FDA warns of potential liver injury with Veozah for menopausal hot flashes
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Key takeaways:
- The FDA issued a warning that use of fezolinetant can cause rare but serious liver injury.
- The announcement comes after a report of a patient with signs and symptoms of liver injury.
The FDA issued a warning that use of fezolinetant, a nonhormonal medication indicated for treating menopausal hot flashes, can cause rare but serious liver injury, according to an agency press release.
FDA stated that, if there are signs and symptoms suggesting liver injury, stopping fezolinetant (Veozah, Astellas) could prevent worsening liver injury and potentially return liver function to normal.
The liver injury warning follows an existing FDA warning about elevated liver function test values and required liver function testing in the prescribing information for fezolinetant. The FDA issued the update after reviewing a postmarketing report of a patient with elevated liver function test values and signs and symptoms of liver injury after taking fezolinetant for about 40 days.
“This change in the FDA prescribing recommendations for fezolinetant should not discourage women from using this effective therapy for management of hot flashes,” Stephanie S. Faubion, MD, MBA, NCMP, IF, director of the Mayo Clinic Center for Women’s Health and medical director of The Menopause Society, told Healio after the warning was issued. “This is still a very rare event and is reversible upon discontinuation of the drug.”
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.
As Healio previously reported, the FDA in May 2023 approved fezolinetant for moderate to severe hot flashes due to menopause. Approval was based on results of the SKYLIGHT trials, which demonstrated safety and efficacy of fezolinetant. The medication is not a hormone; fezolinetant binds and blocks activities of the neurokinin 3 receptor, which impacts the brain’s body temperature regulation.
The warning states health care providers should inform patients about the risk for elevated liver blood test values that may occur during treatment and the rare but serious risk for liver injury and advise them of the need for regular liver blood testing.
In a statement provided to Healio, Astellas said FDA identified a probable case of serious drug-induced liver injury that occurred in a woman in the U.S. receiving fezolinetant with symptoms of fatigue, nausea, pruritus, jaundice, pale feces and dark urine. The individual’s abnormalities gradually resolved after discontinuation of the drug, according to the company.
“We are committed to ensuring the hepatic laboratory testing protocol in the Veozah U.S. prescribing information identifies patients at risk for or experiencing symptoms of potential drug induced liver injury as early as possible and therefore have added two additional timepoints for hepatic tests to the label, testing for an additional liver value, as well as guidance on when to seek medical attention and when to discontinue Veozah,” the company told Healio. “Specifically, the updated testing protocol is a baseline test, monthly tests for the first 3 months, at 6 months and 9 months after initiation of therapy and testing for an additional liver value. Patients are advised to discontinue Veozah immediately and seek medical attention including hepatic laboratory tests when signs or symptoms may suggest liver injury, such as new onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or right upper quadrant pain.”