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Ketek, known generically as telithromycin, is a prescription antibiotic used to kill bacteria that cause sinus and other respiratory infections, including chronic bronchitis and pneumonia. On June 28, 2006, the U.S. Food and Drug Administration ordered Sanofi-Aventis, the drug’s manufacturer, to put a stronger warning on the medication’s labels because of its link to serious liver injury, liver failure and death. More than 5 million people have been prescribed Ketek since the FDA approved the drug in 2004. However, in a June 2006 email from one FDA drug safety official to another, it was stated that the approval of the controversial antibiotic should be withdrawn. Soon after the June 16 email, the FDA announced changes to Ketek’s label to include warnings about liver injury and death, and information about reports of fatal worsening of the neuromuscular condition, myasthenia gravis.
According to an internal FDA memo, the FDA has received reports of 14 cases of acute liver failure in patients treated with Ketek, including four deaths. FDA safety evaluators also uncovered 23 other cases where patients suffered serious liver injuries after receiving telithromycin. While other antibiotics can cause liver failure, Ketek does so almost four times as often, concluded safety officials.
In addition to liver problems, side effects of Ketek include blurred vision and loss of consciousness. The FDA knows of three reported deaths in myasthenia gravis patients taking Ketek. These deaths occurred separately from the reported liver problems.
Of the patients who died, examination of their livers showed massive tissue death. All had been healthy prior to the use of Ketek, and had not been using other prescription drugs. Other known side effects of Ketek include hepatitis, jaundice, drowsiness, dizziness, diarrhea, headache, blurred vision or double vision, and nausea and vomiting.
If you are taking, or have ever taken Ketek, you should know that liver damage can be sudden. Symptoms of Ketek liver problems include:
- Jaundice, or yellowing of the whites of the eyes and/or skin
- Abdominal pain in the upper right side
- Flu-like symptoms, including elevated temperature, fatigue and nausea
- Loss of appetite
- Dark urine or clay-colored stools
- Drowsiness or dizziness
- Elevated liver enzyme levels
Our office is currently investigating potential claims regarding side effects from the use of Ketek. If you or a family member has suffered acute liver failure or other injuries due to Ketek, you may be eligible to file a claim. Call Keel O’Malley, LLP, at (252) 823-2266 or toll free (800) 755-1987 or
submit an online questionnaire. The initial consultation is free of charge, and if we agree to handle your case, we will work on a contingency fee basis, which means we get paid for our services only if there is a monetary recovery of funds.
In many cases, a lawsuit must be filed before an applicable expiration date, known as a statute of limitations. Please call right away to ensure that you do not waive your right to possible compensation.
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