Bharti Jayshankar
December 19, 2024: The U.S. Food and Drug Administration (FDA) has issued a black box warning for Veozah, a medication designed to alleviate menopausal hot flashes, due to serious liver injury risks associated with the drug.
Veozah: A hormone-Free hot flash treatment
Veozah (fezolinetant) was approved by the FDA in May 2023 as the first hormone-free treatment for moderate to severe hot flashes caused by menopause. It operates by blocking neurokinin B receptors in the brain, which play a crucial role in regulating body temperature. This non-hormonal approach has made it a popular choice for women seeking alternatives to traditional hormone replacement therapies.
Liver risks associated with Veozah
The FDA’s black box warning stems from reports of serious liver injuries linked to Veozah. A reported case involved a patient who developed elevated liver enzymes and symptoms such as fatigue, nausea, and jaundice after approximately 40 days of treatment. Following the discontinuation of the drug, the patient’s liver function tests returned to normal.
The FDA now recommends that patients undergo monthly blood tests for liver function during the first three months of treatment and additional tests at six and nine months.
FDA’s decision
The decision to issue a black box warning followed an assessment of postmarketing data, including adverse event reports submitted to the FDA Adverse Event Reporting System (FAERS). This alert reflects the agency’s commitment to patient safety while also emphasizing that the overall benefit-risk profile of Veozah remains favorable.
Weighing risks and benefits
Patients taking Veozah should be vigilant about monitoring their health. Symptoms indicating possible liver injury—such as extreme tiredness, unusual itching, dark urine, or yellowing of the skin—should prompt immediate consultation with a healthcare provider. While Veozah offers a non-hormonal option for managing hot flashes, patients must weigh these benefits against the risks of serious side effects.
More than 80 percent of menopausal women experience sudden, often debilitating hot flashes lasting several minutes that can be accompanied by sweating, flushing, and chills. Traditionally, estrogen-based hormone replacement therapy has been prescribed to help ease these symptoms, but recent studies have linked its usage to heightened risk for breast cancer and stroke. Furthermore, hormone therapies are contraindicated in women with a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease.
Alternative treatments for menopausal hot flashes
For those concerned about the risks associated with Veozah, several alternative treatments are available. These include lifestyle modifications, herbal supplements, cognitive behavioral therapy, and other non-hormonal medications that may help alleviate menopausal symptoms without the same level of risk associated with liver injury. Consulting with healthcare providers can help identify suitable alternatives tailored to individual needs.
The FDA’s black box warning on Veozah serves as a critical reminder for both patients and healthcare providers about the potential risks associated with medications used for menopausal symptom management. By staying informed about these developments and engaging in proactive health monitoring, women can make educated choices regarding their treatment options while navigating the complexities of menopause.
