FDA Warns of Rare Serious Liver Injury with Veozah for Menopausal Hot Flashes

On September 12, 2024, the FDA issued a warning regarding Veozah (fezolinetant), a treatment for hot flashes due to menopause, highlighting the risk of rare but serious liver injury. The FDA’s advisory notes that discontinuing the medication upon the appearance of liver injury symptoms could prevent further damage and potentially restore liver function to normal.

The FDA has updated the existing safety information for Veozah to include this liver injury risk, which previously only mentioned elevated liver function test values. This decision followed a review of a post-marketing report involving a patient who exhibited elevated liver function test values and liver injury symptoms after approximately 40 days of use. Consequently, the FDA now recommends more frequent liver function testing. Specifically, patients should undergo monthly liver function tests for the first two months after starting Veozah, followed by tests at months 3, 6, and 9. The new prescribing information advises patients to halt the medication immediately and contact their healthcare provider if they experience symptoms indicative of liver injury.

Veozah (fezolinetant) is a nonhormonal medication approved in May 2023 to alleviate the frequency and severity of moderate to severe hot flashes associated with menopause. It belongs to the neurokinin 3 (NK3) receptor antagonist class of drugs. Veozah functions by blocking the NK3 receptor, which is involved in the brain’s regulation of body temperature, thereby restoring the balance between estrogen hormones and neurokinin B (NKB).

For patients and caregivers, it is crucial to be aware of the potential for liver injury when using Veozah. Symptoms of liver injury may include jaundice (yellowing of the skin or eyes), dark urine, loss of appetite, nausea, vomiting, and abdominal pain. Immediate medical attention should be sought if these symptoms occur.

Healthcare professionals are advised to adhere to the updated prescribing information, ensuring patients undergo the recommended liver function tests at the specified intervals. This vigilance is essential to detect any early signs of liver injury and to take timely action to mitigate further harm.

In summary, while Veozah provides significant relief for menopausal hot flashes, awareness and monitoring of liver function are critical to ensure patient safety.