FDA adds boxed warning to hot flash drug Veozah due to liver injury risk
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Key takeaways:
- The FDA added a boxed warning to fezolinetant to highlight the known risk for rare but serious liver injury.
- Health care professionals should measure liver blood values before prescribing the hot flash drug.
The FDA added a boxed warning to highlight known risk for rare but serious liver injury associated with the use of fezolinetant, a nonhormonal medication indicated for treating menopausal hot flashes, according to an agency press release.
The boxed warning, the FDA’s most prominent warning, follows a notice the agency issued in September stating fezolinetant (Veozah, Astellas) can cause rare but serious liver injury and elevated liver function test values. The FDA issued the earlier 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. At that time, 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 fezolinetant and then at months 3, 6, and 9 of treatment as already recommended.
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 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 noted that 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 warning also includes 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 fezolinetant, and then at months 3, 6, and 9 of treatment as already recommended.