May 11, 2009
Additional warnings for TarcevaThe labeling for Tarceva (erlotinib tablets, from OSI and Genentech) has been updated to include warnings about cases, some of which were fatal, of gastrointestinal perforation, bullous blistering, and exfoliative skin conditions (including cases suggestive of Stevens-Johnson syndrome, toxic epidermal necrolysis), and ocular disorders (eg, corneal perforation or ulceration). This update is based on new safety information from routine pharmacovigilance activities of clinical study and postmarketing reports.
Tarceva is indicated as monotherapy for locally advanced or metastatic non-small cell lung cancer (NSLCL) after failure of at least one prior chemotherapy regimen. It is also indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150596.htm.