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FDA Warning for Prezista Liver Damage

Mar 24, 2008 | Parker Waichman LLP

Prezista, a medication used to treat HIV, has been linked to liver damage,  the Food & Drug Administration (FDA) warned on Friday.  In addition to the warning, the FDA said that  Johnson & Johnson's Tibotec Therapeutics, the maker of Prezista, has sent a Dear Healthcare Professional letter to doctors, and the prescribing information and the package insert of Prezista have been changed to reflect the liver damage warning.

Prezista is a protease inhibitor approved for the treatment of HIV in antiretroviral treatment-experienced adult patients. It is given with another HIV drug, ritonavir, which is known to be associated with liver toxicity.  The FDA noted that, in general, antiretroviral medications are associated with liver enzyme elevations.

According to the FDA, Prezista may be related to liver adverse events in 24 cases, including hepatic failure, hepatic necrosis, cirrhosis, hepatitis, jaundice and increased liver function tests. In all cases, patients were taking other drugs or had underlying medical conditions that may have contributed, the agency said. In nine of the 24 cases, the patient reported co-infection with hepatitis B or C.  

The agency highlighted five cases, which it said were "Among the most convincing cases from clinical trials and postmarketing reports that had a potential relationship to Prezista".    These included:

  • A biopsy-proven drug-induced liver injury in a patient with a history of alcohol use.
  • Acute hepatitis with elevated liver enzymes in a patient co-infected with chronic hepatitis B. The condition abated when Prezista and other anti-retrovirals were stopped and recurred when they were restarted.
  • Two cases of biopsy-proven drug-induced liver injury in patients not co-infected with hepatitis B or C.
  • Acute hepatitis with a drug-induced hypersensitivity reaction in a patient with chronic hepatitis B. All anti-retrovirals were stopped and restarted except Prezista, and the hepatitis did not recur.

According to the FDA, the package insert for Prezista now states that physicians should order appropriate liver 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.  Finally, doctors should consider interrupting or discontinuing Prezista if there's evidence of new or worsening liver injury.



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