FDA Adds Liver Injury Black Box Warning to Menopause Drug Veozah

WASHINGTON, D.C. — The Food and Drug Administration has added a boxed warning to Astellas Pharma Inc.’s Veozah (fezolinetant), which cautions that the menopause drug can cause rare but serious liver injury.

In a Dec. 20 Drug Safety Communication, the agency explained that it added the warning after reviewing a postmarketing report of a patient with elevated liver blood test values and symptoms of liver injury after taking Veozah for about 40 days.

The FDA also added new recommendations about increasing the frequency of liver blood testing, adding monthly testing for the next 2 months after starting Veozah, …