FDA issues alert about HIV drug Prezista
Published: March 24, 2008 at 9:38 AM
WASHINGTON, March 24 (UPI) -- 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.
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.
© 2008 United Press International. All Rights Reserved.
This material may not be reproduced, redistributed, or manipulated in any form.
This material may not be reproduced, redistributed, or manipulated in any form.
» Next in Science:
Charlie's-brand cantaloupe recalled
In this image from NASA's Atmospheric Infrared Sounder instrument on NASA's Aqua spacecraft, Cyclone Nargis is pictured when it was a Category one hurricane located 370 miles west of Yangon, Myanmar on May 1, 2008. Tropical Cyclone Nargis flooded the region on May 4, 2008. The death toll from the cyclone and its aftermath is feared to hit or exceed 100,000 lives. (UPI Photo/NASA/MODIS Rapid Response Team)
NASA satellite images show Tropical Cyclone Nargis in Myanmar
Full Photo
| Slideshow
Latest Headlines
- Walker's World: Georgia on my mind
- Man hospitalized for tiger scratches
- 'Math geek' stigma repels students
- Rail workers in Britain to vote on strike
- Duck selects waterfront condo for nest
- Militants gain ground in Mideast
- Spielberg gearing up to make Lincoln film
- Non-ozone-depleting pesticides sought
Most Popular