FDA Issues Black Box Warning for Menopause Drug Veozah Over Rare Liver Risks

The U.S. Food and Drug Administration (FDA) has placed a black box warning—the most serious safety alert—on Veozah, a drug introduced in 2023 to treat menopausal hot flashes without hormones. The warning highlights a rare risk of severe liver injury. Veozah’s use has grown steadily since its approval, offering relief from vasomotor symptoms that many menopausal women experience. However, the FDA now recommends patients on the medication undergo blood tests to detect liver issues. Symptoms like fatigue, abdominal pain, swelling, nausea, or vomiting should prompt immediate discontinuation of the drug and a consultation with a healthcare provider. Dr. Tamika Augusti, Chair of Women’s and Infants Services at MedStar Washington Hospital Center, emphasized the importance of patient awareness and timely action. Meanwhile, Veozah's manufacturer, Astellas, reaffirmed its commitment to patient safety and educating users about the potential risks. For those experiencing hot flashes, several alternatives to Veozah remain, including lifestyle changes, stress management, dietary adjustments, and even hypnosis. Dr. Augusti advises patients to engage in shared decision-making with their doctors to determine the best treatment plan. If you’re using Veozah or exploring treatment options, consult your healthcare provider for personalized guidance.