FDA issues alert about Astellas’ hot flash drug, says can cause serious liver injury
FDA issues alert about Astellas’ hot flash drug, says can cause serious liver injury
Yesterday the FDA issued an alert about Astellas’ Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, stating that it can cause rare but serious liver injury. The agency stated that if there are signs and symptoms suggesting liver injury, halting use of the medicine could prevent worsening liver injury and potentially return liver function to normal.
The FDA added a warning about the risk of liver injury to the existing warning about elevated liver blood test values and required liver function testing in the prescribing information for Veozah. The agency made this update after reviewing a post marketing report of a patient with elevated liver function test values and signs and symptoms of liver injury after taking the medicine for about 40 days. The FDA also added new recommendations for patients and health care professionals about increasing the frequency of liver function testing, adding monthly testing for the next 2 months after starting Veozah, and then at months 3, 6, and 9 of treatment as already recommended. The updated prescribing information also instructs patients to stop the medicine immediately and contact the health care professional who prescribed the medicine if signs and symptoms of liver injury occur.”
FDA issued the following advice to patients: “Patients should stop taking Veozah immediately and contact your health care professional who prescribed the medicine if you experience signs and symptoms that suggest liver problems. These include feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing of the eyes or skin, called jaundice; dark urine; swelling in the stomach or belly area, called the abdomen; or pain in the right upper abdomen.”
FDA issued the following recommendation to HCPs: “Health care professionals should conduct hepatic laboratory testing before prescribing Veozah, then every month for the first three months after patients start treatment, and then at months 6 and 9 of treatment.”
