FDA Adds Warning to Veozah Menopause Drug

On September 12, the U.S. Food and Drug Administration announced a new warning for Veozah, a medication prescribed for managing hot flashes associated with menopause. This decision followed a case where a patient experienced severe liver injury, marked by symptoms such as jaundice and dark urine, within 40 days of initiating treatment. Fortunately, these symptoms resolved after discontinuation of the drug, and subsequent blood tests indicated a return to normal liver function. The FDA emphasized the importance of monitoring for potential liver damage, advising patients to cease use of Veozah if they notice any signs of liver injury. Symptoms to watch for include fatigue, nausea, jaundice, dark urine, and abdominal pain. Patients experiencing these symptoms are urged to consult their healthcare provider for appropriate blood tests and evaluations. In addition to the liver-related risks, the FDA noted that all medications can have side effects, which may vary based on individual health conditions, genetic factors, and concurrent medications. As a precaution, the FDA had previously recommended that patients undergo liver function tests before starting Veozah and continue testing every three months for the first nine months of treatment. Astellas Pharma Inc., the distributor of Veozah in the U.S., has not commented on the FDA's announcement. This development highlights the necessity for ongoing vigilance regarding the safety of medications, particularly those prescribed for managing menopausal symptoms.