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this pageAntibiotic Ketek® Linked to Liver Failures
WASHINGTON, DC — July 7, 2006 — The antibiotic Ketek® (telithromycin) can pose “serious health risks,” the Food and Drug Administration (FDA) warned in a recent press release (FDA News, June 29, 2006). The drug has been linked to severe liver injury, liver failure and deaths.
The FDA announcement was the product of months of debate within the agency about the dangers of Ketek®, the New York Times reported (NY Times, June 29, 2006). Since the drug was approved in 2004, there have been 23 cases of serious liver injury related to Ketek® as well as 14 cases of liver failure, including four deaths, according to the newspaper account.
The FDA now advises Ketek® users and their doctors to be alert for symptoms of liver disease. The signs include:
- Fatigue
- Loss of appetite
- Nausea
- Yellow skin
- Dark–colored urine
Other Ketek® Side Effects
Ketek® is prescribed to treat sinusitis, bronchitis and community–acquired pneumonia, when these conditions are caused by bacteria. In addition to liver injuries, other Ketek® side effects include blurred vision, visual focusing difficulties, double vision, intense colitis and fainting. Patients who have myasthenia gravis should not take Ketek® because it may greatly aggravate the disorder. Myastenia gravis is a disease in which the immune system attacks the muscles and nerves.
Ketek® Label Revised; Clinical Trial Halted
As a result of the FDA announcement, Ketek®’s manufacturer, Sanofi–Aventis, has revised its prescribing instructions for the drug. The section labeled “Warnings” now notes “Acute hepatic [liver] failure and severe liver injury, in some cases fatal, have been reported in patients taking Ketek®.” As of the date of this story, the company does not include this warning in the patient section of the company’s Ketek® web site, unless they access the prescribing instructions.
After Ketek® received negative publicity in the NY Times, Sanofi–Aventis also “paused” a clinical trial in which 4,000 infants and children would take the drug to treat ear infections. An infectious disease specialist cited by the newspaper said that most pediatric ear infections clear up in a few days without any treatment. “How does one justify balancing the risk of fatal liver failure against one day less of ear pain?” commented Dr. Rosemary Johann–Liang, an FDA researcher (NY Times, June 8, 2006).
Sens. Chuck Grassley (R–IA), Edward Markey (D–MA) and Rep. Henry Waxman (D–CA) are investigating the FDA’s overall responses to the Ketek® problem. Sen. Grassley charged that the FDA approved Ketek® for the marketplace using falsified clinical data (Press Release, June 22, 2006). Sen. Markey and Rep. Waxman wrote a letter to the FDA making similar charges. They said that a doctor who recruited patients for Ketek® studies was convicted for manipulating and falsifying data and that the agency relied on foreign post–marketing reports to resolve safety issues.
The full text of the letter sent by Sen. Markey and Rep. Waxman is posted on Rep. Waxman’s web site. You will need Adobe Acrobat Reader to access this file. If you do not already have this software, you may download a free copy from the Adobe web site.
Your Medical Drug Case
Brayton Purcell is concerned about unsafe prescription drugs, including Ketek®. If you or a loved one took Ketek® and developed liver damage, please contact us for more information. We will review your case and advise you of your legal options. We have been handling medical/legal cases for over 20 years and are proud of our success in protecting the legal rights of our clients.