Investigations: Ketek

Liver damage associated with the antibiotic Ketek.

In May 2006, the U.S. Food & Drug Administration (FDA) recommended that a “black box” warning be added to the labeling for the antibiotic Ketek (generic name “telithromycin”) stating that “severe, life-threatening, and in some cases fatal” liver toxicity had been reported in patients taking the drug. This recommendation came after safety officers from the FDA found that Ketek had been linked to 12 cases of liver failure, including four deaths, in the United States.

Ketek was approved by the FDA in April 2004 for the treatment of “community-acquired” pneumonia (pneumonia acquired outside of hospitals or other health-care facilities), chronic bronchitis, and acute bacterial sinusitis. Ketek was originally approved by the FDA for treatment of community-acquired pneumonia because of its ability to fight bacteria that is resistant to other standard antibiotics such as penicillin and tetracycline.

Aventis Pharmaceuticals, the manufacturer of Ketek, initially submitted their new drug application for Ketek to the FDA in March 2000. Because of numerous safety and efficacy issues, the drug went through two separate advisory committee reviews before finally being approved for the U.S. market in April 2004.

The most common side effects experienced with Ketek use are similar to those associated with other antibiotics: headaches, dizziness, nausea, and diarrhea. However, Ketek has also been shown to increase the user’s risk of liver failure at almost four times the rate of most other antibiotics. Additionally, there have also been reports of blurred vision and loss of consciousness in adults taking Ketek.

Most recently, in May 2006, an official from the FDA called for Aventis Pharmaceuticals to stop clinical trials in which Ketek was being tested as a treatment for tonsillitis and ear infections in both infants and children. According to internal FDA memoranda, there was sufficient concern regarding the possibility of fatal liver failure in the children being given Ketek to warrant halting the trials.

If you believe that you, or someone you know, may have suffered liver damage as a result of taking Ketek, please call Lewis Saul & Associates toll-free at (888) 747-5342 or fill out our convenient online contact form and a member of our firm will contact you for a free consultation.