FDA warning about hot flash medication

The FDA warned that fezolinetant (Veozah), a hormone-free pill for moderate to severe menopausal hot flashes, could in rare cases cause serious liver damage.

If women experience signs or symptoms suggestive of liver injury, they should stop taking fezolinetant, the agency said. Symptoms include new fatigue, nausea, vomiting, pruritus, jaundice, light-colored stools, dark urine, or right upper quadrant pain.

Stopping treatment may prevent worsening liver damage and may return liver function to normal, the FDA said.

The warning was prompted by a post-marketing report submitted to the FDA's Adverse Event Reporting System (FAERS) database, which found that a patient had elevated liver enzymes in their blood and signs and symptoms of liver damage within 40 days of taking the drug.

The patient suffered from symptoms of fatigue, nausea, itching, yellow eyes and skin, pale stools and dark urine. Laboratory tests showed that the alanine transaminase (ALT) level was more than ten times the normal value, the alkaline phosphatase level was more than four times the normal value and the total bilirubin level was more than three times the normal value.

After the patient stopped taking fezolinetant, the symptoms gradually disappeared and the blood values ​​slowly returned to normal.

The agency detailed new requirements for liver blood tests on the updated label. Healthcare providers should perform basic liver blood tests to assess liver function before starting treatment, including ALT, aspartate aminotransferase (AST), alkaline phosphatase, and total and direct bilirubin. Providers should not start treatment if levels of ALT, AST, or total bilirubin are equal to or greater than 2 times the upper limit of normal (ULN).

“We also added new recommendations for patients and healthcare professionals to increase the frequency of liver blood tests, adding monthly testing for the next two months after starting treatment with Veozah and then as previously recommended at months 3, 6, and 9 of treatment,” the FDA noted in a safety notice.

If liver values ​​are elevated, alternative causes of liver damage must be ruled out.

Fezolinetant must be discontinued if transaminase levels exceed five times the ULN, or if transaminase levels exceed three times the ULN and total bilirubin exceeds more than two times the ULN. If transaminases exceed three times the ULN but total bilirubin is not more than two times the ULN, more frequent follow-up liver function tests should be performed.

Known cirrhosis was previously listed as a contraindication for the use of fezolinetant prior to this report. Other contraindications include severe renal impairment or end-stage renal failure and the use of CYP1A2 inhibitors.

The first drug in its class – an oral neurokinin-3 receptor antagonist – was approved in May 2023. It was the first non-hormonal treatment for vasomotor symptoms.