Ketek is a prescription antibiotic made by Aventis Pharmaceuticals for the treatment of pneumonia, throat and sinus infections and chronic bronchitis, as well as serious or multi-drug resistant infections. Ketek is in a class of drugs called ketolide antibiotics, and is the first FDA-approved antibiotic of that class.
Ketek was approved by the FDA in April 2004 and has been prescribed over five million times in the treatment of bacterial infections. It has been shown to cause liver damage, liver failure, and death. Ketek had been disapproved twice by the FDA prior to 2004. The FDA claimed that both disapprovals were prompted by concerns regarding the safety of Ketek.
In May 2006, the FDA recommended that a black box warning be added to the Ketek label, stating that “severe, life-threatening, and in some cases fatal” liver toxicity has been reported in patients taking the drug. The recommendation came after FDA safety reviewers found that Ketek has been linked to 12 cases of liver failure, including four deaths in the US. In some cases, liver damage worsened rapidly and happened after just a few does of Ketek. While this FDA advisory panel did not recommend a Ketek recall, according to a December 2006 report on CBS News, there was a Congressional probe underway to determine whether Ketek should remain on the market.
In 2008, it was estimated that Ketek had caused 18 deaths and 134 cases of liver damage.
Serious side effects may include:
- Diarrhea that is watery or bloody
- Severe dizziness, fainting, fast or pounding heartbeats
- Confusion, hallucinations
- Problems with vision (difficulty focusing, double vision)
Less serious side effects may include:
- Mild diarrhea
- Mild nausea, vomiting
- Vaginal itching or discharge taste