6/30/2006: Warning for increased risk of liver damage as a side effect of the antibiotic Ketek will be required following several reported cases of patients with liver failure and death.
NEWS ALERT 6/30/2006: A new warning label will be added to the antibiotic Ketec following reports that it leads to an increased risk of liver failure. This warning follows several weeks of debate surrounding fraud which was discovered in the clinical trials for FDA approval. The manufacturer, Sanofi-Adventis, has finally agreed to modify the Ketek warning label to better disclose the increased risk of liver damage, which could lead to death.
Although the new antibiotic warning label is not a black box warning (the strongest warning which can be placed on a medication), it is a much stronger warning than what was previously on the antibiotic. Previously the manufacturer only cautioned of possible liver dysfunction, and stated that such events were “generally reversible”. The new Ketek warning label discloses that there have been reported increased risks of acute hepatic failure and liver injury, which has been fatal in some cases.
The label also warns of possible death and life threatening respiratory failure for patients with myasthenia gravis, a neuromuscular disease with symptoms of weakness and fatigue.
Ketek is an antibiotic used to treat respiratory tract infections, sinusitis, pneumonia and bronchitis. It was approved by the FDA in 2004, but recent congressional investigations have been initiated regarding the FDA approval after disclosure of fraud and false reporting during clinical trials which misrepresented the antibiotics safety.
KETEK SIDE EFFECT INJURY CLAIMS
Despite the increased risk of liver damage associated with Ketek when compared with similar antibiotics, the manufacturer has minimized the risk of life-threatening liver failure. Ketek manufacturer’s failure to warn of the possibility of serious liver damage has caused many users to suffer serious injuries without having a change to decide with their physicians if they believe the risk was acceptable for an antibiotic.
The Saiontz and Kirk medication side effect lawyers are currently investigating claims against the manufacturer for any users of the antibiotic Ketek, who suffered liver damage, liver failure, acute respiratory failure or death. Request a free consultation to review your legal rights and determine if you may be entitled to compensation.
Saiontz & Kirk is a law firm which investigates and pursues claims for serious injuries sustained nationwide as a result of defective and dangerous medications. A toll free injury hotline (800) 522-0102, is available for any individuals who suspect that they may have suffered an injury as a result of a defective medication. In addition, free consultations and claim evaluations can be requested through our website at https://www.youhavealawyer.com.