Ketek Liver Damage
On January 20, 2006, the FDA sent out a "Public Health Advisory" indicating that several people have experienced liver damage after using Ketek (Telithromycin). As a result of such serious Ketek side effects, the FDA added a "Black Box Warning" to the Ketek label, advising physicians and patients of an increased risk of liver damage. To date, Ketek is known to be responsible for hundreds of 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 failure 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.

On January 25, 2008 The House Oversight and Investigations Subcommittee subpoenaed FDA investigators stating they ignored "red flags" about the bogus data in Ketek's FDA approval submission. To date, Ketek is still available and on the market.

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.

Ennis & Ennis, P.A. is a national law firm specializing in mass tort law with offices in Washington DC and throughout Florida.