On March 21, 2008, the U.S. Food and Drug Administration (FDA) warned consumers that the anti-HIV drug Prezista, known generically as darunavir, may be associated with hepatoxicity, or liver injury. The warning comes after the FDA received 24 reports of liver injury, including some fatalities, in conjunction with Prezista use.

The drug, manufactured by Tibotec Therapeutics, has not been definitively established as the cause of the liver injuries reported.

Prescribing information on Prezista’s package insert now advises:

• Physicians should undertake appropriate hepatic laboratory testing before and after starting patients on the drug.
• Patients should seek medical attention if they have unexplained fatigue, anorexia, nausea, jaundice, abdominal pain, or dark urine.
• Doctors should consider interrupting or discontinuing darunavir if there’s evidence of new or worsening liver injury.

Prezista is approved to treat HIV in antiretroviral treatment-experienced adult patients. 24 adverse event reports received by the FDA involving hepatic failure, hepatic necrosis, cirrhosis, hepatitis, jaundice, and increased liver function tests, however, led the agency to suggest darunavir may be related.

Source: Michael Smith, “Liver injury linked to Darunavir (Prezista),” MedPage Today, March 21, 2008 (http://www.medpagetoday.com/InfectiousDisease/HIVAIDS/tb1/8854).