 |
|
 |
|
 |
|
Overview
Ketek® (telithromycin), a recently approved antibiotic, has been associated with an increased risk of liver failure. On January 20, 2006, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory in which the FDA warned about the use of Ketek® and potential liver toxicity. The FDA’s action was in response to an article that appeared in the Annals of Internal Medicine in January, 2006.
The article – "Brief Communication: Severe Hepatotoxicity of Telithromycin: Three Case Reports and Literature Review" – described 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®
A criminal investigation of the circumstances surrounding the approval of Ketek® is currently underway. This pending criminal investigation is examining the collection and integrity of safety data that was submitted to the FDA and upon which approval was based. Serious questions have apparently arisen over the accuracy, and some cases validity, of the safety data.
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.
|
 |
|
|
|
|
