FDA issues alert about HIV drug Prezista

Mar 24, 2008

The U.S. Food and Drug Administration has issued an alert concerning reports of liver injury in patients taking Prezista.

The FDA said Prezista (darunavir), an anti-retroviral drug used to treat for the human immunodeficiency virus HIV, is suspected of contributing to several hepatic events, including liver failure, destruction of liver tissue, cirrhosis, hepatitis and jaundice.

Healthcare professionals were advised to conduct appropriate laboratory testing prior to and after starting patients on Prezista and to be alert for symptoms of hepatotoxicity, including unexplained fatigue, anorexia, nausea, jaundice, dark urine and liver tenderness.

Patients with chronic hepatitis B or C or those who have pretreatment elevations of liver function tests should be monitored more frequently.

The FDA said it worked with the drug's manufacturer -- Tibotec Therapeutics Inc. of Bridgewater, N.J. -- to include the new hepatotoxicity information on the drug's label.

Copyright 2008 by United Press International

Explore further: Investigational HIV vaccine regimen shows encouraging results in non-human primates

Related Stories

Research shows 'mulch fungus' causes turfgrass disease

5 hours ago

Inadvertently continuing a line of study they conducted about 15 years ago, a team of Penn State researchers recently discovered the causal agent for an emerging turfgrass disease affecting golf courses around ...

Study on pesticides in lab rat feed causes a stir

7 hours ago

French scientists published evidence Thursday of pesticide contamination of lab rat feed which they said discredited historic toxicity studies, though commentators questioned the analysis.

Experiments open window on landscape formation

7 hours ago

University of Oregon geologists have seen ridges and valleys form in real time and—even though the work was a fast-forwarded operation done in a laboratory setting—they now have an idea of how climate ...

To conduct, or to insulate? That is the question

7 hours ago

A new study has discovered mysterious behaviour of a material that acts like an insulator in certain measurements, but simultaneously acts like a conductor in others. In an insulator, electrons are largely stuck in one place, ...

Recommended for you

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.