FDA Adds Veozah Liver Injury Warnings in “Black Box” on Menopause Drug’s Label

Doctors are urged to tell patients to stop using Veozah immediately if they experience symptoms of liver problems, like jaundice.

Federal drug regulators have added a “black box” label warning about the potential side effects of Veozah, alerting medical professionals and patients about the risk of rare, but serious, liver injuries linked to the menopause medication.

Veozah (fezonlinetant) was approved last year for the treatment of moderate to severe hot flashes during menopause, as part of  a class of medications known as neurokinin 3 (NK3) receptor agonists, which affect the brain’s control of body temperature.

In September 2024, the U.S. Food and Drug Administration (FDA) issued a safety communication warning about Veozah liver problems and urging patients to stop taking the drug if they experienced signs or symptoms of liver injury. The agency has also now ordered that new liver injury warnings be added to the drug’s label.

In a Veozah warning update issued on December 16, the FDA indicates that information about the risk of liver injuries will be placed in a prominent “black box” on the drug label, which is the strongest warning the agency can require a prescription medication to carry.

The warning alerts patients about the risk of hepatotoxicity that may result from Veozah side effects, and advises doctors to perform regular liver testing before and during treatment.

The label warning also tells doctors to advise patients to discontinue Veozah immediately and seek medical attention, including liver testing, if they begin to experience signs of liver injury, which can include:

• New Onset Fatigue
• Decreased Appetite
• Nausea
• Vomiting
• Pruritus (itchiness)
• Jaundice
• Pale Feces
• Dark Urine
• Abdominal Pain

The Warnings and Indications section of the drug label indicates that postmarketing data revealed cases of Veozah liver injury occurring within 40 days of starting treatment.

While the potential liver side effects from Veozah can be serious, the label indicates that for most patients the symptoms gradually resolved after discontinuing the drug.

As a result, the FDA urges consumers and doctors to report Veozah liver injuries to the FDA Medwatch adverse event reporting program.