Veozah Side Effects Linked to Severe Liver Injury Risks: FDA

Doctors are being urged to conduct regular liver tests for Veozah side effects when patients begin taking the drug, in order to catch potential injuries as early as possible.

Federal drug regulators warn that side effects of Veozah, a prescription treatment for hot flashes during menopause, may increase the risk of severe liver injuries to women.

The U.S. Food and Drug Administration (FDA) issued a Veozah drug safety communication on September 12, urging users to stop taking the drug if they experience signs and symptoms of liver injury. The agency also ordered new warnings about the potential risk of liver injury to be added to the drug’s label, indicating that doctors should conduct hepatic laboratory testing before and during use.

Veozah (fezonlinetant) is a medication manufactured by Astellas Pharma, which was approved by the FDA for the treatment of moderate to severe hot flashes during menopause in 2023. It belongs to a class of medications known as neurokinin 3 (NK3) receptor agonists, which affect the brain’s control of body temperature.

The new FDA warning comes after the agency received a report of a woman suffering a serious drug-induced liver injury believed to be caused by Veozah side effects, which surfaced during the second month after treatment began.

To avoid the risk of problems among other patients, the agency is recommending that healthcare providers increase the frequency of liver function testing, adding monthly evaluations during the first two months after starting Veozah, and then repeating the testing at months three, six and nine, which was already recommended in the drug label.

“The FDA added a warning about the risk of liver injury to the existing warning about elevated liver function test values and required liver function testing in the prescribing information for Veozah,” federal regulators said. “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.”

Regulators are now advising doctors to advise their patients to stop using the drug immediately upon any signs or symptoms of liver injury from Veozah. Symptoms of Veozah liver injury can include:

• Fatigue
• Nausea
• Vomiting
• Unusual itching
• Light-colored stools
• Yellow eyes or skin (jaundice)
• Dark urine
• Stomach swelling
• Right upper abdomen pain

Health care professionals are also urged to warn patients not only about the risk of elevated liver functions when taking Veozah, but also that they may face a risk of rare, but potentially serious liver injuries as well. They should discuss the signs and symptoms of liver injury with patients and warn them to immediately stop using the drug if any of the above symptoms are present.

The FDA urges consumers and doctors to report Veozah liver injuries to the FDA Medwatch adverse event reporting program.