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.
What Is Ketek?
Telithromycin is an antibiotic of the ketolide class. It was the first antibiotic of this class to be approved by the FDA in April, 2004 for the treatment of respiratory infections in adults caused by several types of susceptible microorganisms including Streptococcus pneumonia and Haemophilus influenzae
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 News Archive>>>
If you are currently taking Ketek and have concerns about its safety, you should consult with your doctor regarding your treatment options. Under no circumstances should you discontinue taking any medication, including Ketek, without first consulting with your doctor.
If you or a loved one have experienced liver damage, liver failure, or Stevens Johnson Syndrome as a result of Ketek side effects contact the Ketek attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and Ketek attorney are standing by to answer any questions you may have regarding Ketek side effects, a possible Ketek class action lawsuit, or any other type of Ketek litigation.
