FDA Adds Black Box Warning to Fezolinetant Label, Advising of Rare but Serious Liver Injury
The FDA added a boxed warning for rare but serious liver injury to fezolinetant (Veozah) labeling, emphasizing hepatotoxicity and increased LFT testing. A postmarketing report detailed a patient's severe hepatic injury, resolved after treatment cessation. Fezolinetant, approved in May 2023 as the first non-hormonal VMS treatment, restores neurokinin B balance disrupted by menopause. The updated prescribing info includes monthly LFT testing for 2 months post-initiation, then at 3, 6, and 9 months, with immediate discontinuation upon liver injury symptoms.
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The FDA added a boxed warning for rare but serious liver injury to fezolinetant (Veozah) labeling, emphasizing hepatotoxicity and increased LFT testing. A postmarketing report detailed a patient's severe hepatic injury, resolved after treatment cessation. Fezolinetant, approved in May 2023 as the first non-hormonal VMS treatment, restores neurokinin B balance disrupted by menopause. The updated prescribing info includes monthly LFT testing for 2 months post-initiation, then at 3, 6, and 9 months, with immediate discontinuation upon liver injury symptoms.