Ketek is the brand name for the ketolide antibiotic, Telithromycin, which is used to treat mild to moderate respiratory infections. Ketek has been under extensive investigation by the FDA due the fact that clinical trials for this drug are known to have been fraudulent.

The FDA has been highly criticized for the approval of Ketek. In 2001 and 2003, Ketek was turned down by the FDA, due to the fact that Aventis could not offer enough evidence to prove their drug was safe. In 2004, Ketek was finally approved by the FDA for the treatment of many conditions such as respiratory tract infections, sinusitis, bronchitis, and even types of pneumonia.

One of the most negative and harmful side effects of Ketek are liver problems. In 2007, the FDA instructed Sanofi-Aventis to put a warning on the Ketek label about the serious side effects, including liver failure. Also a Public Health Advisory was issued in 2006 concerning the acute liver problems associated with people who have used Ketek.

Sanofi-Aventis and the FDA had prior knowledge that Ketek caused serious liver problems and even liver failure. Our firm has become aware that the Sanofi-Aventis and the FDA knew of these serious side effects long before the issuance of the Public Health Advisory. Data from a 2003 advisory committee has suggested that in addition to liver failure and death, Ketek has also been linked to heart and eye toxicity.

In April 2008, an analysis that was performed using information from the FDA linked approximately 18 deaths and 134 cases of serious liver damage to the use of this defective drug. Other reported symptoms are blurred vision, palpitations, and rashes.

It is only right that the FDA be criticized for allowing Ketek to pass the inspections. There has been well documented proof that the clinical trials for Ketek were fraudulent, but the FDA approved this defective drug knowing that this occurred and serious side effects were possible. Sanofi-Aventis should be held liable for the many injuries that have been reported by the use of this defective drug. If you or a loved one has suffered injuries from the use of Ketek, please contact Goggins & Associates so that we may assist you in your case.