FDA Adds Black Box Warning for Liver Injury to Fezolinetant

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FDA Adds Black Box Warning for Liver Injury to Fezolinetant
Menopausal SyndromeLiverBiliary Disease
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Updated prescribing information increases frequency of blood testing.

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

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

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Menopausal Syndrome Liver Biliary Disease Gallbladder Disease Wound Management Wound Care Injury Blood U.S. Food And Drug Administration United States Food And Drug Administration FDA Food And Drug Administration (FDA) Food And Drug Administration Abdominal Washington Washington DC Washington - District Of Columbia

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