The FDA is warning about a rare but serious risk of liver injury from Vezoah (fezolinetant), a menopause drug for hot flashes.
Women who develop symptoms of liver injury should stop taking Vezoah immediately and contact the healthcare professional who prescribed the medication, according to the FDA.
The symptoms of a liver injury from Vezoah may include feeling more tired than usual, nausea, vomiting, unusual itching, light-colored stools, yellowing of the eyes or skin (jaundice), dark urine, swelling in the stomach or belly area, or pain in the right upper abdomen.
“If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury and potentially return liver function to normal,” the FDA said.
The warning was issued after the FDA reviewed a report of a person who suffered a serious liver injury within 40 days of starting Vezoah. Blood tests showed abnormal liver enzymes and bilirubin levels. After stopping Vezoah, her symptoms gradually went away, and liver blood test levels returned to normal.
The FDA is also asking doctors to discuss the signs and symptoms of liver injury and instruct patients to stop Veozah immediately if they occur at any time during treatment.