FDA warns that Veozah can cause serious liver injury

On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury.

Marketed by Japanese drug major Astellas Pharma (TYO: 4502), Veozah is a nonhormonal prescription medicine approved by the FDA in May 2023to reduce the frequency and severity of moderate to severe hot flashes caused by menopause. Astellas’ shares were down 4.7% at 1,705 yen today.

The FDA made this update after reviewing a post-marketing report of a patient with elevated liver function test values and signs and symptoms of liver injury after taking the medicine for about 40 days. The FDA also added new recommendations for patients and health care professionals about increasing the frequency of liver function testing, adding monthly testing for the next two months after starting Veozah, and then at months 3, 6, and 9 of treatment as already recommended.