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  5. FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause
  1. FDA Drug Safety Podcasts

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause

FDA Drug Safety Podcast

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On September 12, 2024, the FDA is warning that Veozah (active ingredient fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury and potentially return liver function to normal.

We added a warning about the risk of liver injury to the existing warning about elevated liver blood test values and required liver blood testing in the prescribing information for Veozah. We made this update after reviewing a postmarketing report of a patient with elevated liver blood test values and signs and symptoms of liver injury after taking the medicine for about 40 days. We also added new recommendations for patients and health care professionals about increasing the frequency of liver blood 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.

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. When prescribing Veozah, inform patients about the risk of elevated liver blood test values that may occur during treatment and the rare but serious risk of liver injury, and advise them of the need for regular liver blood testing. Discuss the signs and symptoms of liver injury and instruct patients to stop Veozah immediately and contact the health care professional who prescribed the medicine if they develop these any time during treatment.

We reviewed a postmarketing case of serious liver injury in a patient who experienced symptoms of fatigue, nausea, itching, yellow eyes and skin, light-colored stools, and dark urine within 40 days of starting Veozah. The patient’s liver blood test values were elevated, including abnormal liver enzymes and bilirubin levels. After stopping the medicine, the patient’s symptoms gradually went away, and blood test values slowly returned to normal.

All medicines have side effects even when used correctly as prescribed. It is important to know that people respond differently to all medicines depending on their health, the diseases they have, genetic factors, other medicines they are taking, and many other factors. As a result, we cannot determine how likely it is that someone will experience these side effects when taking Veozah. Your health care professionals know you best, so talk to them if you have questions or concerns about risks of taking Veozah.

Side effects involving Veozah should be reported to FDA’s MedWatch reporting program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found  at www.fda.gov/drugsafetycommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov. And follow us on X @FDA_Drug_Info for up to the minute important drug information.

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