Ketek Liver Damage and Liver Failure Lawsuits

Ketek (telithromycin), manufactured by Sanofi-Aventis, was approved in 2004 for the treatment of acute bacterial infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. On January 20, 2006, researchers reported three cases of severe liver problems, including one death, in patients at a North Carolina hospital after they began taking the antibiotic Ketek. The FDA is continuing to evaluate the issue of liver problems in association with use of Ketek in order to determine if labeling changes or other actions are warranted.

Ketek (telithromycin) Information

On January 20, 2006, Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). These cases have also been reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan. While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, the FDA is continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted.

What is telithromycin?
Telithromycin is an FDA approved antibiotic drug, which belongs to the ketolide class, marketed in the U.S. by Aventis under the brand name Ketek. Telithromycin was approved in the U.S. in April 2004.

What is telithromycin used to treat?
Ketek (telithromycin) is indicated for the treatment of very serious bacterial infections, such as community-acquired pneumonia (including multi-drug resistant Streptococcus pneumoniae), acute bacterial sinusitis, and acute exacerbation of chronic bronchitis.

Why are the three reports described in the Annals of Internal Medicine significant?
These reports are significant due to the serious nature of the adverse events. All three patients had jaundice and abnormal liver function. One patient recovered, one required a transplant, and one died. All three patients had previously been healthy.

Did FDA know about these reports prior to this publication?
Yes. The FDA's MedWatch program received reports of the three serious adverse events following administration of telithromycin that were published in the Annals of Internal Medicine.

FDA has also received other reports of liver-related adverse events in patients taking telithromycin. Some of these reports were difficult to interpret because they involved patients already taking other medicines or patients with other medical conditions that might cause liver problems. In pre-marketing clinical studies, including a large safety trial, the occurrence of liver problems was infrequent and usually reversible.

What actions did FDA take regarding these reports?
The Office of Drug Safety looked at adverse events, including hepatic adverse events, in a consult in June 2005 and concluded that there was no new information that changes its assessment of the hepatic risks.

What information was known about telithromycin liver problems prior to approval?
Based on the pre-marketing clinical data it appeared that the risk of liver injury with telithromycin was similar to that of other marketed antibiotics.

FDA looked extensively at the potential for hepatic toxicity in patients treated with Ketek. Data was examined from clinical studies, as well as information in nearly 4 million postmarketing prescriptions outside the United States. Ketek was the subject of two advisory committee meetings with input from a national expert on drug-induced liver disease. The committee concluded that the risk for hepatotoxicity from Ketek was similar to Augmentin and erythromycin which are other approved antibiotics.

What should patients do regarding this new information?
Patients who have been prescribed telithromycin and are not suffering side effects such as jaundice should continue taking their medicine as prescribed.

Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare providers.

What should healthcare providers do in response to this new information?
Healthcare providers should monitor patients taking telithromycin for signs or symptoms of liver problems. Telithromycin should be stopped in patients who develop signs or symptoms of liver problems. As with all antibiotics, telithromycin should only be used for infections by a susceptible microorganism; telithromycin is not effective on viral infections, so a patient with a viral infection who took telithromycin would be taking a risk without any benefit.

What additional actions are likely to follow?
Telithromycin is marketed and used extensively in many other countries, including Japan and countries in Europe. The FDA is working with regulatory authorities in these other countries to obtain further information on reports of liver problems associated with the use of telithromycin. While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.

Legal Help for Ketek Liver Damage Victims

If you or a loved one experienced liver failure, hepatitis, liver damage, liver toxicity during or after taking Ketek, contact The Willis Law Firm today. We provide a free consultation for Ketek victims and their families. Fill out our Free Online Case Evaluation or call us toll free at: 1-800-883-9858.