UPDATE 2-New warnings for Tarceva cancer drug-U.S. FDA

Fri May 8, 2009 10:39pm BST
 
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* Skin, eye, digestive tract problems seen

* Some patients taking the drug died

* Warnings added to product labels (Adds company comment, paragraphs 7-8)

WASHINGTON, May 8 (Reuters) - New warnings have been added to Genentech Inc and OSI Pharmaceutical Inc's (OSIP.O) 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 (ROG.VX).

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 here#Tarceva.

The letter did not say how many cases of patients with complications were reported or how many patients died.  Continued...

 

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