Ketek black box warning and label changes

Austin Kirk

By Austin Kirk
Posted February 14, 2007


A Ketek black box warning and restrictions on the use of the antibiotic were announced by the FDA as a result of serious side effects which could lead to liver damage or death.  The announcement comes the same week as a U.S. House subcommittee is holding hearings to examine irregularities in the FDA approval of the drug and reports of fraudulent underreporting of adverse events during clinical trials.

Ketek (telithromycin) is an antibiotic which was approved by the FDA in 2004 for treatment of acute bacterial sinusitis, acute bacterial exacerbations of chronic bronchitis and acquired pneumonia of mild to moderate severity.  Since its introduction it has also been prescribed by many doctors “off-label” for treatment of other conditions.  As a result of heavy marketing by the manufacturer, over 5.6 million prescriptions were written for the antibiotic during the first two years it was on the market in the United States.

The Ketek black box warning and label changes were added as a result of side effects which could lead to potentially fatal injuries.  The FDA has indicated that the antibiotic should not be prescribed for any condition other than pneumonia acquired outside of a hospital or nursing home, since the risk of Ketek liver damage side effects outweighs any potential benefits the antibiotic provides in treatment of sinusitis or bronchitis, which are less serious conditions. 

>>INFORMATION: Ketek side effects

The Ketek label changes come two months after an FDA advisory panel recommended altering the label instead of issuing a Ketek recall.  The warning label was strengthened for Ketek liver injury (hepatoxicity), loss of consciousness and visual disturbances.  A black box warning indicates that the medication should not be used for anyone with myasthenia gravis, a disease which can lead to potentially fatal muscle weakness, as Ketek side effects could aggravate the disease.  A black box warning is the most serious warning which can be placed on a prescription medication by the FDA.

This week a U.S. House subcommittee is holding FDA safety oversight hearings to investigate the Ketek approval process and why the medication was approved when it was known to increase the risk of liver damage which could lead to death.  Lawmakers have accused the FDA and the manufacturer of the antibiotic, Sanofi-Aventis, of failing to question whether the risks of Ketek side effects outweigh the benefits of the drug prior to approval.

During testimony on Tuesday, a former employee of Sanofi-Aventis said that the drug maker was aware of problems with the Ketek study used for FDA approval before regulators discovered the problems with fraud.  The testimony refers to a Ketek study done prior to FDA approval in 2004, where the doctor who enrolled the most patients in the study was charged with fraud and subsequently pled guilty.

Other testimony offered this week at the hearings accused the FDA of approving the antibiotic despite knowledge that Ketek liver damage side effects would kill people.  Since its approval, there have been many reports of liver failure and death linked to the antibiotic.  These injuries could have been prevented if information regarding the Ketek dangers had been disclosed earlier, as there are safer alternatives which could have been prescribed to treat most of the conditions Ketek is used for.

Ketek lawsuits are being reviewed nationwide by Saiontz & Kirk, P.A. for users who suffered liver damage, liver failure, respiratory failure, aggravation of myasthenia gravis or death.  If you, a friend or family member believe you may have a case, request a free claim evaluation.

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