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Old 05-08-2009, 06:19 PM
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Default New warnings for Tarceva cancer drug: FDA

New warnings have been added to Genentech Inc and OSI Pharmaceutical Inc's cancer drug Tarceva about reports of skin reactions, eye problems and holes in the digestive tract, U.S. health regulators said on Friday.


Patients have died in some cases, the U.S. Food and Drug Administration said.
The FDA said some of the skin problems seen in Tarceva patients suggest serious disorders such as Stevens-Johnson syndrome or toxic epidermal necrolysis. A warning also was added about reports of eye problems such as ulcers and corneal perforations, the agency said.
Genentech is a unit of Roche Holding AG.
The companies sent a letter about the warnings to doctors and other health care providers in April. The FDA made the letter public on Friday on its website at http://www.fda.gov/medwatch/safety/2...09.htm#Tarceva.
The letter did not say how many cases of patients with complications were reported or how many patients died.
OSI spokeswoman Kathy Galante said the number of patients who developed serious skin conditions was "in the low single-digit range" out of more than 350,000 patients who have been treated with Tarceva worldwide.
Tarceva's global sales topped $1 billion in 2008. Galante said she did not expect the new warnings to impact future sales.
"We don't see this to have an effect from the financial perspective on Tarceva," she said.
Tarceva is approved to treat certain patients with lung cancer or pancreatic cancer.
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