FDA Issues Warning of Liver Failure and Death Associated with Tarceva

Results From a Clinical Study

The FDA, OSI and Genentech have issued a warning today about the drug Tarceva, also known as erlotinib, based on cases of liver failure and hepatorenal syndrome, including fatalities reported during its use, particularly in patients with baseline hepatic impairment.

Tarceva monotherapy is FDA approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. It is also approved in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

The new safety information comes from a pharmacokinetic study in patients with advanced solid tumors and moderate hepatic impairment. The warning states that patients with liver impairement who are receiving Tarveca, should be monitored closely, and the drug should be used with extra caution in certain patients.

SEPT-23-08: Tarceva Causing Liver Faliure and Death [FDA: TARCEVA SAFETY INFORMATION]

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Published on Sep-23-08