FDA Adds Black Box Warning for Liver Injury to Fezolinetant

The Food and Drug Administration (FDA) has added a boxed warning about liver injury to fezolinetant (Veozah), a drug often prescribed for hot flashes in menopausal women, according to an FDA statement.

The warning is based on data from a postmarketing report of an individual who experienced elevated liver blood test values as well as symptoms of liver injury after approximately 40 days of taking fezolinetant, according to the statement.

The boxed warning is in addition to the existing warning about elevated liver blood test values and requirements for liver blood testing in the prescribing information.

The updated information also includes recommendations to increase the frequency of liver blood testing to monthly testing for 2 months after starting fezolinetant, then following the previous recommendations for testing at 3, 6, and 9 months.

In addition, the new information advises patients to discontinue the drug immediately and contact their prescribing healthcare professional if signs of liver injury occur, according to the statement. These signs may include nausea, vomiting, unusual itching, light-colored stool, jaundice, dark urine, abdominal swelling, or pain in the right upper abdomen.

The risk for liver injury is real, but rare, said Kathryn Marko, MD, assistant professor of obstetrics and gynecology at George Washington University, Washington, DC, in an interview.

Clinicians should advise patients that their liver function will be monitored closely if they take fezolinetant, Marko said. If elevations in liver function tests occur, they often return to normal after stopping the drug, she added.

Clinical Implications and Research Gaps

The boxed warning may affect prescribing patterns in that patients or clinicians may fear the risk for liver injury, Marko told Medscape Medical News. “In addition, patients may be hesitant to start a medication that requires frequent blood test monitoring,” she said. However, many alternative treatments are available for vasomotor symptoms of menopause, including hormonal and nonhormonal therapies, and patients and physicians should work together to come up with the best option for each individual, she noted.

“More research is needed to discover new therapies for menopause,” said Marko. “Veozah is unique in its mechanism of action, and it would be wonderful to see more new medications coming down the pipeline,” she said.

Marko had no financial conflicts to disclose.