On November 14, 2006, the Food and Drug Administration (FDA) requested that a panel of outside experts examine the antibiotic Ketek to weigh its overall risks and benefits. At a December meeting, the FDA panel will examine reports that Ketek, an antibiotic made by Sanofi-Aventis, may be linked to serious personal injury in its patients, including reports of liver failure and death.

Despite being rejected twice before gaining approval in the US, more than 5 million prescriptions for Ketek have been written since its introduction. Ketek is used to treat mild to moderate respiratory tract infections, including acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and certain types of pneumonia.

In May 2006, FDA officials called for the halt of clinical trials of Ketek in children because of its possible hepatoxicity and reported links to serious personal injury. The FDA has received 12 reports of acute liver failure in Ketek patients, including four deaths. In April 2006, a New York Times report stated the FDA had received over 100 adverse event reports of liver problems in patients using Ketek. Ketek has also been associated with blurred vision and loss of consciousness in adults.

Source: Victoria Harrison, “FDA will examine safety of Sanofi antibiotic,” Pharmaceutical Business Review Online, November 16, 2006, accessed November 16, 2006.