FDA ALERT [3/21/2008] - FDA is highlighting the addition of information about hepatotoxicity to the WARNINGS section of the Prezista prescribing information.  

FDA and Tibotec Therapeutics have reviewed information from clinical trials in which Prezista was administered and from postmarketing adverse event reports of hepatotoxicity in patients taking Prezista. While causality is not firmly established, an association between Prezista and hepatotoxicity is suspected.

Prezista, a protease inhibitor indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, is co-administered with ritonavir, an antiretroviral drug associated with hepatotoxicity. In general, HIV antiretroviral medications are associated with liver enzyme elevations, however, for some medications, an association with hepatotoxicity is more firmly established.

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. 

FDA has worked with the maker of Prezista, Tibotec Therapeutics, to include information about hepatotoxicity in the WARNINGS section of the prescribing information and the Patient Information (PDF - 355KB).

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