Cancer Drug Tarceva Linked to Deadly and Severe Injuries, FDA Warns

The Food and Drug Administration is warning consumers and healthcare professionals about the risks of severe and in some cases fatal injuries in patients being treated for two types of lung and pancreatic cancer.

Tarceva, made by a partnership of Genentech Inc. and OSI Pharmaceutical Inc., is approved for treating locally advanced or metastatic non-small cell lung cancer that has not responded to at least one prior chemotherapy treatment. It also is approved for use, along with gemcitabine, to treat locally advanced pancreatic cancer, the FDA said.

Patients taking Tarceva have developed fatal gastrointestinal perforations, blistering and exfoliative skin conditions that are suggestive of Stevens-Johnson Syndrome (also called toxic epidermal necrolysis). Some patients also have reported suffering severe eye injuries, including corneal perforations and ulceration, according to the FDA.

The FDA has just issued a warning letter to healthcare professionals to detail the problems associated with Tarceva.

Tarceva, which in generic form is called erlotinib, is a pill taken once a day on an empty stomach that is designed to block cell tumor cell growth by targeting the protein in the body called the Human Epidermal Growth Factor Receptor 1. The drug works by inhibiting the tyrosine kinase activity of the HER1 signaling pathway inside the cancerous cell.

It was approved by the FDA in November 2004 to treat some types of lung cancer. In November 2005, the FDA approved the drug for treatment of certain forms of pancreatic cancer.

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