Tarceva Gets Warning for Potentially Deadly Side Effects

<"http://www.yourlawyer.com/practice_areas/defective_drugs">Tarceva, a drug approved to treat lung and pancreatic cancers, has been linked to serious side effects including sometimes fatal digestive tract perforations and skin reactions, as well as eye problems. The complications linked to Tarceva have prompted the Food & Drug Administration (FDA) to announce new warnings for the drug’s label.

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Tarceva is one of a class of cancer drugs known as epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. These treatments are designed to block the EGFR protein, believed to play a role in cancer cell growth.

As a monotherapy, Tarceva is approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Just this past March, Genentech Inc. and OSI Pharmaceutical Inc., the makers of Tarceva, applied to have the drug approved as a first-line maintenance treatment for lung cancer.

The new Tarceva warning was announced by the FDA on Friday. In a letter dated April 2009, Genentech and OSI said that there had been reports of patients suffering gastrointestinal perforations while undergoing Tarceva therapy. This risk is greatest for patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease. According to the letter, some instances of perforation had been fatal.

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The letter also said that some Tarceva patients had developed bullous, blistering and exfoliative skin conditions, which in some cases were suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis. Again, some of these cases resulted in deaths.

Finally, the letter warned that patients treated with Tarceva had experienced corneal perforation or ulceration. Other eye disorders including abnormal eyelash growth, keratoconjunctivitis sicca and keratitis, have also been observed with Tarceva treatment.

The letter did not say how many cases of patients with Tarceva complications were reported or how many patients died. More than 350,000 patients have been treated with Tarceva worldwide, and global sales of the drug topped $1 billion in 2008.

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