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 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.

In a statement, Astellas officials said a boxed warning is used in many situations, including highlighting warning information that is particularly important to the prescriber and patient. In the case of this label update, the prominence of the already available warning on hepatotoxicity has been increased through the boxed warning.

In September, a spokesperson with Astellas said the company had added to the label information about the need for additional testing for liver values, as well as guidance on when to seek medical attention and when to discontinue Veozah.

"It’s important to note that the overall benefit-risk of Veozah has not changed and remains positive, but we want to further ensure that patients and healthcare providers are aware of the potential side effects of VEOZAH, and the hepatic laboratory testing, as it relates to its benefit to help reduce moderate to severe vasomotor symptoms (VMS) due to menopause," company officials said.