The FDA has issued an alert warning women about menopausal medicine for hot flushes, saying fezolinetant (Veozah), a hormone-free pill, could cause rare but serious liver injury, and suggesting clinicians perform liver blood tests before and during the treatment.
The agency says if women experience any signs or symptoms suggesting liver injury, they should stop taking the drug. Symptoms include new-onset fatigue, nausea, vomiting, pruritus, jaundice, pale faeces, dark urine, or right upper quadrant pain.
Prompting the warning was a report submitted to the FDA in which a patient had elevated liver blood test values and signs and symptoms of liver injury within 40 days of starting the drug, according to Medpage Today.
Symptoms were fatigue, nausea, itching, yellow eyes and skin, light-coloured stools and dark urine. Labs indicated alanine transaminase (ALT) was more than 10 times the normal level, alkaline phosphatase was more than four times the normal level, and total bilirubin was more than three times the normal level.
Symptoms gradually resolved and blood test values slowly returned to normal after the patient stopped the medication.
The agency detailed new requirements for liver blood testing on the updated label. Healthcare providers should perform baseline liver blood tests to assess liver function prior to starting treatment, including ALT, aspartate aminotransferase (AST), alkaline phosphatase, and total and direct bilirubin, it said, and treatment should not be started if the concentrations of ALT, AST, or total bilirubin are equal to or exceed two times the upper limit of normal (ULN).
It also added new recommendations for patients and healthcare professionals about increasing the frequency of liver blood testing, adding monthly testing for the next two months after starting Veozah, and then at months three, six and nine of treatment as already recommended.
Known cirrhosis was previously listed as a contraindication to fezolinetant use before this report, while other contraindications include severe renal impairment or end-stage renal disease, and use of CYP1A2 inhibitors.
The first-in-class pill – an oral neurokinin 3 receptor antagonist – was approved in May 2023, marking the first non-hormonal treatment for vasomotor symptoms.
Medpage Today article – FDA Warning on Hot Flash Drug (Open access)
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New drug cuts number and severity of hot flushes
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