Home » Ketek Case Shows FDA Actions, Ultimate Impact of Falsified Data
Ketek Case Shows FDA Actions, Ultimate Impact of Falsified Data
November 4, 2010
Ketek, known generically as telithromycin, received European approval in July 2001. The FDA approved Ketek in 2004, despite an ongoing criminal investigation of one of the clinical investigators involved in enrolling study participants. That doctor was later sent to prison for submitting false study data. Then, in January 2006, reports emerged of patients suffering liver damage and liver failure after taking Ketek. Some of these cases led to death. The manufacturer, Sanofi-Aventis, stopped marketing the drug and an investigation was conducted. The Annals of Internal Medicine published an article reporting on three patients who experienced serious liver toxicity following administration of Ketek.