Ketek Injury Lawyers
Personal Injury Lawyers - Representing People Nationwide
Ketek (telithromycin) is a semi-synthetic antibiotic derived from erythromycin. It is made and marketed by Sanofi-Aventis, and is used to treat mild to moderate respiratory infections. Ketek is administered as tablets, and received US Food and Drug Administration FDA approval in April 2004.
The modifications made to the erythromycin derivative give Ketek (the only ketolide on the market) much broader spectrum (effective against more types of bacteria) than other drugs in its group (macrolides). It prevents bacteria from growing by interfering with their protein synthesis.
Known common side effects associated with the use of Ketek include nausea, diarrhea, vomiting, and abdominal pain. And less common side effects include headache, disturbances in taste, palpitations, rashes, and blurred vision. But in January 2006, rare but severe adverse effects involving damage to the liver was reported. The FDA's Office of Epidemiology and Surveillance has since continued to identify additional cases of acute liver failure, some resulting in deaths.
Then on February 12, 2007, the FDA announced safety related changes to the labeling of Katek. The agency also announced that Keteks sponsor had agreed to the distribution of a MedGuide (Medication Guide) for patients.
The announcement indicates that Ketek is no longer be approved for the treatment of acute bacterial exacerbation of chronic bronchitis due to Haemophilus, Streptococcus pneumoniae, Moraxella catarrhalis, or influenzae, and acute bacterial sinusitis due to Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis.
It also points out that the updated label includes a contraindication and a boxed warning stressing that no one with myasthenia gravis should take Ketek. Warnings were also strengthened for liver injury (hepatoxicity), visual disturbances, and loss of consciousness.
At least one FDA official has been quoted arguing that Ketek should never have been approved and that it should be immediately withdrawn. If you or a loved one has been injured as a result of using Ketek, you may be entitled to compensation. Contact a qualified pharmaceutical injury attorney for an evaluation of your case.