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  • FDA Date: 03/21/2008

    Prezista (darunavir ethalolate) FDA Drug Safety Communication

    FDA Information for Healthcare Professionals: Darunavir Ethalolate (marketed as Prezista)

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is highlighting the addition of information about hepatotoxicity to the Warnings section of the Prezista prescribing information and Patient Information. Healthcare providers should conduct appropriate hepatic laboratory testing prior to and after starting patients on Prezista. Patients should promptly seek medical attention if they experience unexplained fatigue, anorexia, nausea, jaundice, abdominal pain, or dark urine. Healthcare professionals should consider interrupting or discontinuing Prezista if evidence of new or worsening liver injury arises.

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    View the full FDA Drug Safety Communication on FDA.gov