor symptoms did not outweigh the safety concerns that were already known, such as abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated values on liver blood tests.[5]
The new FDA warning adds to a general warning about elevated blood levels of a liver enzyme known as hepatic transaminase, which was included in the prescribing information when the drug was approved. At the time, the FDA required blood tests to evaluate patients’ liver function prior to starting the medication and at three, six and nine months of treatment. Now the FDA is requiring monthly blood tests in the first three months of treatment and then at six and nine months of treatment. If certain liver blood test levels are a specified amount or higher than the upper limit of normal value for the test, the drug should either not be started or should be stopped immediately.
The new warning is based on a post-marketing case that was reported to the FDA Adverse Event Reporting System database. According to the FDA, a patient with normal liver blood test values prior to treatment had elevated liver blood test values and experienced symptoms of serious liver injury within 40 days of starting fezolinetant.[6] After the drug was stopped, the patient’s symptoms gradually went away, and the abnormal liver blood test values returned to normal.
Public Citizen’s Health Research Group recommends that you do not use fezolinetant for the treatment of vasomotor symptoms due to menopause. If you are already taking this drug, make sure that you receive the follow-up liver blood tests for the first three months of treatment, and then again at six and nine months of treatment, and that your clinician has informed you of the signs and symptoms of liver injury. If you experience signs and symptoms that may indicate liver problems, stop taking fezolinetant immediately and contact your clinician.
To see the FDA’s alert, visit the following link: https://www.fda.gov/media/181764/download?attachment.
To read our recent review of fezolinetant (VEOZAH) for the treatment of hot flashes (vasomotor symptoms), visit the following link: https://www.worstpills.org/newsletters/view/1595.
Report any adverse events associated with fezolinetant (VEOZAH) to the FDA’s MedWatch program by calling 1-888-463-6332 or going to https://www.fda.gov/MedWatch.
References
[1] 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. September 12, 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 September 12, 2024.
[2] Astellas Pharma US. Label: fezolinetant (VEOZAH). August 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216578s003lbl.pdf. Accessed September 12, 2024.
[3] Food and Drug Administration. FDA approves novel drug to treat moderate to severe hot flashes caused by menopause. May 12, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause. Accessed September 12, 2024.
[4] 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 September 12, 2024.
[5] Astellas Pharma US. Label: fezolinetant (VEOZAH). August 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216578s003lbl.pdf. Accessed September 12, 2024.
[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. September 12, 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 September 12, 2024.
