FDA Adds Warning to Veozah Menopause Drug

Regulators said that the drug could lead to serious liver injury, with symptoms including fatigue, nausea, jaundice, dark urine, and abdominal pain.

The U.S. Food and Drug Administration building in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) said on Sept. 12 that it is adding a warning to Veozah, a drug used to treat hot flashes experienced because of menopause.

Veozah, also known as fezolinetant, “can cause rare but serious liver injury,” the FDA said in an alert.

The FDA added the warning after reviewing a case of serious liver injury in a person who suffered symptoms such as yellow eyes and skin and dark urine within 40 days of starting Veozah.

The symptoms eventually went away after the person stopped using the medicine, and blood test results ultimately returned to normal.

If users of the drug experience any signs or symptoms of liver injury, they should stop taking the medicine, regulators said.

Symptoms include fatigue, nausea, jaundice, dark urine, and abdominal pain.

People who suffer symptoms are advised to immediately contact their doctor, who will run blood tests and check the patient’s liver.

“All medicines have side effects even when used correctly as prescribed,” the FDA stated. “It is important to know that people respond differently to all medicines depending on their health, the diseases they have, genetic factors, other medicines they are taking, and many other factors. As a result, we cannot determine how likely it is that someone will experience these side effects when taking Veozah (fezolinetant). Your health care professionals know you best, so talk to them if you have questions or concerns about risks of taking Veozah (fezolinetant).”

The FDA approved Veozah in 2023 as a prescription medicine to treat moderate to severe hot flashes due to menopause. The agency said at the time that data from two randomized, placebo-controlled, double-blind trials demonstrated the effectiveness of the drug.

At the time of the approval, regulators said that patients should have blood work done to test for liver damage before starting Veozah and that blood tests should be performed every three months for the first nine months after starting the medication.

Other side effects of Veozah include diarrhea, insomnia, and back pain.

“Veozahuses uses a novel mechanism of action to target the root cause of VMS due to menopause,” Marci English, vice president and head of biopharma development at Astellas, said in a statement after the approval. “FDA approval of this new treatment for moderate to severe VMS due to menopause is a testament to Astellas’ commitment to delivering innovative therapies in areas of unmet need that have been underserved, including women’s health.”

Astellas Pharma Inc., which distributes Veozah in the United States, said in an emailed statement to The Epoch Times that the company is regularly working with regulators to ensure the safety profile of its medications.

“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 and therefore have added two additional timepoints for hepatic tests to the label, testing for an additional liver value, as well as guidance on when to seek medical attention and when to discontinue Veozah,” the company said.

People who want to read the full label can find it here.