Is There a Link Between Veozah and Liver Failure?

I have been taking Veozah to treat my hot flushes and night sweats for the past six months, and it has been life-changing. Before I started it, I was having hot flushes and night sweats constantly. I couldn’t get a good night’s sleep because I was always waking up in a pool of sweat. But this week I saw that the FDA put out a warning about liver failure. I love my Veozah, but I don’t want to ruin my liver. I can’t take hormone therapy because I have a history of breast cancer. What should I do?

—Anonymous

For women who cannot or do not want to take hormone therapy, Veozah has been a great addition to the tool kit for treating perimenopausal symptoms. Veozah treats hot flushes and night sweats by acting like estrogen at a specific receptor in the temperature control centers in the brain. Because it does not act like estrogen in any other body systems, it is safe for women who cannot safely take estrogen.

When Veozah was approved by the FDA in 2023, the prescribing information recommended the doctors check liver enzyme tests in patients before they started the medication and after three, six, and nine months of taking it. This recommendation was made based on the last phase of clinical trials, where a small number of women, less than 2% of those taking Veozah, had changes in their liver enzymes during the trial. Only one patient had to discontinue the medication and drop out of the trial due to these liver changes.

But in December 2024, the FDA issued a new warning regarding Veozah and the possibility of liver failure. The type of warning issued sounds scary: it is called a “black box warning” — referring to how the warning is printed on the prescribing information, literally in a black box.

It is important to note that this new warning is based on a single event, in which a woman developed liver failure while taking Veozah. To put this in context, it is estimated that more than 28,000 patients took Veozah in the first 12 months after its approval. In fact, this is such a rare occurrence that the FDA admits it cannot estimate an individual’s risk of developing liver failure while taking it.

Additionally, the black box warning adds very little to the prescribing information. The FDA now recommends testing liver enzymes one and two months after starting Veozah in addition to the four tests previously recommended. It also recommends that if patients have signs of liver failure — including yellow eyes and skin, itching, and light-colored stool — within 40 days of starting Veozah, they should stop the medication and call their doctor.

Ultimately, this new black box warning will not change my prescribing habits. I still think Veozah is a great non-hormonal option for treating hot flushes and night sweats. However, I will absolutely order the additional blood tests for my patients. If you have been taking Veozah for less than three months, you should talk to your doctor about checking your liver enzymes sooner. But if you have already been taking Veozah for more than three months, it is working well for you, and if you have had your liver enzymes checked, I wouldn’t worry about it anymore.