OCTOBER 8, 2024

FDA Adds Warning of Serious Liver Injury to Menopause Drug

The FDA has added a warning of a rare occurrence of serious liver injury in patients taking the drug fezolinetant (Veozah, Astellas) to manage hot flashes caused by menopause.

Fezolinetant, the first approved neurokinin 3 receptor antagonist, already carried a contraindication for patients with known cirrhosis when it was approved in May 2023. In addition, the drug carried a warning about elevated liver blood test values, and baseline blood work to evaluate hepatic function and injury at three,