Show #88, July 2009: New Safety Information on Tarceva

New Safety Information on Tarceva


New information has been added to the labeling of the chemotherapy drug Tarceva (erlotinib). The revised labeling now warns about three kinds of serious adverse events:

• Gastrointestinal perforation, which may be fatal. This risk is increased in patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, or taxane-based chemotherapy, and it is also greater in those with a history of peptic ulceration or diverticular disease. Tarceva should be permanently discontinued if the patient develops gastrointestinal perforation.

• Bullous, blistering and exfoliative skin conditions, possibly including Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be fatal. Tarceva treatment should be interrupted or discontinued if the patient develops one of these conditions.

• Ocular disorders, including corneal perforation or ulceration. Tarceva should be interrupted or discontinued if the patient experiences symptoms of an acute or worsening eye disorder, such as eye pain.


Additional Information:
FDA MedWatch Safety Alert. Tarceva (erlotinib). May 8, 2009.