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On February 12, 2007, the FDA announced that it was rescinding its approval of Ketek® to treat bronchitis and sinusitis. The FDA stopped short of removing Ketek® from the market entirely, instead allowing its use to treat certain strains of community-acquired pneumonia and adding a black boxed warning about myasthenia gravis, a disorder that causes muscle weakness and can affect vision.
To read the FDA’s announcement, click HERE
Meneo Law Group Press Release
Iraq War Veteran Suffers Liver Failure After Taking Antibiotic Ketek®
The first personal injury lawsuit involving the antibiotic Ketek®, was filed today in Middlesex County on behalf of Chuck Gregg against the drug's manufacturer Sanofi-aventis... read more
Also, to view Chuck Gregg's story as it appeared on the CBS Evening News, click on the play button below
Ketek® (Telithromycin)
Telithromycin, known by its brand name Ketek® - is a prescription antibiotic manufactured by Aventis Pharmaceuticals, Inc. Ketek® is in the class of antibacterial agents known as ketolides and was approved for use in the United States in April, 2004. Since then, approximately 5 million prescriptions for Ketek® have been written.
Ketek® is approved for the treatment of respiratory infections in adults. Such infections include sinus infections (sinusitis), lung infections, pneumonia and bacterial chronic bronchitis. Ketek® is thought to be stronger than traditional antibiotics and able to combat bacterial infections that have developed a resistance to the traditional antibiotics.
The use of Ketek® has recently been associated with the onset of liver disease and, in some cases, acute liver failure. An article that appeared in the January, 2006 issue of the Annals of Internal Medicine - entitled "Brief Communication: Severe Hepatotoxicity of Telithromycin: Three Case Reports and Literature Review" - reported about three patients who suffered "drug-induced" liver toxicity that was believed to be associated with each patient's use of Ketek®. Of these three patients, one required a liver transplant and one died. After a review of each case, the authors concluded that in all three, the liver failure was secondary to the ingestion of Ketek®
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Ketek® and Liver Failure
An FDA safety review indicates there have been at least 53 Adverse Event Reports of serious liver toxicity associated with Ketek®. 12 involved liver failure, as well as 4 deaths and 23 serious liver injuries. Additional FDA reports associated liver problems with Ketek®. On June 29, 2006, a change to the Ketek® label was made to strengthen the warning about the risk of liver toxicity.
Serious allegations have been made about the scientific integrity of data that was used in the main study offered to demonstrate the safety of Ketek®. The lead investigator of this study was pled guilty to mail fraud charged stemming from the falsification of data used in the study. Senator Charles Grassley has spearheaded a Congressional investigation into the FDA’s handling of the Ketek® approval process.
FDA Advisory Committee Meeting
On December 14 – 15, 2006, an FDA Advisory Committee conducted a meeting to review the safety and efficacy of Ketek®. At the conclusion of that meeting, the Committee recommended that Ketek® should not be prescribed for the treatment of bronchitis and sinusitis – 2 of the 3 indicated uses for which Ketek® was approved. While the Committee recommended that Ketek® should still be used to treat certain pneumonia, it suggested that warnings be strengthened and that information about safety concerns be made widely available to doctors and patients.
In the midst of these very serious concerns, Ketek® was being tested in a pediatric population of 4,000 infants and children. The clinical trial was designed to test the efficacy of Ketek® to treat ear infections and tonsillitis. The infants and children ranged in age from 6 months to 13 years and were participating in one of 4 separate trials that were approved by the FDA. The trials were halted earlier in 2006.
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If you or a loved one developed liver disease or failure, or symptoms of liver failure, during or after treatment with Ketek®, please click HERE for information about your potential legal rights.
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