FDA

FDA adds boxed warning to Veozah for rare, serious liver injury risk

December 17, 2024

FDA added a boxed warning to Veozah (fezolinetant), highlighting the risk of liver injury associated with its use. Earlier this year, the agency issued a warning about the potential for hepatotoxicity with the medication.

The updated prescribing guidelines recommend hepatic lab tests before starting treatment to establish a baseline. Follow-up testing is advised monthly for the first three months, then at six and nine months.

Patients should not begin Veozah if initial tests show aminotransferase or bilirubin levels at or above twice the upper limit of normal (ULN). The medication should be discontinued if transaminase levels exceed five times the ULN, or if transaminase levels are more than three times the ULN with bilirubin levels over twice the ULN. More frequent testing is recommended if transaminase levels are above three times the ULN until resolved.

Patients experiencing symptoms of liver injury should stop taking Veozah and seek medical attention immediately. Early intervention can prevent worsening liver injury and potentially restore normal liver function.

Source:

FDA. (2024, December 16). FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due?utm_medium=email&utm_source=govdelivery