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Bridget M. Kuehn

JAMA. 2009;301(24):2542.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The US Food and Drug Administration is alerting physicians to new safety warnings on the label of erlotinib, a drug approved for the treatment of certain patients with lung or pancreatic cancer, that warn of reports of serious gastrointestinal tract, skin, and ocular disorders in patients taking the drug.

The drug's makers, OSI Pharmaceuticals and Genentech, have also issued a letter to physicians alerting them to postmarketing reports of such adverse events (http://www.fda.gov/medwatch/safety/2009/Tarceva_DHCP_Letter_April09.pdf). According to the letter, some individuals taking erlotinib have developed gastrointestinal tract perforation, including some deaths. Physicians are warned to permanently stop erlotinib therapy in patients who develop a perforation.

Additionally, the companies noted reports of bullous, blistering, and exfoliative skin conditions associated with erlotinib therapy. Some of the cases, including ones which resulted in death, were suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis. The letter also noted that ocular disorders such as . . . [Full Text of this Article]

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