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: Global research reaches for consensus on HIV treatment response

add to favorites email to friend print save as pdf

Related Stories

Scientists get set for simulated nuclear inspection

20 hours ago

Some 40 scientists and technicians from around the world will descend on Jordan in November to take part in a simulated on-site inspection of a suspected nuclear test site on the banks of the Dead Sea.

Alibaba IPO comes with unusual structure

20 hours ago

Foreigners who want to buy Alibaba Group shares in the Chinese e-commerce giant's U.S. public offering will need to get comfortable with an unusual business structure.

Recommended for you

HIV lessons from the Mississippi Baby

Aug 29, 2014

(Medical Xpress)—The news in July that HIV had returned in a Mississippi toddler after a two-year treatment-free remission dashed the hopes of clinicians, HIV researchers and the public at large tantalized ...

User comments : 0