FDA Updates Veozah Label with Warning for Rare but Serious Liver Injury
Key Insights
The FDA has issued a warning for Veozah (fezolinetant) regarding rare but serious liver injury (search) in patients using the drug for hot flashes due to menopause (search).
The updated label includes recommendations for increased frequency of liver blood testing during treatment, specifically monthly for the first two months.
Patients are advised to immediately stop Veozah and contact their healthcare provider if they experience signs and symptoms of liver injury (search).
The FDA has updated the label for Astellas Pharma's Veozah (fezolinetant) to include a warning about the risk of rare but serious liver injury (search). Veozah is a non-hormonal medication approved for the treatment of moderate to severe hot flashes associated with menopause (search). The decision follows a postmarketing review of a patient who developed elevated liver blood test values and signs of liver injury after taking Veozah for about 40 days.
Updated Monitoring Guidelines
The updated prescribing information now advises healthcare professionals to conduct more frequent liver blood tests. This includes monthly screenings for the first two months after initiating Veozah, followed by tests at three, six, and nine months. Baseline hepatic testing before starting Veozah remains a requirement. The FDA emphasizes that patients should immediately discontinue Veozah and contact their healthcare provider if they experience symptoms indicative of liver problems, such as fatigue, nausea, vomiting, unusual itching, jaundice, or dark urine.
Clinical Context and Mechanism of Action
Veozah, approved in May 2023, is a neurokinin 3 (NK3) receptor antagonist. It works by blocking the activity of the NK3 receptor (search), which plays a role in the brain's regulation of body temperature, thereby reducing the frequency and severity of hot flashes. The drug has steadily increased in usage since its approval, with an estimated 28,700 patients receiving Veozah from U.S. outpatient retail pharmacies as of May 2024.
Industry Impact
Despite the new warning, analysts at Jeffries suggest that the updated label may not significantly impact overall demand for Veozah. They noted that while the additional testing requirements will increase the burden on patients, the strengthened label could provide further clarity on the drug's safety profile.
Alternative Treatments
Bayer is also developing a non-hormonal competitor, elinzanetant, a dual NK1 and NK3 receptor (search) inhibitor, for moderate to severe vasomotor symptoms associated with menopause (search). This highlights the ongoing efforts to address unmet needs in menopause management with non-hormonal therapies.