Ketek Recall:
Following concerns of Ketek related liver damage, liver failure, or death many advocacy groups are asking for a Ketek recall. According to information posted by the FDA pre-marketing clinical studies, including a large safety trial and data from other countries, the occurrence of liver problems was infrequent and usually reversible. 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 such as Tequin (Gatifloxacin), Zithromax (Azithromycin), aka. Z-Pak, and Keflex (Cephalexin). Nonetheless, the product label advises doctors about the potential for liver-related adverse events associated with the use of telithromycin. In June of 2006 as a result of scrutiny from medical professionals as well as public advocacy groups the FDA asked Sanofi-Aventis to halt an ongoing study of Ketek use in children because it could be deadly. Ketek was being tested as a treatment for ear infections and tonsillitis in nearly 4,000 infants and children in more than a dozen countries, including the United States when the FDA asked Sanofi-Aventis to stop the trial.

Ketek Liver Damage:
On January 20, 2006, the FDA sent out a "Public Health Advisory" indicating that several people have experienced severe Ketek side effects including liver damage after using Ketek (Telithromycin). As a result of such serious Ketek side effects the FDA wants the makers of Ketek, Sanofi-Aventis, to revise the Ketek patient information label to include additional warnings and precautions regarding Ketek liver damage / liver toxicity. To date Ketek is known to be responsible for 12 cases of Ketek liver failure and 4 Ketek deaths.