FDA approves novel drug for hot flashes

On Thursday, September 12, 2024, the FDA issued a Drug Safety Communication warning that Veozah (fezolinetant), a medicine used to treat moderate to severe hot flashes caused by menopause, can cause rare but serious liver injury. The oral medication, manufactured by Astellas Pharma, was FDA-approved on May 12, 2023. Veozah is the first neurokinin 3 (NK3) receptor antagonist to receive approval for the treatment of vasomotor symptoms (hot flashes).  

Hot flashes are very common among people going through menopause. According to the FDA, about 80% of menopausal women experience vasomotor symptoms like hot flashes. And when they’re frequent and severe, hot flashes and night sweats can take a serious toll on a person’s quality of life—which is why the approval of Veozah is important. 

However, individuals with signs of symptoms suggesting liver injury—such as fatigue, nausea, vomiting, unusual itching, light-colored stools, jaundice (yellowing of the eyes or skin), dark urine, and abdominal pain or swelling are urged to discontinue the medication and seek medical advice from their healthcare provider.

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How Veozah works

Currently, hormone therapy is considered the most effective treatment available for this type of symptom, says Stephanie S. Faubion, MD, medical director for The North American Menopause Society. But hormone therapy isn’t for everyone. Some people have a history of heart attack, stroke, blood clots, or breast cancer, among other health conditions, that might preclude them from using this treatment. For these individuals, Veozah may be a safer—and still effective—treatment option.

Veozah works by targeting the neural activity that causes hot flashes. Specifically, it works by “binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature,” according to the FDA. The NK3 receptors are found in the central nervous system and can trigger hot flashes.

The effectiveness of Veozah in addressing hot flashes was demonstrated in two phase 3 clinical trials that each ran for a total of 52 weeks.

As yet, there have been no studies comparing Veozah to hormone therapy. “It does appear to be safe and effective and a great non-hormonal option,” Dr. Faubion says.

Who can take Veozah?

Veozah comes with a warning for elevated liver enzymes (liver injury) from the FDA, which may disqualify some people from taking it. People who have cirrhosis or severe or end-stage renal disease should not take Veozah. 

Patients will need to undergo blood work to test for liver damage before they can begin taking this medication. Additionally, people who take Veozah will need to undergo routine blood work every three months for the first nine months. 

“The benefits outweigh the risks for the majority of healthy women who are under the age of 60 and within 10 years of menopause onset who need symptom relief,” Dr. Faubion says. “It is wonderful to see a new treatment option for hot flashes and night sweats on the market. That women have more options is a good thing.”

If you are currently taking Veozah or starting the medication, be sure to discuss concerns with your healthcare provider. They can help you assess the benefits versus risks and determine if the medication is right for you based on your health history, lifestyle, and medical conditions. 

Veozah availability and cost

Veozah is available in a 45 mg oral dose intended to be taken once daily, with or without food. 

The average retail price of Veozah is $738.31 for 30, 45 mg tablets, but you can reduce the cost to about $539.90 using SingleCare’s free prescription drug discount card.