Genentech Warns Of Liver Damage From Tarceva
1 CommentBy Ed Silverman // September 24th, 2008 // 7:46 am
A letter went out alerting docs about cases of liver damage among patients who took the cancer med in a post-approval study. One patient died from rapidly progressing liver failure and another died from a liver complication called hepatorenal syndrome, according to the letter sent by Genentech and OSI Pharmaceuticals.
Tarceva is an oral drug approved for treating lung or pancreatic cancer. Most of the 36 patients in the study had types of tumors that are not approved for treatment with Tarceva. A Genentech spokeswoman tells Reuters the prescribing info already included a “precaution” about liver damage including fatalities. That language has been moved to the stronger “warnings” section of the label.
Salmon
Moving things up from precautions to warnings to highlight a danger may have worked in the past but this is no longer an option.
Under the new Physicians Labeling Rule that is supposed to make labeling clearer, the warnings and precautions have been combined into a single section so it’s actually harder to see what is more significant. Even if it’s in the old labeling format it’s supposed to be switched over.
I also have to question why FDA would put hepatotoxicity and death in precautions in the first place. A precaution is something you should look for ahead of time (e.g. first dose hypotension) and is not so serious.
I believe this highlights some of the subtle ways in which FDA is helping Pharma hid safety info even when it is available.
Congress needs to specify clear criteria for various levels of safety information.