January 20, 2006—An article published in the Annals of Internal Medicine reported that Ketek (telithromycin) was linked to three cases of liver damage, resulting in the death of a North Carolina man. The article discussed three patients at the Carolinas Medical Center in Charlotte, North Carolina who were seriously harmed after using Ketek.
Martin & Jones has compiled important information on the side effects of Ketek and reports of serious liver problems in patients. If you or a loved one developed serious liver problems following use of Ketek, we encourage you to contact us.
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July 18, 2006—Dr. David Graham, an official with the FDA's drug safety office, argued in a June 16, 2006 memo that Ketek should be withdrawn. He described approval of the drug as a "mistake" and contended that "every principle concerning the review and approval of new drugs was abandoned or suspended where [Ketek] is concerned."
Dr. Graham is extremely critical of an agency that has taken enormous heat for its poor handling of the Vioxx recall. He believes the benefits of Ketek are outweighed by the risk of serious liver problems.
Dr. Graham may not be alone in believing the agency should issue a recall. Dr. Charles Cooper, Dr. David Ross and Dr. Rosemary Johann-Liang all have expressed grave concerns over the safety profile of Ketek.
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More than 5 million prescriptions for Ketek have been written in the United States since its approval in 2004.
The FDA has linked at least 14 cases of liver failure in people taking Ketek. Four of those patients died as a result of the failure. An additional 23 patients have suffered serious liver injury. Because many adverse reports go unreported to the FDA, it is likely the number of people harmed by Ketek is substantially greater.
Sanofi-Aventis, the manufacturer of Ketek, first applied for approval from the FDA in February 2000. Information from the company's own clinical trials indicating the antibiotic could be associated with liver problems led the FDA to seek more information from the company.
The manufacturer then initiated a study with 24,000 patients, which contained repeated instances of fraud, according to FDA investigators. The company frequently concealed important safety information that it was required to disclose to the FDA.
In spite of concerns over the safety of Ketek, the FDA approved the drug in April 2004.
February 2000
Sanofi-Aventis submits application to FDA seeking approval of Ketek.
June 2001
FDA declines application for Ketek, seeks more information about safety.
October 2001
Aventis enrolls patients for study to assess safety of Ketek.
January 2003
FDA again declines approval of Ketek.
April 2004
In spite of safety concerns, FDA approves Ketek for sale in the United States.
February 2005
North Carolina man dies of liver failure after taking Ketek.
Martin & Jones has been successfully representing injured men, women and children since 1982. We are proud to represent people from all walks of life, and the law firm has the experience and resources to aggressively do so, regardless of the size and resources of the offending company.
If you or a loved one has been diagnosed with liver problems following use of Ketek, you may be entitled to compensation. You should immediately contact lawyers experienced in handling cases involving dangerous pharmaceuticals.
For more information about Ketek and reports of serious liver problems, please complete our online contact form.
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