FDA issues alert on safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva (erlotinib)

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FDA issues alert on safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva (erlotinib)

On May 8, 2009, the FDA Safety Information and Adverse Event Reporting Program issued the following alert to oncological, dermatological and ophthalmological healthcare professionals:

OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva. The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports. Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In combination with gemcitabine, Tarceva is also indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

The complete MedWatch 2009 Safety summary and OSI Dear Healthcare Professional Letter are available through the MedWatch Website.