Warning of liver damage issued for Prezista

WASHINGTON Tibotec Therapeutics, a unit of Johnson & Johnson, and the Food and Drug Administration warned of liver damage and some deaths in patients who were treated with the HIV drug Prezista. The drug, which is prescribed in combination with Abbott’s Norvir, is used to block HIV replication.

The company has been receiving reports of liver damage and deaths since the drug was approved in June 2006. Tibotec also announced reports of 15 cases of drug-induced hepatitis among patients in clinical trials.

The letter on the FDA’s Web site 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.