FDA Adds Boxed Warning to Veozah Label

The FDA is adding a boxed warning to the label of Astellas’ Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause. Regulators are taking this step after a postmarketing report of a patient with elevated liver blood test values and signs and symptoms of liver injury after taking the medicine for about 40 days. The case was reported to the FDA Adverse Event Reporting System (FAERS) database.

FDA officials are also providing new recommendations about increasing the frequency of liver blood testing, adding monthly testing for the first two months after starting Veozah, and then at months three, six, and month of treatment. The updated prescribing information also includes instructions to stop the medicine if there are signs and symptoms of liver injury.

The FDA had approved Veozah in May 2023 as an oral therapy to treat moderate-to-severe vasomotor symptoms, or hot flashes, caused by menopause. It is a nonhormonal medicine that works by blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.

Related: FDA Warns of Liver Injury with Veozah for Hot Flashes

In September 2024, regulators issued a safety notice about the risk of liver injury from the use of Veozah based on a case reported to the FDA Adverse Event Reporting System (FAERS) database. A patient experienced symptoms of fatigue, nausea, itching, yellow eyes and skin, light-colored stools, and dark urine after starting Veozah. Liver blood test values were elevated, including abnormal liver enzymes and bilirubin levels, which returned to normal after stopping the medication.

At the time, a spokesperson with Astellas said the company had added to the label addition testing for liver values, as well as guidance on when to seek medical attention and when to discontinue Veozah.

“We are committed to ensuring the hepatic laboratory testing protocol in the Veozah U.S. prescribing information identifies patients at risk for or experiencing symptoms of potential drug induced liver injury as early as possible,” the spokesperson said.

In the Veozah clinical trials, the frequency of elevated liver enzymes was low across groups, and elevations were generally asymptomatic, isolated, transient and resolved on treatment or soon after study drug discontinuation.