Practice Update: Fezolinetant FDA Warning

Fezolinetant (Veozah) is a central nervous system agent that works as an antagonist at the neurokinin 3 (NK3) receptor. This action inhibits neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron which alters activity in the thermoregulatory center of the brain. The medication was approved by the FDA in May of 2023 to improve vasomotor symptoms (hot flashes) that many women experience during menopause.

On September 12th, 2024, the FDA added a warning of a rare but serious liver injury that may occur when taking fezolinetant. When looking at postmarketing data of fezolinetant, one patient had a normal liver function blood test before initiating the medication. Within 40 days of starting the medication, the patient’s ALT reading was elevated to 10 times the normal level, ALP was more than 4 times the normal level, and total bilirubin was 3 times the normal level. The patient presented with symptoms such as fatigue, nausea, itching of the whole body, jaundice, dark urine, and pale feces. Differential diagnoses such as hepatitis were ruled out. The provider discontinued fezolinetant and the patient’s symptoms gradually improved and liver function results decreased to the normal level.

As a result, the FDA added a warning about elevated liver blood test values, which now requires testing, which is stated in the prescribing information of the drug. The FDA also added new recommendations for prescribers in regards to increasing the frequency of liver blood test; adding monthly testing for the first two months after initiation, then at 3, 6, and 9 months. Also, the FDA stated a clear recommendation to stop taking fezolinetant if a patient experiences any signs of liver injury. There was no clear evidence that certain population groups are at a higher risk for liver injury than others.

In the statement, the FDA stated, “We cannot determine how likely it is that someone will experience these side effects when taking Veozah (fezolinetant)”. The FDA is asking that people taking fezolinetant to report any side effects they experience to report them to the MedWatch program to monitor the severity and frequency of various adverse events.

For further reading, you can go to the FDA website:

https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due

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