Two patients died following liver damage related to taking the cancer drug Tarceva, according to a letter the FDA posted. The two patients were involved in a study with 13 other patients that the companies believed had moderate liver problems, but it turns out the problems were severe. They died within one month of completing treatment. There were 36 participants in the study in total.
OSI Pharmaceuticals manufactures the medication, which aims to treat lung and pancreatic cancers. Its partner, Genentech, sells Tarceva.
As a result, the drug now has stronger liver toxicity warnings on its label. The companies sent a letter to physicians yesterday that emphasizes the importance of close monitoring of patients taking the drug if the patients have liver problems.
The FDA approved Tarceva in 2004.
- view the letter [1] (.pdf)
- read the Business Week report [2]
- see what News Day has to say [3]
Related Articles:
Roche, Cipla trade jabs on Tarceva [4]
Tarceva gets Japan's nod [5]
Links:
[1] http://www.fda.gov/medwAtch/safety/2008/tarceva_dhcp_letter.pdf
[2] http://www.businessweek.com/ap/financialnews/D93CKKI80.htm
[3] http://www.newsday.com/news/local/suffolk/ny-bztar245855510sep24,0,1149844.story
[4] http://www.fiercepharma.com/story/roche-cipla-trade-jabs-on-tarceva/2008-04-21
[5] http://www.fiercepharma.com/story/also-noted-tarceva-gets-japans-nod-fda-blesses-novartis-arthritis-remedy/2007-10-22