FDA, J&J Unit Warn On Liver Injuries With HIV Drug
Wednesday March 12nd, 2008 / 22h53
By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The Food and Drug Administration and a unit of Johnson & Johnson (JNJ) warned Wednesday about liver damage and some deaths in patients treated with the HIV drug Prezista. In a letter posted Wednesday to the FDA's Web site, Johnson & Johnson's Tibotec Therapeutics unit said it had received reports of liver injury and some fatalities since the drug was approved in June 2006. The company also had reports of 15 cases of drug-induced hepatitis among 3,063 patients in clinical trials. A company spokeswoman did not have post-marketing figures available on the number of liver injuries and deaths. Language about the reports of liver injuries was added to Prezista's label. The letter, however, noted that the liver-injury reports have generally occurred in patients with advanced HIV disease who were also on several other medications, as well as those who had chronic active hepatitis B or C, which puts people at higher risk for liver injury. The letter also said a causal relationship between the liver injuries and Prezista treatment had not been established. Prezista is prescribed in combination with Abbott Laboratories' (ABT) Norvir, and in many cases other HIV drugs. Prezista is a protease inhibitor aimed at blocking HIV replication. The letter said doctors should test patients before starting treatment with Prezista and continuing monitoring liver enzymes to look for signs of possible liver injury. The letter also advised interrupting or stopping treatment in patients if there's evidence of new or worsening liver dysfunction. - By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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