Ketek Labeling to Include Strong Liver Warning
The FDA and Sanofi-Aventis, the makers of Ketek, have announced that Ketek's labeling will now include a strong warning about serious and potentially fatal Ketek liver side effects and other serious injuries. While developing serious Ketek side effects is rare, dozens of people have been seriously injured because of this medication.
The FDA has received at least 14 reports of acute liver failure caused by Ketek. Of these patients, four died due to Ketek liver failure side effects. A fifth patient required a liver transplant. At least 23 other patients have suffered serious liver injuries due to Ketek.
The FDA approved the antibiotic Ketek in 2004 to treat bronchitis, sinusitis, respiratory tract infection, and pneumonia.
The new Ketek label warns patients and doctors to watch for the development of hepatitis symptoms including fatigue, jaundice, anorexia, malaise, and nausea. (Source)
