Ketek® Can Cause Serious Liver Damage
The antibiotic Ketek® may be dangerous to your health. Although it is prescribed to treat bronchitis, sinus problems and a type of pneumonia, the drug can damage your liver and affect your eyesight.
Ketek® has caused 23 liver injuries, 14 liver failures and four deaths from the time it went on the market in April, 2004 until 2006, according to the NY Times (June 29, 2006). The newspaper based its figures on reports to the Food and Drug Administration (FDA), the agency charged with guarding the public health.
The FDA now advises Ketek® users to watch for any signs of liver disease. If you are taking Ketek® and feel tired, lose your appetite, get a queasy stomach, and develop jaundice (yellowing skin and eyes), see your doctor at once. These are classic signs of liver disease. Ketek® may also cause blurred vision, double vision, or the inability to focus—all side effects listed in the prescribing instructions for the drug.
Warning About Ketek® Side Effects: Too Little, Too Late?
The manufacturer of Ketek®, Sanofi–Aventis, began a study in which it planned to test Ketek® on 4,000 children. They would be treated for ear infections, a malady that sometimes clears up on its own. After a rash of bad publicity about Ketek® and liver injuries, the company “paused” the study.
Sanofi–Aventis changed the prescribing instructions for Ketek® to warn people about liver failures only after the FDA published a Ketek® alert (FDA News, June 29, 2006). The agency had issued a public health advisory months before describing the link between Ketek® and liver damage (Public Health Advisory, January 20, 2006). Also, an article in a noted medical journal had considered the records of three otherwise healthy people who had taken Ketek® (Ann Intern Med., 2006 Mar 21; 142; Ann Intern Med., 2006 Mar 21; 144(6): 415–20). One suffered a severe liver injury, one needed a liver transplant, and one died from liver failure.
Three members of Congress have questioned whether the FDA relied on bad data to approve the sale of Ketek®. They pointed out that a doctor who recruited patients for Ketek® studies was convicted for providing fake data. They also charged that the agency relied on foreign reports that were issued after the drug went on the market (Letter to FDA, Sen. Edward Markey and Rep. Henry Waxman, May 1, 2006; Press Release, June 22, 2006).
What is Ketek®?
Ketek® is the brand name for the chemical telithromycin. The antibiotic is used to treat sinus infections, bronchitis and pneumonia when they are caused by bacteria. The drug has no effect on viruses, which may cause other forms of these illnesses.
Besides liver damage and eye problems, other side effects of Ketek® include headaches, nausea, dizziness, vomiting and diarrhea. You should not take Ketek® if you have myasthenia gravis, a disease in which the immune system attacks the muscles and nerves. Using Ketek® can make this condition much worse.
Your Ketek® Case
Brayton Purcell is currently reviewing the health problems faced by people who took Ketek®. If you or a family member suffered liver damage after taking Ketek®, please contact us . We will evaluate your case free of charge, answer your questions, and explain your legal rights. Each state has a deadline for filing legal claims once you have been injured. Therefore, we suggest that you contact us as soon as possible to get legal information if you have been injured by an unsafe drug.
Related Articles
- March 2, 2007
- FDA Restricts Use of Antibiotic Ketek®
- December 22, 2006
- Use of the Antibiotic Ketek® Should Be Limited, FDA Panel Says
- December 1, 2006
- FDA To Once Again Consider the Dangers of Ketek®