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Tarceva Warning in Canada

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Health Canada has issued a public warning regarding skin, eye and gastrointestinal complications seen in patients treated with Tarceva (erlotinib).  Last Friday, these same complications prompted the Food & Drug Administration (FDA) to mandate a new warning for the drug’s label in the U.S.

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.

According to Health Canada, Tarceva has been associated with cases of gastrointestinal perforation, skin reactions suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis, and corneal perforation.

The  Health Canada release cited 115 reports of  gastrointestinal perforation; 10 reports of skin reactions; and 6 cases of corneal perforations among patients treated with Tarceva.    Health Canada said treatment with Tarceva should be interrupted or discontinued if patients exhibit signs of any of these complications.

In some cases, the skin and digestive problems proved fatal.

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