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Reuters Health Information (2008-03-13): J&J, FDA warn of liver risk with HIV drug Prezista

Regulatory

J&J, FDA warn of liver risk with HIV drug Prezista

Last Updated: 2008-03-13 18:35:03 -0400 (Reuters Health)

WASHINGTON (Reuters) - Johnson & Johnson and the U.S. Food and Drug Administration warned of reported liver damage and death in patients taking the company's HIV drug Prezista, according to a letter released on Wednesday.

The letter, sent by J&J's Tibotec Therapeutics unit to doctors this month, cited cases of drug-induced hepatitis as well as liver injury and death.

"We are issuing a new warning on our labeling," Tibotec Therapeutics spokeswoman Pam Van Houten told Reuters.

The company said in its letter that the problems have not been linked directly to Prezista (ritonavir-boosted darunavir), a once-daily protease inhibitor.

Fifteen cases of liver problems were reported during clinical trials, Van Houten said. She added the company did not provide information on post-marketing cases reported after the drug's U.S. approval in 2006.

Most of the cases occurred in patients with advanced HIV, who were taking multiple medications, as well as those who were also infected with hepatitis B or C, the letter said.

The letter and Van Houten did not say how many liver-related deaths occurred.

The FDA warning was released on its Web site at http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista .

 
 
 
 
                 
 
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