The FDA has issued a new warning about the rare but serious risk of liver injury associated with Veozah (fezolinetant), a treatment for hot flashes caused by menopause. Healthcare professionals are advised to monitor liver function tests regularly, and patients should discontinue the medication if signs of liver injury occur.
Key Findings
Risk of Serious Liver Injury: Veozah can cause rare but serious liver damage.
Increased Monitoring: Liver blood tests should be conducted before starting Veozah, monthly for the first three months, and then at months 6 and 9.
Patient Education: Patients should be informed about signs of liver injury and instructed to discontinue use and consult a healthcare provider if symptoms occur.
Updated Prescribing Information: The medication's prescribing information now includes the new warning and monitoring recommendations.
How It Works
Veozah (fezolinetant) is a nonhormonal medication classified as a neurokinin 3 (NK3) receptor antagonist. It works by blocking the NK3 receptor, helping to balance estrogen levels and neurokinin B in the brain, which regulates body temperature and reduces hot flashes.
Why This Matters
The updated warning highlights the importance of vigilant liver monitoring for patients using Veozah. Early detection of liver issues can prevent severe complications, ensuring the safe use of the medication for managing menopausal symptoms.
In Practice
Pre-Treatment Testing: Conduct baseline liver function tests before initiating Veozah.
Ongoing Monitoring: Perform liver tests monthly for the first three months, then at months 6 and 9.
Patient Communication: Educate patients on recognizing liver injury symptoms like unusual fatigue, nausea, itching, jaundice, dark urine, or abdominal pain.
Action Plan: Advise patients to stop taking Veozah immediately and consult a healthcare provider if symptoms occur.
Beyond the Headline
The warning was added after a reported case where a patient developed serious liver injury within 40 days of starting Veozah. Symptoms resolved after discontinuation, emphasizing the need for awareness and prompt action if liver issues arise.
Big Picture
This development underscores the role of post-marketing surveillance in drug safety. It serves as a reminder that ongoing monitoring and patient education are essential components of healthcare, particularly when prescribing new medications.
Ethical Considerations
Balancing the benefits of symptom relief with the potential risks requires informed consent. Healthcare providers must ensure patients understand both the advantages and potential side effects of Veozah.
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