Significant Hepatic Damage Linked to Veozah (fezolinetant) Usage for Managing Hot Flashes

Significant Hepatic Damage Linked to Veozah (fezolinetant) Usage for Managing Hot Flashes

Significant Hepatic Damage Linked to Veozah (fezolinetant) Usage for Managing Hot Flashes

[Posted 9/12/2024]

AUDIENCE: Patient, Health Care Provider, OBGYN, Endocrinologists

ISSUE: The FDA has issued a warning regarding Veozah (fezolinetant), a medication designed to alleviate hot flashes associated with menopause. This medicine has been linked to rare yet severe liver injury. If individuals exhibit any indications of liver injury, discontinuing the medication could halt further deterioration and may allow liver function to normalize.

As part of this update, the FDA has integrated a warning about potential liver injuries into the existing guidance concerning elevated liver function test values, along with mandating liver function assessments in the prescribing information for Veozah. This action follows an investigation into a post-marketing report involving a patient who exhibited increased liver function test values and symptoms of liver injury after approximately 40 days of treatment. New recommendations have also been provided for patients and healthcare providers to enhance liver function testing, advocating for monthly tests for the subsequent two months after initiating Veozah, followed by checks at months 3, 6, and 9 of therapy. The revised prescribing information instructs patients to cease the medication immediately and reach out to their healthcare provider if liver injury symptoms arise.

BACKGROUND: Veozah (fezolinetant) is a non-hormonal prescription medication that gained approval in May 2023 for diminishing the occurrence and intensity of moderate to severe hot flashes triggered by menopause. This drug belongs to a class known as neurokinin 3 (NK3) receptor antagonists. Its action involves rebalancing estrogen hormones and a neurotransmitter called neurokinin B (NKB) by obstructing the activity of the NK3 receptor that is instrumental in the brain’s regulation of body temperature.

RECOMMENDATIONS: 

Patients and Caregivers

  • Patients should discontinue using Veozah immediately and consult their prescribing healthcare provider if they experience symptoms indicative of liver issues. Such symptoms may include: unusual fatigue, nausea, vomiting, significant itching, pale stools, jaundice (yellowing of the skin or eyes), dark urine, abdominal swelling, or pain in the upper right abdomen.

  • Your healthcare provider will conduct blood tests prior to starting Veozah and during treatment to evaluate liver functionality.

  • Engage with your healthcare provider regarding the risks and advantages of Veozah, and voice any inquiries or concerns you may have about alternative treatment options.

Healthcare Professionals

  • Healthcare professionals should perform hepatic laboratory evaluations before prescribing Veozah, then continue these assessments monthly for the first three months of treatment, and subsequently at the 6th and 9th months.

  • When prescribing Veozah, healthcare professionals should inform patients about the potential for elevated liver enzyme levels and the rare but serious risk of liver injury while advising on the importance of regular monitoring.

  • Outline the signs and symptoms of liver injury and instruct patients to stop using Veozah promptly and to contact their healthcare provider if any such symptoms appear during treatment.

Related Information

[9/12/2024 – Drug Safety Communication – FDA]