Patients should stop taking Veozah immediately and contact the doctor who prescribed the medicine if they experience signs and symptoms that suggest liver problems, USFDA recommended.
The U.S. Food and Drug Administration (FDA) on Friday issued a warning that Veozah (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, the US regulatory body explained.
“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,” FDA said in a statement.
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, it stated.
“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 added.
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What is Veozah (fezolinetant)?
Veozah (fezolinetant) is a nonhormonal prescription medicine approved in May 2023 to reduce the frequency and severity of moderate to severe hot flashes caused by menopause. According to FDA, the medicine is in a drug class called neurokinin 3 (NK3) receptor antagonists. It works to restore the balance between estrogen hormones and a brain chemical called neurokinin B (NKB) by blocking the activities of the NK3 receptor, which plays a role in the brain’s control of body temperature.
Veozah works to restore the balance between estrogen hormones and a brain chemical called neurokinin B (NKB) by blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature. Veozah is available as a tablet taken by mouth once daily.
“Common side effects include stomach pain, diarrhea, difficulty sleeping, back pain, hot flashes, or hot flushes. Veozah use in the U.S. has steadily increased since approval in May 2023. In May 2024, an estimated 28,700 patients were dispensed Veozah from U.S. outpatient retail pharmacies,” it added.
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What should patients and caregivers do?
Patients should stop taking Veozah immediately and contact the health care professional who prescribed the medicine if they 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. Your healthcare professional will do blood tests before starting Veozah and during treatment to check and monitor how well your liver is working,” it added.
Talk to your healthcare professional about the risks and benefits of taking Veozah and discuss any questions or concerns you may have, including about possible alternative treatments, FDA recommended.
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What should doctors do?
The US body recommended that healthcare 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,” the FDA said.
What did FDA find?
The USFDA reviewed a post marketing 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, FDA found.
“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 (fezolinetant),” the US body emphasised.
Meanwhile, the regulator also informed that to help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving Veozah (fezolinetant) or other medicines to the FDA MedWatch program.
