this drug has a big old nasty aniline moiety on it...does anyone have any convincing data that this drug doesn't destroy the liver...heck put an aniline on a drug and you might as well throw a hand grenade in your liver.
also, bromfenac liver failure set in as early #$%$ days...I just want to see the ALT and AST numbers from a 1000 patient study before I'm convinced and then run a study where those same 1000 people get drunk on the 5th day of treatment and provide AST and ALT numbers again then i'll be convinced of its safety.
here is the scenario...this is a 7 day regimen by the 3 or 4 day you start feeling better get wasted one night by the 5 or 6th day you are in liver failure...there is a reason you never see a drug with amino benzene's in them. I would not be surprised to see this happen, then the solithro gets black boxed and now doctors dont want to go near it...look up bromphenac and you will see what I mean. but hey don't get me wrong cempra will go to 14 to 16 by its pdufa...im just saying long term be careful.
This is actually the scientific explanation as to why we have not seen serious safety issues.
The only currently marketed ketolide, telithromycin, suffers from rare, but serious side effects. Recent studies have shown this to be likely due to the presence of the pyridine-imidazole group of the telithromycin side chain acting as an antagonist towards various nicotinic acetylcholine receptors. Since solithromycin, like azithromycin and clarithromycin, lacks this chemical moiety, it is not expected to cause the adverse events seen with Ketek (telithromycin).