Ketek: A Controversial Antibiotic Implicated In Liver Failure
Ketek (telithromycin) is an antibiotic manufactured by Sanofi-Aventis, and was approved by the FDA on April 1, 2004.
Ketek has been associated with liver failure. If you or a family member suffered from liver failure while using Ketek, please call Skikos, Crawford, Skikos, Joseph & Millican for a free consultation.
Ketek's Approval Mired In Controversy
Ketek was approved after controversy surrounding fraud in one of the clinical studies submitted during the approval process. The findings of fraud resulted in criminal convictions and referrals for criminal investigations of some of the physicians who conducted the study.
Unfortunately, when the study was presented to the FDA advisory committee that was reviewing the drug for approval, no mention was made of the fraud associated with the study. Unaware of the fraud, the committee voted 11 to 1 to recommend approval of the drug.
Reports of Death Surface Shortly After Approval
In February 2005, the first report of a death from liver failure associated with Ketek was reported to the FDA. Little was done by the company or the FDA after this first reported death.
In January 2006, the FDA became aware of a cluster of three cases of acute liver failure reported by just one medical center, which included the fatal case from February 2005. The FDA, however, publicly declared that Ketek was safe, relying on the earlier fraudulent study data.
By June 2006, however, 23 cases of acute severe liver injury and 12 cases of acute liver failure had been reported to the FDA, 4 of them resulting in death. These numbers continued to rise, and by the end of 2006 there were 53 reported cases of serious liver injury.
It was not until June 29, 2006, 16 months after the first report of liver failure associated with the drug, that Sanofi-Aventis revised the Ketek label to include a warning about liver toxicity associated with the drug.
Congress Gets Involved
In the spring of 2006, Congress began investigating the approval and post-marketing surveillance with regard to Ketek. On December 13, 2006, Congress issued its preliminary findings, blasting the FDA and Sanofi-Aventis for their handling of the issues surrounding the drug.
Continued Scrutiny of Ketek by the FDA
On February 12, 2007, the FDA announced that it was removing two of the three previous uses for Ketek from the label, including acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. Ketek was allowed to remain on the market to treat community acquired pneumonia of mild to moderate severity (acquired outside of hospitals or long-term care facilities).
The FDA also announced that a black box warning would be included in the Ketek label indicating that the drug should not be used in patients with myasthenia gravis, a disease that causes muscle weakness. Patients with that disease may experience worsening of symptoms including death associated with the use of Ketek.
By April 2008, Ketek had been linked to 18 reports of death and 134 reports of liver damage. The actual incidences of death and liver injury are likely many times greater given that only a small number of injuries from pharmaceutical drugs are ever reported to the FDA.
Contact Us If You Have Suffered Liver Injury After Using Ketek
If you or a family member has suffered liver injury or other serious injuries as a result of using Ketek, please contact Skikos, Crawford, Skikos, Joseph & Millican for a free case evaluation.
