If You have suffered Liver Failure or had a LiverTransplant:
Your injury may have been caused by Ketek—

Ketek is an antibiotic manufactured by Sanofi-Aventis (SA) and was approved for the U.S. market by the Food and Drug Administration (FDA) in April 2004 to treat acute bacterial bronchitis, sinusitis, and pneumonia. Ketek is in a class of drugs called ketolide antibiotics; its pharmaceutical name is telithromycin (teh-lih-throw-MY-sin). Ketek fights bacteria in the body, and is used to treat bacterial infections in the lungs and sinuses. Ketek may also be used for purposes other than those listed in the medication guidelines.

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.

More than 5 million prescriptions for Ketek have been written in the United States since its approval in 2004. The drug has been associated with at least 14 cases of serious liver injury and liver failure with four reported deaths and one liver transplant after the administration of the drug. Because many adverse reports go unreported to the FDA, it is likely the number of people harmed by Ketek is substantially greater

The Food and Drug Administration notified healthcare professionals and patients that it completed its safety assessment of Ketek (telithromycin). FDA determined that additional warnings are required and the manufacturer is revising the drug labeling to address this safety concern. FDA is advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems.