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| |  FDA Warns of New Serious Adverse Events With Erlotinib ROCKVILLE, Md -- May 8, 2009 -- The US Food and Drug Administration (FDA), along with OSI and Genentech are notifying healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for erlotinib (Tarceva). Gastrointestinal (GI) 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 erlotinib. Patients receiving concomitant anti-angiogenic agents, corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease are at increased risk. Physicians should permanently discontinue erlotinib in patients who develop GI perforation. Treatment should be interrupted or discontinued in patients who develop severe bullous, blistering, or exfoliating conditions. Other ocular disorders including abnormal eyelash growth, keratoconjunctivitis sicca or keratitis have been observed with erlotinib treatment and are known risk factors for corneal ulceration/perforation. Physicians should interrupt or discontinue erlotinib if patients present with acute/worsening ocular disorders such as eye pain. The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports. SOURCE: US Food and Drug Administration
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