Veozah (fezolinetant) is a relatively new medication that was approved by the FDA (U.S. Food and Drug Administration) in May of 2023 to help treat moderate to severe hot flashes related to menopause. It was approved on the basis that it could help reduce the frequency and severity of hot flashes. It is part of a class of medications called neurokinin 3 (NK3) receptor antagonists. This means the medicine works by helping bring back the balance between the estrogen hormones and a specific brain chemical using the NK3 receptor to do so. The approval of this medication in May of last year was a novel development because no medication for hot flashes had been developed using the NK3 receptor yet. Another benefit of the medication is that it is nonhormonal and taken once daily by mouth.
What are the main side effects?
The most common side effects of the medication Veozah were abdominal pain, diarrhea, insomnia, back pain, hot flushes/flashes, and elevated liver enzymes. According to the package insert, the medication is contraindicated (should not be used) in patients with known cirrhosis, severe kidney impairment (or end-stage kidney disease), or those taking certain types of medications called CYP1A2 inhibitors. CYP1A2 inhibitors could include medicines like ethinyl estradiol, cimetidine (Tagamet), ciprofloxacin (Cipro), fluvoxamine, and mexiletine, for example.
What is the FDA warning about?
In September 2024, the FDA released an announcement indicating a safety concern with Veozah. The FDA warned that Veozah can cause rare, but serious, liver injury. These warnings can help make patients and providers aware of what to look out for. The FDA recommended discontinuing the medication if there are any signs or symptoms of liver injury. Signs or symptoms of liver injury can include feeling more tired than usual, nausea, vomiting, unusual itching, yellowing of the eyes or skin (jaundice), dark urine, swelling in the belly area, and/or pain in the right upper abdomen.
This is an additional warning to the already existing warning for the medication about elevated liver blood tests. The FDA reports that this warning comes after there was one report of a patient with elevated liver blood tests and signs and symptoms of liver injury after taking Veozah for 40 days. With this information, health care providers should increase monitoring of liver function tests in the intervals suggested by the FDA. If you think you could be experiencing liver injury related to Veozah, stop the medication and speak with your health care provider.
Disclaimer: This blog is written for informational and educational purposes only. It is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read or seen online.
Resources:
1) FDA warning: https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due
2) FDA approval of Veozah: https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause
3) Veozah website: veozah.com
4) Veozah package insert: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216578s003lbl.pdf
5) https://www.pharmacytimes.com/view/2007-11-8279
