OSI warns of death from liver damage with cancer drug

http://www.newsday.com/news/local/suffolk/ny-bztar245855510sep24,0,1149844. story

OSI warns of death from liver damage with cancer drugBY KATHLEEN KERR | kathleen.kerr@newsday.com
September 24, 2008

OSI Pharmaceuticals of Melville and its partner, California-based Genentech Inc., warned doctors Tuesday that two patients had died of liver damage after taking the cancer drug Tarceva.

OSI has marketed Tarceva -- used to treat lung and pancreatic cancer -- as its star product. OSI makes the drug and Genentech markets it.

Tuesday, OSI said it had added new warnings to Tarceva's label emphasizing the possibility of fatal liver damage in some patients. The warnings stemmed from a study that found liver complications in some Tarceva users. The reports surfaced after the Food and Drug Administration approved Tarceva in 2004, said OSI spokeswoman Kim Wittig.

OSI and Genentech also issued a so-called "Dear Doctor" letter warning physicians to carefully monitor patients with histories of liver problems. The letters are issued sparingly and usually inform physicians about serious side effects linked to pharmaceuticals. The FDA has posted the letter on its Web site.

Wittig said the company "voluntarily issued the 'dear doctor' letter to inform physicians" about the changes to Tarceva's label, noting that care should be taken in prescribing the drug for patients with liver problems.

"Patients who have hepatic impairment should be monitored closely by their physicians," Wittig said.

The OSI study involved 36 patients. The company found that two patients died of liver complications within 30 days of taking their last dose of Tarceva. It was thought that 15 of the study participants had moderate liver problems, but later they were found to have more severe disease, Wittig said.

Tarceva's label already contained cautions about possible liver failure and fatalities, Wittig noted. That information has now been expanded and moved to the warnings section of the label, to emphasize the possible side effects of the cancer drug on the liver.

Wittig said about 250,000 patients have taken Tarceva worldwide and that she knew of no lawsuits in connection with the deaths.