FDA issues alert about HIV drug Prezista

March 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

Related Stories

Recommended for you

How the finch changes its tune

August 3, 2015

Like top musicians, songbirds train from a young age to weed out errors and trim variability from their songs, ultimately becoming consistent and reliable performers. But as with human musicians, even the best are not machines. ...

Cow embryos reveal new type of chromosome chimera

May 27, 2016

I've often wondered what happens between the time an egg is fertilized and the time the ball of cells that it becomes nestles into the uterine lining. It's a period that we know very little about, a black box of developmental ...

Shaving time to test antidotes for nerve agents

February 29, 2016

Imagine you wanted to know how much energy it took to bike up a mountain, but couldn't finish the ride to the peak yourself. So, to get the total energy required, you and a team of friends strap energy meters to your bikes ...

0 comments

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.