• Posted December 18, 2024

FDA: Veozah, First Hormone-Free Hot Flash Drug, Issued Black Box Warning

The U.S. Food and Drug Administration (FDA) has issued its most serious warning -- a black-box warning -- for Veozah, a medication used to relieve hot flashes in menopausal women, due to rare but potentially severe liver risks.

In new communication issued Dec. 17, the FDA advised that women taking Veozah should undergo regular blood testing to monitor liver health.

Warning signs of liver injury can include fatigue, nausea, vomiting, dark urine, light-colored stool, or yellowing of the skin or eyes, a news release says.

Patients experiencing these symptoms should immediately stop taking the medication and consult with their doctor.

“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,” as well as recommended lab testing, Astellas Pharma, the manufacturer of the drug, said in a statement.

Veozah was approved in 2023. At the time, it was the first non-hormonal prescription option for treating hot flashes.

The medication works by blocking neurokinin B, a receptor involved in the brain’s regulation of body temperature.

Since its approval, the drug's popularity has grown steadily, with nearly 29,000 prescriptions filled in May 2024 alone, according to FDA data.

The FDA’s heightened warning comes after reviewing a recent case where a patient developed elevated liver markers after taking Veozah for about 40 days.

The patient’s symptoms resolved, and liver function normalized after stopping the medication.

To minimize risk, the FDA recommends monthly blood tests for liver markers during the first three months of Veozah treatment and follow-up tests at months six and nine.

Because medication effects can vary widely due to health, genetics, and other factors, the FDA emphasized that it is difficult to predict who might develop liver issues.

More information

The Menopause Society has more on treatments for hot flashes during menopause.

SOURCE: U.S. Food and Drug Administration (FDA), release, Dec. 16 2024; CNN, report, Dec. 17, 2024