FDA places its most serious warning on menopause drug due to risk of liver injury

The US Food and Drug Administration has placed its most serious warning – a so-called black-box warning – on a drug used to relieve menopausal hot flashes.

The FDA says women who are taking Veozah may need more frequent blood testing to check for markers of liver problems.

In rare cases, the drug may seriously injure the liver, and patients with symptoms including fatigue, unusual itching, nausea, vomiting, light-colored stools, dark urine, or yellow skin or eyes should tell their doctors and stop taking the medication, the FDA said Tuesday in a drug safety communication.

Astellas, the drug’s manufacturer, said in a statement that patient safety is its top priority.

“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, the company said.

Veozah was approved in 2023. It works without hormones to reduce hot flashes by blocking a receptor called neurokinin B, which plays a role in the brain’s regulation of body temperature.

Since its approval, use of the medication has steadily increased. In May, nearly 29,000 patients picked up the pills from retail pharmacies in the United States, the FDA said.

The FDA first warned in September that the drug could cause liver problems. It escalated that warning after reviewing the case of a person with blood markers of liver injury who had been taking the medication for about 40 days. After they stopped taking the medication, the patient’s symptoms gradually went away and their liver values returned to normal.

Everyone reacts differently to medication depending on their health, genes and other factors. For that reason, the FDA said, it’s impossible to know how likely it might be for any individual to develop these liver issues.

If you’re taking Veozah, it’s important to stay alert and check in with your doctor for monitoring.

The FDA said patients should have blood tests for liver markers every month for the first three months after starting Veozah and again at months six and nine. They should also stop treatment if it is recommended.