FDA Issues Ketek Public Health Advisory Regarding Liver Toxicity
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency is evaluating three cases of severe hepatotoxicity, including one death, to determine if a labeling change is necessary for Sanofi-Aventis' antibiotic.
You may also be interested in...
Ketek Risk Cannot Be Distinguished From Class, FDA Says
Labeling for Sanofi-Aventis’ macrolide antibiotic telithromycin increases warnings about liver toxicity and myasthenia gravis.
Ketek Risk Cannot Be Distinguished From Class, FDA Says
Labeling for Sanofi-Aventis’ macrolide antibiotic telithromycin increases warnings about liver toxicity and myasthenia gravis.
Sanofi-Aventis Voluntarily Pauses Ketek Pediatric Trials Pending FDA Consultation
The decision to stop pediatric studies of the antibiotic was not at FDA’s request or due to safety concerns, the company says.